Study comparing BMS-790052 (daclatasvir) to telaprevir combined with peginterferon-alfa-2a and ribavirin in untreated hepatitis C patients

A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared with Telaprevir in Combination with Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Patients with Chronic Hepatitis-C Revised Protocol 02 incorporating protocol amendment 03 (version 1.0 dated 22-Jan-13). + Pharmacogenetics Blood Sample Amendment 01 (version 1.0 dated 23-Nov-11) + Administrative Letter 01 Site Specific dated 27-Mar-2012 - COMMAND-3

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004237-14-GB

Enrollment

900

Registered

2012-02-14

Start date

2012-03-14

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C MedDRA version: 14.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: BMS-790052 Product Code: BMS-790052 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: daclatasvir Current Spons

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Subjects chronically infected with HCV genotype 1a or 1b -HCV RNA viral load =10,000 IU/mL - No prior treatment including but not limited to interferon, ribavirin and direct-acting antivirals - if no prior history of cirrhosis liver biopsy within 3 years or Fibroscan® within 1 year -Body Mass Index (BMI) of 18 to 35 kg/m2 -Negative for HIV and Hepatitis B Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 810 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90

Exclusion criteria

Exclusion criteria: - Evidence of decompensated liver disease - Evidence of medical condition contributing to chronic liver disease other than HCV

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this study is to compare the effectiveness of BMS-790052 (daclatasvir) and telaprevir when given in combination with peginterferon-alfa 2a and ribavirin in genotype 1b patients; Secondary Objective: Proportion of genotype1 b patients with : 1) hemoglobin value less than 10 g/dL 2) rash events 3) HCV RNA undetectable Week 12 4) HCV RNA undetectable Week 4 5) HCV RNA undetectable Weeks 4 & 12 6) SVR24 7) SVR12 based on IL28B genotype 8) genotype1a patients with SVR12 ;Primary end point(s): Proportion of genotype 1b patients with SVR12, defined as HCV RNA less than limit of quantitation at follow-up Week 12 in each group;Timepoint(s) of evaluation of this end point: Follow-up Week 12	—

Measure

Time frame

Main Objective: The purpose of this study is to compare the effectiveness of BMS-790052 (daclatasvir) and telaprevir when given in combination with peginterferon-alfa 2a and ribavirin in genotype 1b patients; Secondary Objective: Proportion of genotype1 b patients with : 1) hemoglobin value less than 10 g/dL 2) rash events 3) HCV RNA undetectable Week 12 4) HCV RNA undetectable Week 4 5) HCV RNA undetectable Weeks 4 & 12 6) SVR24 7) SVR12 based on IL28B genotype 8) genotype1a patients with SVR12 ;Primary end point(s): Proportion of genotype 1b patients with SVR12, defined as HCV RNA less than limit of quantitation at follow-up Week 12 in each group;Timepoint(s) of evaluation of this end point: Follow-up Week 12

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Secondary

Measure	Time frame
Secondary end point(s): Proportion of genotype1 b patients with 1) hemoglobin value less than 10 g/dL 2) rash events 3) HCV RNA undetectable Week 12 4) HCV RNA undetectable Week 4 5) HCV RNA undetectable Weeks 4 & 12 6) SVR24 7) SVR12 based on IL28B genotype 8) genotype1a patients with SVR12 ; Timepoint(s) of evaluation of this end point: 1) Up to Week 12 2) Up to Week 12 3) Week 12 4) Week 4 5) Week 4 and 12 6) Follow-up Week 24 7) Follow-up Week 12 8) Follow-up Week 12	—

Measure

Time frame

Secondary end point(s): Proportion of genotype1 b patients with 1) hemoglobin value less than 10 g/dL 2) rash events 3) HCV RNA undetectable Week 12 4) HCV RNA undetectable Week 4 5) HCV RNA undetectable Weeks 4 & 12 6) SVR24 7) SVR12 based on IL28B genotype 8) genotype1a patients with SVR12 ; Timepoint(s) of evaluation of this end point: 1) Up to Week 12 2) Up to Week 12 3) Week 12 4) Week 4 5) Week 4 and 12 6) Follow-up Week 24 7) Follow-up Week 12 8) Follow-up Week 12

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Countries

Argentina, Australia, Austria, Brazil, Canada, Denmark, France, Germany, Israel, Italy, Poland, Russian Federation, Spain, Switzerland, United Kingdom, United States

Contacts

Public ContactEU Study Start-Up Unit

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026