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Report for Clinical Trial NCT01973049

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Subjects With Genotype 1 Chronic Hepatitis C and Compensated Cirrhosis

To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.

NCT01973049 Hepatitis C
MeSH:Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis
HPO:Hepatitis

5 Interventions

Name: Daclatasvir

Type: Drug
Group Labels: 4

A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive) A2: DCV/ASV/BMS-791325 + RBV (naive) A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced) A4: DCV/ASV/BMS-791325 + RBV (experienced)

Name: Asunaprevir

Type: Drug
Group Labels: 4

A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive) A2: DCV/ASV/BMS-791325 + RBV (naive) A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced) A4: DCV/ASV/BMS-791325 + RBV (experienced)

Name: BMS-791325

Type: Drug
Group Labels: 5

A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive) A2: DCV/ASV/BMS-791325 + RBV (naive) A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced) A4: DCV/ASV/BM A4: DCV/ASV/BMS-791325 + RBV (experienced)

Name: Ribavirin

Type: Drug
Group Labels: 2

A2: DCV/ASV/BMS-791325 + RBV (naive) A4: DCV/ASV/BMS-791325 + RBV (experienced)

Name: Placebo matching Ribavirin

Type: Drug
Group Labels: 2

A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive) A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced)


Primary Outcomes

Description: SVR12 is defined as Hepatitis C virus ribonucleic acid (HCV RNA) < Limit of Quantification (LOQ) target detected or target not detected (LOQ TD/TND)

Measure: Proportion of treated subjects in each of the naive arms with sustained virologic response (SVR12)

Time: Post treatment 12 week

Secondary Outcomes

Measure: Proportion of treated subjects in each of the experienced arms with SVR12

Time: Post treatment 12 Week

Measure: Proportion of subjects in each arm who achieve HCV RNA < LOQ TD/TND

Time: Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)

Measure: Proportion of subjects in each arm who achieve HCV RNA < LOQ TND

Time: Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8), 12 (SVR12) and 24 (SVR24)

Measure: Safety as measured by frequency of Serious Adverse Events(SAEs)and discontinuations due to Adverse Events(AEs)

Time: Up to end of treatment (week 12) + 7 days

Measure: Proportion of subjects with anemia defined as Hg < 10 g/dL on-treatment and Hg ≥ 10 g/dL at baseline in each arm within each cohort

Time: Up to end of treatment (week 12) + 7 days

Measure: Differences in rates of selected Grade 3 - 4 laboratory test result abnormalities

Time: Up to end of treatment (week 12) + 7 days

Measure: Proportion of subjects achieving SVR12 associated with HCV geno subtype 1a vs 1b

Time: Post treatment 12 Week

Measure: Proportion of subjects in each arm achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism(SNP) status (CC genotype or non-CC genotype)

Time: Post treatment 12 Week

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 rs12979860

Proportion of subjects in each arm achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism(SNP) status (CC genotype or non-CC genotype).



HPO Nodes


HPO: