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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01492426




Registration number
NCT01492426
Ethics application status
Date submitted
13/12/2011
Date registered
15/12/2011
Date last updated
3/06/2016

Titles & IDs
Public title
Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection
Scientific 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
Secondary ID [1] 0 0
2011-004237-14
Secondary ID [2] 0 0
AI444-052
Universal Trial Number (UTN)
Trial acronym
COMMAND-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Daclatasvir
Treatment: Drugs - Telaprevir
Treatment: Drugs - Peginterferon alfa-2a
Treatment: Drugs - Ribavirin

Experimental: Daclatasvir + Peginterferon alfa-2a + Ribavirin -

Experimental: Telaprevir + Peginterferon alfa-2a + Ribavirin -


Treatment: Drugs: Daclatasvir
Film-coated tablet, oral, 60 mg, once daily, 24 weeks

Treatment: Drugs: Telaprevir
Film-coated tablet, oral, 750 mg, 3 times daily

Treatment: Drugs: Peginterferon alfa-2a
Solution for injection, subcutaneous injection, 180 µg, weekly

Treatment: Drugs: Ribavirin
Film-coated tablet, oral, in a body weight stratified dose range of 1000-1200 mg per day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Timepoint [1] 0 0
Week 12 (Follow-up period)
Secondary outcome [1] 0 0
Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4
Timepoint [1] 0 0
Week 4
Secondary outcome [2] 0 0
Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12
Timepoint [2] 0 0
Week 4, Week 12
Secondary outcome [3] 0 0
Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR)
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24)
Timepoint [4] 0 0
Week 24 (Follow-up period)
Secondary outcome [5] 0 0
Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Timepoint [5] 0 0
Week 12 (Follow-up period)

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Evidence of decompensated liver disease

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2014
Sample size
Target
Accrual to date
Final
605
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Camperdown
Recruitment hospital [2] 0 0
Local Institution - Penrith
Recruitment hospital [3] 0 0
Local Institution - Westmead Nsw
Recruitment hospital [4] 0 0
Local Institution - Greenslopes Qld
Recruitment hospital [5] 0 0
Local Institution - Adelaide
Recruitment hospital [6] 0 0
Local Institution - Fitzroy
Recruitment hospital [7] 0 0
Local Institution - Prahran
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2750 - Penrith
Recruitment postcode(s) [3] 0 0
2145 - Westmead Nsw
Recruitment postcode(s) [4] 0 0
4120 - Greenslopes Qld
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3065 VIC - Fitzroy
Recruitment postcode(s) [7] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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United States of America
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Arizona
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California
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United States of America
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Connecticut
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Florida
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United States of America
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Georgia
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Illinois
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Maryland
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Minnesota
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Missouri
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New York
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North Carolina
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Pennsylvania
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Rhode Island
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Texas
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Austria
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Linz
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Austria
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Wien
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Brazil
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Sao Paulo
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Ontario
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Denmark
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Hvidovre
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Denmark
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Odense
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France
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Besancon
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France
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Bondy Cedex
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France
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Grenoble Cedex 09
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France
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Lille Cedex
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France
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Paris Cedex 12
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France
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Paris Cedex 13
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France
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Pessac
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France
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Strasbourg
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Germany
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Berlin
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Germany
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Essen
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Germany
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Frankfurt
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Germany
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Freiburg
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Koeln
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Israel
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Haifa
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Israel
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Nazareth
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Israel
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Tel Aviv
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Israel
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Zefat
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Italy
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Bergamo
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Italy
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Cisanello (pisa)
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Italy
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Firenze
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Italy
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Napoli
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Italy
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Torino
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Bialystok
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Chorzow
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Kielce
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Myslowice
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Raciborz
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Poland
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Wroclaw
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Russian Federation
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Moscow
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Spain
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Alcorcon
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Spain
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Barcelona
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Spain
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Valencia
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Switzerland
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Zurich
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United Kingdom
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Greater London
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United Kingdom
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Scotland
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United Kingdom
State/province [64] 0 0
West Midlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT01492426
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01492426