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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-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: