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Hepatitis CPhase 3COMMAND-3NCT01492426

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

A Phase 3 study testing Daclatasvir, Telaprevir and Peginterferon alfa-2a in people with Hepatitis C, run by Bristol-Myers Squibb at 91 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C
What is being tested?
Daclatasvir, Telaprevir and Peginterferon alfa-2a
Could I receive a placebo?
No, everyone receives an active treatment
How many people
605 participants
Where
91 sitesin 16 countries
Study dates
Jan 2012to Mar 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

91 sites in 16 countries.

91 sites in 16 countries

United States25 sites

  • Atlanta Medical Center

    Atlanta, Georgia, 30312

  • University Of Maryland

    Baltimore, Maryland, 21201-1595

  • The Kirklin Clinic

    Birmingham, Alabama, 35294

  • University Of North Carolina At Chapel Hill School Of Med

    Chapel Hill, North Carolina, 27599-7584

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Baylor College Of Medicine

    Houston, Texas, 77030

  • Research Specialists Of Texas

    Houston, Texas, 77030

  • Va Long Beach Healthcare System

    Long Beach, California, 90822

  • Johns Hopkins University

    Lutherville, Maryland, 21093

  • Gastrointestinal Specialists Of Georgia

    Marietta, Georgia, 30060

  • Yale University School Of Medicine

    New Haven, Connecticut, 06520-8019

  • Weill Cornell Medical College

    New York, New York, 10021

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • University Gastroenterology

    Providence, Rhode Island, 02905

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • Minnesota Gastroenterology, P.A.

    Saint Paul, Minnesota, 55114

  • Alamo Medical Research

    San Antonio, Texas, 78215

  • Medical Associates Research Group

    San Diego, California, 92123

  • Saint Louis University Gastroenterology & Hepatology

    St Louis, Missouri, 63104

Other trials in United States

France8 sites

  • Local Institution

    Besançon, 25000

  • Local Institution

    Bondy, 93143

  • Local Institution

    Grenoble, 38043

  • Local Institution

    Lille, 59037

  • Local Institution

    Paris, 75571

  • Local Institution

    Paris, 75651

  • Local Institution

    Pessac, 33600

  • Local Institution

    Strasbourg, 67090

Other trials in France

Germany8 sites

  • Local Institution

    Berlin, 10969

  • Local Institution

    Berlin, 13353

  • Local Institution

    Cologne, 50937

  • Local Institution

    Essen, 45122

  • Local Institution

    Frankfurt, 60590

  • Local Institution

    Freiburg im Breisgau, 79106

  • Local Institution

    Hamburg, 20246

  • Local Institution

    Hanover, 30625

Other trials in Germany

Australia7 sites

  • Local Institution

    Adelaide, South Australia, 5000

  • Local Institution

    Camperdown, New South Wales, 2050

  • Local Institution

    Fitzroy, Victoria, 3065 VIC

  • Local Institution

    Greenslopes Qld, Queensland, 4120

  • Local Institution

    Penrith, New South Wales, 2750

  • Local Institution

    Prahran, Victoria, 3181

  • Local Institution

    Westmead Nsw, New South Wales, 2145

Other trials in Australia

Canada6 sites

  • Local Institution

    Calgary, Alberta, T2N 4Z6

  • Local Institution

    Edmonton, Alberta, T6G 2B7

  • Local Institution

    Ottawa, Ontario, K1H 8L6

  • Local Institution

    Toronto, Ontario, M5G 2N2

  • Local Institution

    Vancouver, British Columbia, V6Z 2K5

  • Local Institution

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Poland6 sites

  • Local Institution

    Bialystok, 15-540

  • Local Institution

    Chorzów, 41-500

  • Local Institution

    Kielce, 25-317

  • Local Institution

    Mysłowice, 41-400

  • Local Institution

    Racibórz, 47-400

  • Local Institution

    Wroclaw, 50-220

Other trials in Poland

Italy5 sites

  • Local Institution

    Bergamo, 24127

  • Local Institution

    Cisanello (pisa), 56124

  • Local Institution

    Florence, 50134

  • Local Institution

    Naples, 80131

  • Local Institution

    Torino, 10100

Other trials in Italy

Argentina4 sites

  • Local Institution

    Ciudad de Buenos Aires, Buenos Aires, C1121ABE

  • Local Institution

    Ciudad de Buenos Aires, Buenos Aires, C1181ACH

  • Local Institution

    Prov de Santa Fe, Santa Fe Province, 2000

  • Local Institution

    Prov. Buenos Aires, Buenos Aires, 1629

Other trials in Argentina

Israel4 sites

  • Local Institution

    Haifa, 31096

  • Local Institution

    Nazareth, 16100

  • Local Institution

    Safed, 13110

  • Local Institution

    Tel Aviv, 64239

Other trials in Israel

Spain4 sites

  • Local Institution

    Alcorcón, 28922

  • Local Institution

    Barcelona, 08003

  • Local Institution

    Barcelona, 08036

  • Local Institution

    Valencia, 46010

Other trials in Spain

United Kingdom4 sites

  • Local Institution

    Birmingham, West Midlands, B15 2TH

  • Local Institution

    Edinburgh, Scotland, EH4 2XU

  • Local Institution

    Glasgow, Scotland, G12 0YN

  • Local Institution

    London, Greater London, SE5 9RS

Other trials in United Kingdom

Austria3 sites

  • Local Institution

    Linz, 4010

  • Local Institution

    Vienna, 1090

  • Local Institution

    Vienna, 1160

Other trials in Austria

Russia3 sites

  • Local Institution

    Moscow, 109240

  • Local Institution

    Moscow, 119991

  • Local Institution

    Moscow, 121170

Other trials in Russia

Denmark2 sites

  • Local Institution

    Hvidovre, 2650

  • Local Institution

    Odense, 5000

Other trials in Denmark

Brazil1 site

  • Local Institution

    São Paulo, São Paulo, 04023-062

Other trials in Brazil

Switzerland1 site

  • Local Institution

    Zurich, 8091

Other trials in Switzerland

About this study

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

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

Read the detailed description

Allocation: Randomized Stratified

Conditions
Hepatitis C
Being tested
Daclatasvir, Telaprevir, Peginterferon alfa-2a, Ribavirin
Keywords
Hepatitis C Virus
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DaclatasvirDrug

    Also called BMS-790052

    Film-coated tablet, oral, 60 mg, once daily, 24 weeks

  • TelaprevirDrug

    Also called Incivek®

    Film-coated tablet, oral, 750 mg, 3 times daily

  • Peginterferon alfa-2aDrug

    Also called Pegasys®

    Solution for injection, subcutaneous injection, 180 μg, weekly

  • RibavirinDrug

    Also called Copegus®

    Film-coated tablet, oral, in a body weight stratified dose range of 1000-1200 mg per day

Study groups in NCT01492426
Study groupRoleWhat they receive
Daclatasvir + Peginterferon alfa-2a + RibavirinExperimentalNot described
Receives: Drug: Daclatasvir; Drug: Peginterferon alfa-2a; Drug: Ribavirin
Telaprevir + Peginterferon alfa-2a + RibavirinExperimentalNot described
Receives: Drug: Telaprevir; Drug: Peginterferon alfa-2a; Drug: Ribavirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 12 (Follow-up period)

Secondary outcomes (5)

  1. 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.

    Measured: Week 4

  2. 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.

    Measured: Week 4, Week 12

  3. 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.

    Measured: Week 12

  4. 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.

    Measured: Week 24 (Follow-up period)

  5. 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.

    Measured: Week 12 (Follow-up period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionDec 2013
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
605 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01492426
Sponsor's protocol ID
AI444-052
Other IDs
2011-004237-14
Acronym
COMMAND-3
Status last verified
Apr 2016
First submitted
13 Dec 2011
Last updated
3 Jun 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Daclatasvir, Telaprevir and Peginterferon alfa-2a in people with Hepatitis C, run by Bristol-Myers Squibb at 91 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States, France, Germany, Australia, Canada and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) (time frame: Week 12 (Follow-up period)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01492426.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2016.

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