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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
Group Labels: 4 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
Group Labels: 4 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
Group Labels: 2 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
Group Labels: 2 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-treatmentSecondary 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 12Measure: 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 cohortMeasure: 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.