search
Back to results

Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection (COMMAND-3)

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Daclatasvir
Telaprevir
Peginterferon alfa-2a
Ribavirin
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C Virus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Participants chronically infected with hepatitis C virus (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
  • No history of cirrhosis liver biopsy within 3 years or Fibroscan® within 1 year
  • Body mass index of 18 to 35 kg/m^2
  • Negative for HIV and hepatitis B virus

Key Exclusion Criteria:

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

Sites / Locations

  • The Kirklin Clinic
  • Mayo Clinic Arizona
  • Va Long Beach Healthcare System
  • Medical Associates Research Group
  • Yale University School Of Medicine
  • Orlando Immunology Center
  • Atlanta Medical Center
  • Gastrointestinal Specialists Of Georgia
  • Northwestern University
  • Rush University Medical Center
  • University Of Maryland
  • Johns Hopkins University
  • Minnesota Gastroenterology, P.A.
  • Saint Louis University Gastroenterology & Hepatology
  • Weill Cornell Medical College
  • University Of North Carolina At Chapel Hill School Of Med
  • Carolinas Medical Center
  • Duke University Medical Center
  • Albert Einstein Medical Center
  • University Gastroenterology
  • The Miriam Hospital
  • Brooke Army Medical Center
  • Baylor College Of Medicine
  • Research Specialists Of Texas
  • Alamo Medical Research
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Daclatasvir + Peginterferon alfa-2a + Ribavirin

Telaprevir + Peginterferon alfa-2a + Ribavirin

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
SVR12 was defined as hepatitis C virus RNA levels to be lower than the limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up Week 12.

Secondary Outcome Measures

Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4
RVR was defined as hepatitis c virus RNA levels lower than lower limit of quantitation, ie, 25 IU/mL target not detected at Week 4 of treatment.
Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12
eRVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at both Weeks 4 and 12 of treatment.
Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR)
cEVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at Week 12 of treatment.
Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24)
SVR24 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 24 of treatment.
Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
SVR12 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 12 of treatment.

Full Information

First Posted
December 13, 2011
Last Updated
April 28, 2016
Sponsor
Bristol-Myers Squibb
search

1. Study Identification

Unique Protocol Identification Number
NCT01492426
Brief Title
Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection
Acronym
COMMAND-3
Official Title
A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared With Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Detailed Description
Allocation: Randomized Stratified

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Hepatitis C Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
605 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daclatasvir + Peginterferon alfa-2a + Ribavirin
Arm Type
Experimental
Arm Title
Telaprevir + Peginterferon alfa-2a + Ribavirin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Daclatasvir
Other Intervention Name(s)
BMS-790052
Intervention Description
Film-coated tablet, oral, 60 mg, once daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
Telaprevir
Other Intervention Name(s)
Incivek®
Intervention Description
Film-coated tablet, oral, 750 mg, 3 times daily
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a
Other Intervention Name(s)
Pegasys®
Intervention Description
Solution for injection, subcutaneous injection, 180 μg, weekly
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Copegus®
Intervention Description
Film-coated tablet, oral, in a body weight stratified dose range of 1000-1200 mg per day
Primary Outcome Measure Information:
Title
Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Description
SVR12 was defined as hepatitis C virus RNA levels to be lower than the limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up Week 12.
Time Frame
Week 12 (Follow-up period)
Secondary Outcome Measure Information:
Title
Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4
Description
RVR was defined as hepatitis c virus RNA levels lower than lower limit of quantitation, ie, 25 IU/mL target not detected at Week 4 of treatment.
Time Frame
Week 4
Title
Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12
Description
eRVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at both Weeks 4 and 12 of treatment.
Time Frame
Week 4, Week 12
Title
Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR)
Description
cEVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at Week 12 of treatment.
Time Frame
Week 12
Title
Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24)
Description
SVR24 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 24 of treatment.
Time Frame
Week 24 (Follow-up period)
Title
Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Description
SVR12 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 12 of treatment.
Time Frame
Week 12 (Follow-up period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Participants chronically infected with hepatitis C virus (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 No history of cirrhosis liver biopsy within 3 years or Fibroscan® within 1 year Body mass index of 18 to 35 kg/m^2 Negative for HIV and hepatitis B virus Key Exclusion Criteria: Evidence of decompensated liver disease Evidence of medical condition other than HCV contributing to chronic liver disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
The Kirklin Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Va Long Beach Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Medical Associates Research Group
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Yale University School Of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8019
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Atlanta Medical Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
Facility Name
Gastrointestinal Specialists Of Georgia
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University Of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1595
Country
United States
Facility Name
Johns Hopkins University
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Minnesota Gastroenterology, P.A.
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
Facility Name
Saint Louis University Gastroenterology & Hepatology
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University Of North Carolina At Chapel Hill School Of Med
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7584
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
University Gastroenterology
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Brooke Army Medical Center
City
Ft. Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Baylor College Of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Specialists Of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Local Institution
City
Ciudad De Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1121ABE
Country
Argentina
Facility Name
Local Institution
City
Ciudad De Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Local Institution
City
Prov. Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1629
Country
Argentina
Facility Name
Local Institution
City
Prov De Santa Fe
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Local Institution
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Local Institution
City
Penrith
State/Province
New South Wales
ZIP/Postal Code
2750
Country
Australia
Facility Name
Local Institution
City
Westmead Nsw
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Local Institution
City
Greenslopes Qld
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Local Institution
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Local Institution
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065 VIC
Country
Australia
Facility Name
Local Institution
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Local Institution
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Local Institution
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
04023-062
Country
Brazil
Facility Name
Local Institution
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Local Institution
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Local Institution
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
Local Institution
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Local Institution
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Local Institution
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Local Institution
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
Local Institution
City
Bondy Cedex
ZIP/Postal Code
93143
Country
France
Facility Name
Local Institution
City
Grenoble Cedex 09
ZIP/Postal Code
38043
Country
France
Facility Name
Local Institution
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution
City
Paris Cedex 12
ZIP/Postal Code
75571
Country
France
Facility Name
Local Institution
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Local Institution
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
Local Institution
City
Strasbourg
ZIP/Postal Code
67090
Country
France
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
10969
Country
Germany
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Local Institution
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Local Institution
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Local Institution
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Local Institution
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Local Institution
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Local Institution
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Local Institution
City
Nazareth
ZIP/Postal Code
16100
Country
Israel
Facility Name
Local Institution
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Local Institution
City
Zefat
ZIP/Postal Code
13110
Country
Israel
Facility Name
Local Institution
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Local Institution
City
Cisanello (pisa)
ZIP/Postal Code
56124
Country
Italy
Facility Name
Local Institution
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Local Institution
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution
City
Torino
ZIP/Postal Code
10100
Country
Italy
Facility Name
Local Institution
City
Bialystok
ZIP/Postal Code
15-540
Country
Poland
Facility Name
Local Institution
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Local Institution
City
Kielce
ZIP/Postal Code
25-317
Country
Poland
Facility Name
Local Institution
City
Myslowice
ZIP/Postal Code
41-400
Country
Poland
Facility Name
Local Institution
City
Raciborz
ZIP/Postal Code
47-400
Country
Poland
Facility Name
Local Institution
City
Wroclaw
ZIP/Postal Code
50-220
Country
Poland
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
109240
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
121170
Country
Russian Federation
Facility Name
Local Institution
City
Alcorcon
ZIP/Postal Code
28922
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Local Institution
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Local Institution
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Local Institution
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Local Institution
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TH
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

Learn more about this trial

Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection

We'll reach out to this number within 24 hrs