Efficacy and Safety Evaluation of a Treatment Consisting of Peg Interferon Alfa + Ribavirin + Daclatasvir in HCV Genotype 1 and 4 Treatment naïve Patients

Phase 3

Withdrawn

• Conditions: Hepatitis C
• Interventions: Drug: Peginterferon alfa 2a; Drug: Ribavirin; Drug: Placebo matching Daclatasvir; Drug: Daclatasvir

• Registration Number: NCT01797848
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to determine whether 24 week treatment with the Daclatasvir (DCV) in combination with Pegylated-interferon alfa 2a (pegIFNα-2a) and Ribavirin (RBV) is safe and demonstrates rate of Sustained Virologic Response at follow up week 24 (SVR24) (defined as undetectable HCV RNA at post-treatment Week 24) that are non-inferior to 48 weeks of the dual combination therapy of pegIFNα-2a/RBV in a majority of study subjects

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-21
• Study First Submitted QC: 2013-02-21
• Study First Posted: 2013-02-25
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-21
• Last Update Posted: 2013-11-25
• Study Start: 2014-06
• Primary Completion: 2016-11
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients chronically infected with Hepatitis C virus (HCV) GT 1 or 4
• HCV RNA viral load ≥ 10,000 IU/mL
• Naïve to prior treatment with any interferon formulation, Ribavirin (RBV) or HCV direct antiviral agent
• Patients with compensated cirrhosis are permitted

Exclusion Criteria

• Infected with HCV other than GT 1 or 4

• Evidence of decompensated liver disease

• Documented or suspected Hepatocellular carcinoma (HCC) as evidenced by previously obtained imaging studies or liver biopsy

• Evidence of a medical condition contributing to chronic liver disease other than HCV

• History of chronic Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV)

• Current or know history of cancer (except in situ carcinoma of cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment

• Laboratory values:

  1. Hemoglobin < 12 g/dL (females) or < 13 g/dL (males)
  2. Platelets < 90 x 1000000000 cells/L
  3. Absolute neutrophil count (ANC) < 1.5 × 1000000000 cells/L
  4. Total bilirubin ≥ 34 µmol/L (unless due to Gilbert's disease)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pegIFNα 2a + Ribavirin + Daclatasvir	Peginterferon alfa 2a	pegIFNα 2a 180 µg, Solution for injection, Subcutaneous, Once weekly, 24 or 48 weeks depending on response Ribavirin 1000-1200 mg Tablets, by mouth, 400-600mg AM, 600 mg PM, 24 or 48 weeks depending on response Daclatasvir 60 mg Tablets, by mouth, Once daily, 24 weeks
pegIFNα 2a + Ribavirin + Placebo	Peginterferon alfa 2a	pegIFNα 2a 180 µg, Solution for injection, Subcutaneous, Once weekly, 48 weeks Ribavirin 200 mg Tablets, by mouth, 400-600mg AM, 600 mg PM, 48 weeks Placebo 0 mg Tablets, by mouth, Once daily, 24 weeks
pegIFNα 2a + Ribavirin + Placebo	Placebo matching Daclatasvir	pegIFNα 2a 180 µg, Solution for injection, Subcutaneous, Once weekly, 48 weeks Ribavirin 200 mg Tablets, by mouth, 400-600mg AM, 600 mg PM, 48 weeks Placebo 0 mg Tablets, by mouth, Once daily, 24 weeks
pegIFNα 2a + Ribavirin + Placebo	Ribavirin	pegIFNα 2a 180 µg, Solution for injection, Subcutaneous, Once weekly, 48 weeks Ribavirin 200 mg Tablets, by mouth, 400-600mg AM, 600 mg PM, 48 weeks Placebo 0 mg Tablets, by mouth, Once daily, 24 weeks
pegIFNα 2a + Ribavirin + Daclatasvir	Ribavirin	pegIFNα 2a 180 µg, Solution for injection, Subcutaneous, Once weekly, 24 or 48 weeks depending on response Ribavirin 1000-1200 mg Tablets, by mouth, 400-600mg AM, 600 mg PM, 24 or 48 weeks depending on response Daclatasvir 60 mg Tablets, by mouth, Once daily, 24 weeks
pegIFNα 2a + Ribavirin + Daclatasvir	Daclatasvir	pegIFNα 2a 180 µg, Solution for injection, Subcutaneous, Once weekly, 24 or 48 weeks depending on response Ribavirin 1000-1200 mg Tablets, by mouth, 400-600mg AM, 600 mg PM, 24 or 48 weeks depending on response Daclatasvir 60 mg Tablets, by mouth, Once daily, 24 weeks

Primary Outcome Measures

Name	Time	Method
Proportion of Genotype 1 subjects with SVR24, defined as HCV RNA < Limit of quantification (LOQ) at follow-up Week 24 for each cohort	Week 24 post treatment follow up

Secondary Outcome Measures

Name	Time	Method
Discontinuations due to Adverse Events (AEs)	Up to 48 weeks plus 7 days
Proportion of Genotype (GT) 4 subjects with SVR24	Week 24 post treatment follow up visit
Proportion of GT 1 & 4 subjects who achieve HCV RNA < LOQ or undetectable	Week 24 post treatment follow up visit and Week 48 post treatment follow up visit for subjects who achieve Virologic response [VR] (4&12)
Frequency of Serious Adverse Events (SAEs)/discontinuations due to Adverse Events (AEs)	Up to 48 weeks plus 30 days
Proportion of subjects with Sustained Virologic Response at follow up week 12 (SVR12) or SVR24 by rs12979860 Single nucleotide polymorphism (SNP) in the IL28B gene	Up to 72 weeks