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Report for Clinical Trial NCT01389323

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Open-Label, Single Arm Evaluation of BMS-790052 (Daclatasvir) in Combination With Peg-Interferon Alfa-2a and Ribavirin in Black-African Americans, Latinos and White-Caucasians With Chronic Hepatitis C Genotype 1 Infection

The purpose of this study is to compare the rates of sustained virologic response in each cohort (Black-African Americans, Latinos) in this study to historical rate.

NCT01389323 Hepatitis C
MeSH: Hepatitis A Hepatitis C Hepatitis
HPO: Hepatitis

3 Interventions

Name: Daclatasvir

Description: Tablet, Oral, 60 mg, once daily, 24 weeks

Type: Drug

Arm 1: Daclatasvir + Peg-Interferon Alfa-2a + Ribavirin

Name: Peg-Interferon Alfa-2a

Description: Syringe, Subcutaneous Injection, 180 μg, Once weekly, 24 or 48 weeks depending on response

Type: Drug

Arm 1: Daclatasvir + Peg-Interferon Alfa-2a + Ribavirin

Name: Ribavirin

Description: Tablet, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 or 48 weeks depending on response

Type: Drug

Arm 1: Daclatasvir + Peg-Interferon Alfa-2a + Ribavirin


Primary Outcomes

Description: SVR12 was defined as Hepatitis C Virus (HCV) RNA levels Measure: Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12)

Time: Post-treatment Week 12

Secondary Outcomes

Description: SVR12 was defined as Hepatitis C Virus (HCV) RNA levels Measure: Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene

Time: Post-treatment Week 12

Description: The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. Data for post-treatment Weeks 36 and 48 were based on participants who had achieved virologic response (defined as HCV RNA levels Measure: Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels Time: Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Week 24


Description: The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.

Measure: Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels Time: Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Weeks 12 and 24

Description: An AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing 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; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. For analysis purpose, participants were assigned to following 4 race/ethnicity cohorts: Black/African American, White/Caucasian, Latino and Non-Latino. Some participants were represented in more than one race/ethnicity cohort.

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

Time: From first dose to last dose plus 7 days (treatment period [TP]) through 48 weeks after the end of TP (follow-up period [FUP])

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 rs12979860

Some participants were represented in more than one race/ethnicity cohort.. Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene.



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