SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01581203

Developed by Shray Alag, 2019.
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 Hepatitis C
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 74
TTC7A MST1 TRAF3IP2 TPP2 TBX19 IL12A MET IL12RB1 RASGRP1 TCF4 HSD3B7 KRT8 SERPINA1 TCF3 VIPAS39 ATP7A IGF2R MMEL1 ATP7B ALMS1 SPIB KRT18 VPS33B CIITA PDGFRL PIK3CA GPR35 CYP7A1 GUSB PIK3R1 AMACR RFXANK SHPK IGHM PIEZO1 SLC25A15 BTK IL21R CD40LG BLNK GLIS3 APC CLEC7A AIRE LRRC8A CASP8 POU2AF1 XIAP CASP10 C1S CYP7B1 PRKCD CD79A CD79B IRF5 C4B IL17RC IL17RA IGLL1 CTNNB1 FAS SKIV2L FASLG SH2D1A RFX5 IL17F RFXAP TNFSF15 TNPO3 PGM1 STAT1 TP53 AXIN1 FOXP3