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

Hepatitis C Clinical Trial

— COMMAND-Asia  

Official title:

A Phase 3 Randomized, Double Blind, Multi-National Evaluation of Daclatasvir in Combination With Peg Interferon Alfa-2a and Ribavirin in Treatment-Naive Subjects With Chronic Hepatitis C Genotypes 1 and 4

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01797848
• Other study ID #: AI444-047
• Status: Withdrawn
• Phase: Phase 3
• First received: February 21, 2013
• Last updated: November 21, 2013
• Start date: June 2014
• Est. completion date: November 2016

Study information

• Verified date: November 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationChina: Ethics CommitteeKorea: Food and Drug AdministrationKorea: Institutional Review BoardSingapore: Health Sciences AuthoritySingapore: Clinical Trials & Epidemiology Research Unit (CTERU)Singapore: Domain Specific Review BoardsTaiwan : Food and Drug AdministrationTaiwan: Institutional Review BoardTaiwan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Drug:
• Peginterferon alfa 2a

• Ribavirin

• Placebo matching Daclatasvir

• Daclatasvir

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Proportion of Genotype (GT) 4 subjects with SVR24		Week 24 post treatment follow up visit	No
Secondary	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)	No
Secondary	Frequency of Serious Adverse Events (SAEs)/discontinuations due to Adverse Events (AEs)		Up to 48 weeks plus 30 days	Yes
Secondary	Discontinuations due to Adverse Events (AEs)		Up to 48 weeks plus 7 days	No
Secondary	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	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form