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

NCT ID: NCT01797848

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-11-30

Brief Summary

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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

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Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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pegIFNα 2a + Ribavirin + Placebo

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

Group Type EXPERIMENTAL

Peginterferon alfa 2a

Intervention Type DRUG

Ribavirin

Intervention Type DRUG

Placebo matching Daclatasvir

Intervention Type DRUG

pegIFNα 2a + Ribavirin + 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

Group Type EXPERIMENTAL

Peginterferon alfa 2a

Intervention Type DRUG

Ribavirin

Intervention Type DRUG

Daclatasvir

Intervention Type DRUG

Interventions

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Peginterferon alfa 2a

Intervention Type DRUG

Ribavirin

Intervention Type DRUG

Placebo matching Daclatasvir

Intervention Type DRUG

Daclatasvir

Intervention Type DRUG

Other Intervention Names

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Pegasys® Copegus® (Taiwan, Korea and Singapore) Wei Lining (China) BMS-790052-05

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Countries

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Taiwan

Related Links

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http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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AI444-047

Identifier Type: -

Identifier Source: org_study_id