SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT01648140

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II Multicenter, Parallel-Group, Randomized, Dose-Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following 12 Weeks of Oral Administration of GSK2336805 With Pegylated Interferon and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 or 4 Hepatitis C Infection

GSK2336805 is a novel hepatitis C virus (HCV) non-structural 5A (NS5A) inhibitor being developed for the treatment of chronic HCV infection. This Phase II, multicenter, parallel-group, randomized, dose-ranging study will assess the safety and tolerability, antiviral activity, and pharmacokinetics of GSK2336805 at 2 dose levels (40 and 60 mg) in combination with pegylated interferon alfa-2a (PEG) and ribavirin (RIBA) in approximately 100 treatment-naïve subjects with chronic genotype 1 HCV infection. In a separate nonrandomized single-arm cohort, up to 15 treatment-naïve subjects with genotype 4 chronic HCV infection will be enrolled in parallel at the dose level of 60 mg of GSK2336805.

NCT01648140 Hepatitis C, Chronic
MeSH: Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis
HPO: Hepatitis

5 Interventions

Name: GSK2336805 40 mg

Description: 20 mg tablet, round, 10-mm diameter, white to off-white, no markings

Type: Drug

T40

Name: GSK2336805 60 mg

Description: 30 mg tablet, round, 10-mm diameter, white to off-white, no markings

Type: Drug

G4 T60

Name: Pegylated interferon alpha-2a

Description: 180 microgram per 0.5 mL prefilled syringe for single use

Type: Drug

G4 PRT T40 T60

Name: Ribavirin

Description: 200-mg tablet, capsule-shaped, light blue, film-coated, and debossed with "200" on 1 side and the logo "3RP" on the other side

Type: Drug

G4 PRT T40 T60

Name: Telaprevir

Description: 375 mg film-coated tablet

Type: Drug

PRT


Primary Outcomes

Description: eRVR is defined as plasma HCV ribonucleic acid (RNA) Measure: Number of Participants Achieving eRVR

Time: Week 4 and Week 12

Description: An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.

Measure: Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) up to Week 12

Time: From the start of study treatment up to Week 12

Description: Blood pressure measurements were taken to observe vital signs and included SBP and DBP at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and Post-treatment (PT) Follow Up (FU) Weeks 4, 12 and 24. Change from Baseline in SBP and DBP is summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12

Time: Baseline (Week 0) up to 12-week treatment period

Description: Vital sign monitoring included heart rate, measured at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4, 12 and 24. Change from Baseline in heart rate is summarized for each post-Baseline assessment upto Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12

Time: Baseline (Week 0) and Day 2, Weeks 1, 2, 4, 6, 8, and 12

Description: Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the basophils, eosinophils, lymphocytes, total neutrophils, platelet count and white blood cell count values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12

Time: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Description: Blood samples were collected for the measurement of red blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the red blood cell count values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12

Time: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Description: Blood samples were collected for the measurement of hemoglobin at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hemoglobin values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12

Time: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Description: Blood samples were collected for the measurement of hematocrit at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hematocrit values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12

Time: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Description: Blood samples were collected for the measurement of mean corpuscle volume at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the mean corpuscle volume values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12

Time: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Description: Blood samples were collected for the measurement of albumin at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the albumin values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12

Time: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Description: Blood samples were collected for the measurement of ALP, ALT, AST, CK and GGT at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4 Change from Baseline in the ALP, ALT, AST, CK and GGT values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12

Time: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Description: Blood samples were collected for the measurement of direct bilirubin, total bilirubin and creatinine at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the direct bilirubin, total bilirubin and creatinine values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12

Time: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Description: Blood samples were collected for the measurement of Chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12

Time: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Description: Blood samples were collected for the measurement of Creatinine Clearance at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. It is estimated by Cockcroft-Gault Equation. Change from Baseline in the Creatinine Clearance values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12

Time: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

Description: Urine samples were collected for urinalysis at Baseline, Weeks 2, 12, 18, 24, 48 and PT FU Weeks 4. Number of participants with shift from Baseline in urinalysis to normal (NL), abnormal (ANL) and missing (MIS) data up to Week 12 are summarized. Urine bilirubin (UBIL), urine glucose (UGLU), urine ketones (UKET), urine leukocyte esterase test (ULET) for detecting WBC, urine nitrite (UNIT), urine occult blood (UOB) were performed with dipstick method. Urine microscopy (UM) is performed to detect bacteria (BAC), red blood cells (RBC) and white blood cells (WBC). Other urinalysis parameter included urine pH (UpH) and urine specific gravity (USG). Baseline value is defined as the last Pre-treatment value observed.

Measure: Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12

Time: Baseline (Week 0), Weeks 2 and 12

Description: The ECG parameter heart rate was measured at Baseline, Weeks 1 and 12. Change from Baseline in ECG heart rate is summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in Electrocardiographic (ECG) Heart Rate Values at the Indicated Time Points up to Week 12

Time: Baseline (Week 0) and Weeks 1 and 12

Description: The ECG parameters including PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF were measured at Baseline, Weeks 1 and 12. Change from Baseline in ECG parameters are summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12

Time: Baseline (Week 0) and Weeks 1 and 12

Secondary Outcomes

Description: An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.

Measure: Number of Participants With Any AEs and Any SAEs After Week 12

Time: From Week 12 up to PT Week 24 FU

Description: Blood samples for the determination of HCV RNA levels were collected at Screening and Baseline, every study visit during the Treatment Period, and at PT FU Weeks 4, 12, and 24. vRVR is defined as plasma HCV RNA Measure: Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT)

Time: From the start of the treatment up to PT FU Week 24

Description: Plasma pharmacokinetic (PK) samples were collected for all participants on Day 1 (0 hour [h]-1h, 1h-4h, 4h-8h, 8h-20h), Day 2 (Predose [20-28h]), Week 4 (Predose [20-28h], 0h-1h, 1h-4h, 4h-8h, 8h-20h, 20h-28h) and Week 12 (Predose [20-28h]). PK Population is comprised of all participants who received GSK2336805 and underwent plasma PK sampling (intensive or sparse) during the study.

Measure: Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12

Time: Day 1, Day 2, Week 4, and Week 12

Description: Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7, 24 hours post-dose.

Measure: Maximum Plasma Concentration (Cmax) and Concentration at the End of the Dosing Interval (Ctau) of GSK2336805 at Week 4

Time: Week 4 (24 h post dose)

Description: Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7, 24 hours postdose.

Measure: Time of Maximal Plasma Concentration (Tmax) of GSK2336805 at Week 4

Time: Week 4 (24 h post dose)

Description: Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose.

Measure: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) at Week 4

Time: Week 4 (24 h post dose)

Description: Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. CL/F was calculated as dose divided by AUC(0-tau).

Measure: Apparent Clearance (CL/F) at Week 4

Time: Week 4 (24 h post dose)

Description: Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. Vz/F was calculated as dose divided by (AUC[0-tau] lambda z) where lambda z is the terminal phase rate constant.

Measure: Apparent Volume of Distribution (Vz/F) at Week 4

Time: Week 4 (24 h post dose)

Description: Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT Week 4. Change from Baseline in the basophils, eosinophils, lymphocytes, total neutrophils platelet count and white blood cell count values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12

Time: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Description: Blood samples were collected for the measurement of red blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the red blood cell count values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12

Time: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Description: Blood samples were collected for the measurement of hemoglobin at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hemoglobin values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12

Time: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Description: Blood samples were collected for the measurement of hematocrit at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hematocrit values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12

Time: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Description: Blood samples were collected for the measurement of mean corpuscle volume at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the mean corpuscle volume values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12

Time: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Description: Blood samples were collected for the measurement of albumin at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the albumin values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12

Time: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Description: Blood samples were collected for the measurement of ALP, ALT, AST, CK and GGT at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the ALP, ALT, AST, CK and GGT values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12

Time: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Description: Blood samples were collected for the measurement of total bilirubin and creatinine at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the direct bilirubin, total bilirubin and creatinine values are summarized for each post-Baseline assessment afterl Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12

Time: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Description: Blood pressure measurements were taken to observe vital signs and included SBP and DBP at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. As defined in the Reporting Analysis Plan (RAP) for this protocol, the supplemental final data package generated for this study after Week 12 only provided graphical displays of vital signs (e.g., change from baseline for heart rate and blood pressure) to facilitate clinical interpretation and data summarization. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. All abnormal values and statistical summary tables were not available after week 12.

Measure: Mean Change From Baseline in SBP and DBP at the Indicated Time Points After Week 12

Time: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Description: Vital sign monitoring included heart rate, measured at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. As defined in the Reporting Analysis Plan (RAP) for this protocol, the supplemental final data package generated for this study after Week 12 only provided graphical displays of vital signs (e.g., change from Baseline for heart rate and blood pressure) to facilitate clinical interpretation and data summarization. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. All abnormal values and statistical summary tables were not available after week 12.

Measure: Mean Change From Baseline in Heart Rate at the Indicated Time Points After Week 12

Time: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Description: The ECG data was only collected "Perform as needed", therefore, no such summary table was generated. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in ECG Heart Rate Values at the Indicated Time Points After Week 12

Time: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Description: The ECG data was only collected "Perform as needed", therefore, no such summary table was generated. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QTcB, QTcF Values at the Indicated Time Points After Week 12

Time: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Description: Blood samples were collected for the measurement of Chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/bun at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Bun values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last pre-treatment value observed.

Measure: Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12

Time: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Description: Blood samples were collected for the measurement of estimated creatinine clearance by Cockcroft-Gault formula at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the estimated creatinine clearance values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.

Measure: Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12

Time: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

Description: Correlation of individual GSK2336805 40 mg and 60 mg with Week 4 plasma AUC(0-tau) versus eRVR Status (eRVR and no eRVE) was performed. eRVR is defined as plasma HCV RNA Measure: Correlation of Individual GSK2336805 Dose With Week 4 Plasma AUC(0-tau) Versus eRVR Status

Time: Week 4 and Week 12

Description: Correlation of Individual GSK2336805 40 mg and 60 mg dose with Week 4 maximum plasma concentration (Cmax), pre-dose concentration (C0), concentration at the end of the dosing interval (Ctau) versus eRVR status (eRVR and no eRVR) was performed. eRVR is defined as plasma HCV RNA Measure: Correlation of Individual GSK2336805 Dose With Week 4 Plasma Cmax, Ctau, C0 Versus eRVR Status

Time: Week 4 and Week 12

Description: Correlation of individual GSK2336805 40 mg and 60 mg with Week 4 plasma AUC(0-tau) versus eRVR Status (RVR and no eVE) was performed. RVR is defined as plasma HCV RNA Measure: Correlation of Individual GSK2336805 Dose With Week 4 Plasma AUC(0-tau) Versus RVR Status

Time: Week 4

Description: Correlation of Individual GSK2336805 40 mg and 60 mg dose with Week 4 maximum plasma concentration (Cmax), pre-dose concentration (C0), concentration at the end of the dosing interval (Ctau) versus RVR status (RVR and no RVR) was performed. RVR is defined as plasma HCV RNA Measure: Correlation of Individual GSK2336805 Dose With Week 4 Plasma Cmax, Ctau, C0 Versus RVR Status

Time: Week 4

Description: Correlation of individual GSK2336805 dose with pre-dose plasma concentration at Week 4 and Week 12 versus eRVR status was performed. eRVR is defined as plasma HCV RNA Measure: Correlation of Individual GSK2336805 Dose With Pre-dose Plasma Concentration at Week 4 and Week 12 Versus eRVR Status

Time: Week 4 and Week 12

Description: Correlation GSK2336805 pre-dose plasma concentration (ng/mL) on Day 2 versus reduction in HCV RNA (log IU/mL) on Day 2 was performed. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.

Measure: Correlation GSK2336805 Pre-dose Plasma Concentration on Day 2 Versus Reduction in HCV RNA on Day 2

Time: Day 2

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 rs12979860

Randomization will be stratified by interleukin 28B (IL28B) rs12979860 status (C/C versus carriage of the T allele), HCV genotype (1a vs. 1b), and plasma HCV Ribonucleic Acid (RNA) (<800,000 IU/mL versus ≥800,000 IU/mL).



HPO Nodes


HPO:
Hepatitis
Genes 90
CD247 CTNNB1 ATP7B CASP10 PIEZO1 GUSB BLNK SHPK CYP7A1 IL17RA IGF2R CASP8 SH2D1A SLC25A15 BTK BTK C4B CD79B VPS33B XIAP SERPINA1 PIK3R1 GLIS3 POU2AF1 CIITA FOXP3 TPP2 RFX5 CIITA RASGRP1 RFXANK SLC25A15 AXIN1 TCF4 CD3D TP53 IL12A PRKCD CD40LG BTK IGHM IL17RC ALMS1 TRAF3IP2 KRT8 FAS LRRC8A FAS IL17F XIAP SPIB C1S RFX5 RFXAP MST1 TTC7A COG8 SKIV2L VIPAS39 IGLL1 PDGFRL TNFSF15 HSD3B7 CD3E AMACR ATP7B FASLG RFXANK IL12RB1 TCF3 CD79A KRT18 IRF5 MET PIK3CA MMEL1 ITCH TBX19 IL21R AIRE RFXAP TTC7A CLEC7A GPR35 ATP7A CYP7B1 STAT1 PGM1 APC TNPO3