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Report for Clinical Trial NCT01628692

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 2, Open-Label Study of Daclatasvir (BMS-790052) and TMC435 in Combination With or Without Ribavirin (RBV) For Treatment-Naive Subjects or Null Responders to Prior Peginterferon Alfa (PegIFN)/RBV Therapy With Genotype 1 Chronic Hepatitis C

The purpose of this study is to assess the safety and efficacy of daclatasvir and simeprevir with and without ribavirin for genotype 1 chronic hepatitis C virus infection in patients who are treatment-naive or null responders to previous pegylated interferon/ribavirin therapy.

NCT01628692 Hepatitis C Virus
MeSH: Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis
HPO: Hepatitis

3 Interventions

Name: Daclatasvir

Description: Tablets, oral, 30 mg, once daily

Type: Drug

Cohort 1: (Genotype 1b) Daclatasvir + Simeprevir Cohort 2: (Genotype 1b) Daclatasvir + Simeprevir + Ribavirin Cohort 3: (Genotype 1a) Daclatasvir + Simeprevir + Ribavirin Cohort 4: (Genotype 1a) Daclatasvir + Simeprevir + Ribavirin

Name: Simeprevir

Description: Capsule, oral, 150 mg, once daily

Type: Drug

Cohort 1: (Genotype 1b) Daclatasvir + Simeprevir Cohort 2: (Genotype 1b) Daclatasvir + Simeprevir + Ribavirin Cohort 3: (Genotype 1a) Daclatasvir + Simeprevir + Ribavirin Cohort 4: (Genotype 1a) Daclatasvir + Simeprevir + Ribavirin

Name: Ribavirin

Description: Tablets, oral, 500-600 mg, twice daily

Type: Drug

Cohort 3: (Genotype 1a) Daclatasvir + Simeprevir + Ribavirin Cohort 4: (Genotype 1a) Daclatasvir + Simeprevir + Ribavirin


Primary Outcomes

Description: SVR12 rate was defined as hepatitis C virus (HCV) RNA levels to be Measure: Percentage of Participants With Sustained Virologic Response Rate at Post-treatment Week 12 (SVR12)

Time: Post Treatment Week 12 (Follow-up period)

Secondary Outcomes

Description: RVR was defined as hepatitis C virus (HCV) RNA levels to be Measure: Percentage of Participants With Rapid Virologic Response (RVR) at Week 4

Time: Week 4

Description: cEVR was defined as hepatitis C virus (HCV) RNA levels to be Measure: Percentage of Participants With Complete Early Virologic Response (cEVR)

Time: Week 12

Description: eRVR were defined as hepatitis C virus (HCV) RNA levels to be Measure: Percentage of Participants With Extended Rapid Virologic Response (eRVR)

Time: Week 4 and Week 12

Description: EOTR were defined as hepatitis C virus (HCV) RNA levels Measure: Percentage of Participants With End of Treatment Response (EOTR)

Time: End of treatment (Week 24)

Description: Participants were categorized into 3 genotypes based on single nucleotide polymorphisms in the IL28B gene. SVR12 was defined as hepatitis C virus (HCV) RNA levels below lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

Measure: Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) by rs12979860 Single Nucleotide Polymorphisms in the IL-28B Gene Categories

Time: Baseline, post-treatment Week 12 (Follow-up period)

Description: AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.

Measure: Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) and Who Died

Time: From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 rs12979860

HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.. Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) by rs12979860 Single Nucleotide Polymorphisms in the IL-28B Gene Categories.



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