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

NCT01797848 | Withdrawn Phase 3

• 1 other identifier: AI444-047
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Discontinuations due to Adverse Events (AEs)

  Up to 48 weeks plus 7 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

Study Arms (2)

pegIFNα 2a + Ribavirin + Placebo

EXPERIMENTAL

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

Drug: Peginterferon alfa 2a; Drug: Ribavirin; Drug: Placebo matching Daclatasvir

pegIFNα 2a + Ribavirin + Daclatasvir

EXPERIMENTAL

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

Drug: Peginterferon alfa 2a; Drug: Ribavirin; Drug: Daclatasvir

Interventions

Peginterferon alfa 2a DRUG

Also known as: Pegasys®

pegIFNα 2a + Ribavirin + Daclatasvir; pegIFNα 2a + Ribavirin + Placebo

Ribavirin DRUG

Also known as: Copegus® (Taiwan, Korea and Singapore), Wei Lining (China)

pegIFNα 2a + Ribavirin + Daclatasvir; pegIFNα 2a + Ribavirin + Placebo

Placebo matching Daclatasvir DRUG

pegIFNα 2a + Ribavirin + Placebo

Daclatasvir DRUG

Also known as: BMS-790052-05

pegIFNα 2a + Ribavirin + Daclatasvir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis C

Interventions

peginterferon alfa-2a; Ribavirin; daclatasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2013
• First Posted: February 25, 2013
• Study Start: June 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 25, 2013

Record last verified: 2013-11