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Report for Clinical Trial NCT01581203

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 3 Study With Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-Naive Subjects With Chronic Hepatitis C Genotype 1b Infection

The purpose of this study is to estimate efficacy, as determined by the proportion of subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at post-treatment Week 12, for subjects who are prior null or partial responders to P/R or who are treatment-naive.

NCT01581203 Hepatitis C Virus
MeSH: Hepatitis C Hepatitis
HPO: Hepatitis

4 Interventions

Name: Asunaprevir (ASV)

Type: Drug

Arm 1: Null or Partial Responder to P/R (ASV + DCV) Arm 2: Intolerant to or Ineligible for P/R (ASV + DCV) Arm 3: Treatment naive (ASV + DCV) Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week

Name: Daclatasvir (DCV)

Type: Drug

Arm 1: Null or Partial Responder to P/R (ASV + DCV) Arm 2: Intolerant to or Ineligible for P/R (ASV + DCV) Arm 3: Treatment naive (ASV + DCV) Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week

Name: Pegylated-interferon alfa 2a (PegIFN)

Type: Drug

Arm 3: Treatment naive (ASV + DCV) Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week

Name: Ribavirin (RBV)

Type: Drug

Arm 3: Treatment naive (ASV + DCV) Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week


Primary Outcomes

Measure: Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post treatment Week 12, for subjects who are prior null or partial responders to P/R or are treatment-naive

Time: At 12 weeks post-treatment

Secondary Outcomes

Measure: Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for subjects who are intolerant or ineligible to P/R

Time: Post-treatment Week 12

Measure: On treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs)

Time: End of Treatment (up to 48 weeks) plus 7 days

Measure: Differences in rates of selected grade 3-4 laboratory abnormalities during the first 12 weeks between treatments (ASV + DCV vs PBO) for naive subjects

Time: Up to first 12 weeks

Measure: Proportion of genotype 1b subjects with SVR12 (HCV RNA < LOQ at post treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28B gene for each cohort

Time: Post-treatment Week 12

Description: eRVR = Extended rapid virologic response, EOT = End of treatment

Measure: Proportion of genotype 1b subjects with HCV RNA undetectable

Time: At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 12, or post-treatment Week 24 for each cohort

Measure: Proportion of genotypes 1b subjects with HCV RNA < LOQ

Time: At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [VR(4&12)]; EOT (up to 24 weeks), post-treatment Week 24 (SVR24) for each cohort

Measure: Proportion of subjects with anemia

Time: At 12 weeks post-treatment

Measure: Proportion of subjects with rash

Time: At 12 weeks post-treatment

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 rs12979860

Proportion of genotype 1b subjects with SVR12 (HCV RNA < LOQ at post treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28B gene for each cohort.



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