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CompletedNCT01492426COMMAND-3Updated Jun 3, 2016Results posted

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 interventional study of Daclatasvir and Telaprevir in Hepatitis C, sponsored by Bristol-Myers Squibb. Completed at 91 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-03.

Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
605
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 the detailed description

Allocation: Randomized Stratified

02

Conditions studied

  • Hepatitis C

Keywords

  • Hepatitis C Virus
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 605 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
605 participants (actual)

Study arms

  • Experimental
    Daclatasvir + Peginterferon alfa-2a + Ribavirin

    Drug: Daclatasvir · Drug: Peginterferon alfa-2a · Drug: Ribavirin

  • Experimental
    Telaprevir + Peginterferon alfa-2a + Ribavirin

    Drug: Telaprevir · Drug: Peginterferon alfa-2a · Drug: Ribavirin

Interventions

  • DrugDaclatasvir

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

    Also known as: BMS-790052

  • DrugTelaprevir

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

    Also known as: Incivek®

  • DrugPeginterferon alfa-2a

    Solution for injection, subcutaneous injection, 180 μg, weekly

    Also known as: Pegasys®

  • DrugRibavirin

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

    Also known as: Copegus®

06

What researchers measure

Primary outcomes

  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.

    Time frame: Week 12 (Follow-up period)

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Week 12 (Follow-up period)

07

Results

Posted Jun 3, 2016

Participant flow

A total of 793 participants were recruited at 90 sites in 15 countries.

Treatment
Participant flow — Treatment
MilestoneDaclatasvir + PEG-IFN Alpha-2a + RibavirinTelaprevir + PEG-IFN Alpha-2a + Ribavirin
Started402200
Completed319160
Not completed8340
Withdrew: Death01
Withdrew: Other10
Withdrew: Adverse event2525
Withdrew: Lack of efficacy385
Withdrew: Participant withdrew consent12
Withdrew: Poor compliance/noncompliance10
Withdrew: Subject requested discontinue study drug73
Withdrew: Lost to follow-up94
Withdrew: Participant does not meet study criteria10
Follow-Up
Participant flow — Follow-Up
MilestoneDaclatasvir + PEG-IFN Alpha-2a + RibavirinTelaprevir + PEG-IFN Alpha-2a + Ribavirin
Started384191
Completed359181
Not completed2510
Withdrew: Protocol requires no follow-up21
Withdrew: Death10
Withdrew: Other42
Withdrew: Participant withdrew consent61
Withdrew: Lost to follow-up126

Outcome measures

PrimaryPercentage 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.

Time frame:
Week 12 (Follow-up period)
Reported as:
Number · Percentage of participants
Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Percentage of participantsDaclatasvir + PEG-IFN Alpha-2a + RibavirinTelaprevir + PEG-IFN Alpha-2a + Ribavirin
Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)85.1 (80.2 to 89.1)81.3 (73.7 to 87.5)
Statistical analysis
  • Daclatasvir + PEG-IFN Alpha-2a + Ribavirin vs Telaprevir + PEG-IFN Alpha-2a + Ribavirin · Stratum-adjusted Mantel-Haenszel · Percentage difference: 4.3 · 95% CI -3.3 to 11.9
SecondaryPercentage 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.

Time frame:
Week 4
Reported as:
Number · Percentage of participants
Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4
Percentage of participantsDaclatasvir + PEG-IFN Alpha-2a + RibavirinTelaprevir + PEG-IFN Alpha-2a + Ribavirin
Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 477.2 (71.7 to 82.1)79.1 (71.2 to 85.6)
SecondaryPercentage 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.

Time frame:
Week 4, Week 12
Reported as:
Number · Percentage of participants
Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12
Percentage of participantsDaclatasvir + PEG-IFN Alpha-2a + RibavirinTelaprevir + PEG-IFN Alpha-2a + Ribavirin
Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 1275.0 (69.4 to 80.1)73.1 (64.8 to 80.4)
SecondaryPercentage 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.

Time frame:
Week 12
Reported as:
Number · percentage of participants
Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR)
percentage of participantsDaclatasvir + PEG-IFN Alpha-2a+ RibavirinTelaprevir + PEG-IFN Alpha-2a + Ribavirin
Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR)90.7 (86.5 to 93.9)90.03 (84.0 to 94.7)
SecondaryPercentage 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.

Time frame:
Week 24 (Follow-up period)
Reported as:
Number · Percentage of participants
Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24)
Percentage of participantsDaclatasvir + PEG-IFN Alpha-2a+ RibavirinTelaprevir + PEG-IFN Alpha-2a + Ribavirin
Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24)84.3 (79.4 to 88.5)80.6 (72.9 to 86.9)
SecondaryPercentage 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.

Time frame:
Week 12 (Follow-up period)
Reported as:
Number · Percentage of participants
Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Percentage of participantsDaclatasvir + PEG-IFN Alpha-2a + RibavirinTelaprevir + PEG-IFN Alpha-2a + Ribavirin
Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)64.9 (56.2 to 73.0)69.7 (57.1 to 80.4)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Daclatasvir + PEG-IFN Alpha-2a + Ribavirin—26/402 (6.5%)384/402 (95.5%)
Telaprevir + PEG-IFN Alpha-2a + Ribavirin—20/200 (10%)193/200 (96.5%)
Most frequent serious events
Showing 10 of 53
Most frequent serious events
EventDaclatasvir + PEG-IFN Alpha-2a + RibavirinTelaprevir + PEG-IFN Alpha-2a + Ribavirin
AnaemiaBlood and lymphatic system disorders0/4025/200
Renal failure acuteRenal and urinary disorders0/4022/200
DepressionPsychiatric disorders0/4022/200
PneumoniaInfections and infestations3/4020/200
PalpitationsCardiac disorders0/4021/200
BronchopneumoniaInfections and infestations0/4021/200
HypokalaemiaMetabolism and nutrition disorders1/4021/200
Psychotic disorderPsychiatric disorders0/4021/200
Proctitis infectiousInfections and infestations0/4021/200
VomitingGastrointestinal disorders0/4021/200
Most frequent other events
Showing 10 of 42
Most frequent other events
EventDaclatasvir + PEG-IFN Alpha-2a + RibavirinTelaprevir + PEG-IFN Alpha-2a + Ribavirin
AnaemiaBlood and lymphatic system disorders96/40298/200
FatigueGeneral disorders140/40281/200
PruritusSkin and subcutaneous tissue disorders107/40275/200
NauseaGastrointestinal disorders88/40274/200
RashSkin and subcutaneous tissue disorders93/40269/200
HeadacheNervous system disorders137/40257/200
AstheniaGeneral disorders109/40253/200
NeutropeniaBlood and lymphatic system disorders87/40227/200
AlopeciaSkin and subcutaneous tissue disorders86/40232/200
Influenza like illnessGeneral disorders85/40238/200

Baseline characteristics

Age, Continuous
Age, Continuous(years)Daclatasvir + PEG-IFN Alpha-2a + RibavirinTelaprevir + PEG-IFN Alpha-2a + RibavirinTotal
Mean46.5 ± 12.1247.6 ± 12.2946.9 ± 12.18
Age, Customized
Age, Customized(participants)Daclatasvir + PEG-IFN Alpha-2a + RibavirinTelaprevir + PEG-IFN Alpha-2a + RibavirinTotal
Younger than 65 years387188575
65 years and older151227
Sex: Female, Male
Sex: Female, Male(Participants)Daclatasvir + PEG-IFN Alpha-2a + RibavirinTelaprevir + PEG-IFN Alpha-2a + RibavirinTotal
Female14581226
Male257119376
08

Study locations

91 sites
  • The Kirklin Clinic
    Birmingham, Alabama 35294, United States
  • Mayo Clinic Arizona
    Phoenix, Arizona 85054, United States
  • Va Long Beach Healthcare System
    Long Beach, California 90822, United States
  • Medical Associates Research Group
    San Diego, California 92123, United States
  • Yale University School Of Medicine
    New Haven, Connecticut 06520-8019, United States
  • Orlando Immunology Center
    Orlando, Florida 32803, United States
  • Atlanta Medical Center
    Atlanta, Georgia 30312, United States
  • Gastrointestinal Specialists Of Georgia
    Marietta, Georgia 30060, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • University Of Maryland
    Baltimore, Maryland 21201-1595, United States
  • Johns Hopkins University
    Lutherville, Maryland 21093, United States
  • Minnesota Gastroenterology, P.A.
    Saint Paul, Minnesota 55114, United States
  • Saint Louis University Gastroenterology & Hepatology
    St. Louis, Missouri 63104, United States
  • Weill Cornell Medical College
    New York, New York 10021, United States
  • University Of North Carolina At Chapel Hill School Of Med
    Chapel Hill, North Carolina 27599-7584, United States
  • Carolinas Medical Center
    Charlotte, North Carolina 28203, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • Albert Einstein Medical Center
    Philadelphia, Pennsylvania 19141, United States
  • University Gastroenterology
    Providence, Rhode Island 02905, United States
  • The Miriam Hospital
    Providence, Rhode Island 02906, United States
  • Brooke Army Medical Center
    Ft. Sam Houston, Texas 78234, United States
  • Baylor College Of Medicine
    Houston, Texas 77030, United States
  • Research Specialists Of Texas
    Houston, Texas 77030, United States
  • Alamo Medical Research
    San Antonio, Texas 78215, United States
  • Local Institution
    Ciudad De Buenos Aires, Buenos Aires C1121ABE, Argentina
  • Local Institution
    Ciudad De Buenos Aires, Buenos Aires C1181ACH, Argentina
  • Local Institution
    Prov. Buenos Aires, Buenos Aires 1629, Argentina
  • Local Institution
    Prov De Santa Fe, Santa Fe 2000, Argentina
  • Local Institution
    Camperdown, New South Wales 2050, Australia
  • Local Institution
    Penrith, New South Wales 2750, Australia
  • Local Institution
    Westmead Nsw, New South Wales 2145, Australia
  • Local Institution
    Greenslopes Qld, Queensland 4120, Australia
  • Local Institution
    Adelaide, South Australia 5000, Australia
  • Local Institution
    Fitzroy, Victoria 3065 VIC, Australia
  • Local Institution
    Prahran, Victoria 3181, Australia
  • Local Institution
    Linz, 4010, Austria
  • Local Institution
    Wien, 1090, Austria
  • Local Institution
    Wien, 1160, Austria
  • Local Institution
    Sao Paulo, 04023-062, Brazil
  • Local Institution
    Calgary, Alberta T2N 4Z6, Canada
  • Local Institution
    Edmonton, Alberta T6G 2B7, Canada
  • Local Institution
    Vancouver, British Columbia V6Z 2K5, Canada
  • Local Institution
    Winnipeg, Manitoba R3E 3P4, Canada
  • Local Institution
    Ottawa, Ontario K1H 8L6, Canada
  • Local Institution
    Toronto, Ontario M5G 2N2, Canada
  • Local Institution
    Hvidovre, 2650, Denmark
  • Local Institution
    Odense, 5000, Denmark
  • Local Institution
    Besancon, 25000, France
  • Local Institution
    Bondy Cedex, 93143, France
  • Local Institution
    Grenoble Cedex 09, 38043, France
  • Local Institution
    Lille Cedex, 59037, France
  • Local Institution
    Paris Cedex 12, 75571, France
  • Local Institution
    Paris Cedex 13, 75651, France
  • Local Institution
    Pessac, 33600, France
  • Local Institution
    Strasbourg, 67090, France
  • Local Institution
    Berlin, 10969, Germany
  • Local Institution
    Berlin, 13353, Germany
  • Local Institution
    Essen, 45122, Germany
  • Local Institution
    Frankfurt, 60590, Germany
  • Local Institution
    Freiburg, 79106, Germany
  • Local Institution
    Hamburg, 20246, Germany
  • Local Institution
    Hannover, 30625, Germany
  • Local Institution
    Koeln, 50937, Germany
  • Local Institution
    Haifa, 31096, Israel
  • Local Institution
    Nazareth, 16100, Israel
  • Local Institution
    Tel Aviv, 64239, Israel
  • Local Institution
    Zefat, 13110, Israel
  • Local Institution
    Bergamo, 24127, Italy
  • Local Institution
    Cisanello (pisa), 56124, Italy
  • Local Institution
    Firenze, 50134, Italy
  • Local Institution
    Napoli, 80131, Italy
  • Local Institution
    Torino, 10100, Italy
  • Local Institution
    Bialystok, 15-540, Poland
  • Local Institution
    Chorzow, 41-500, Poland
  • Local Institution
    Kielce, 25-317, Poland
  • Local Institution
    Myslowice, 41-400, Poland
  • Local Institution
    Raciborz, 47-400, Poland
  • Local Institution
    Wroclaw, 50-220, Poland
  • Local Institution
    Moscow, 109240, Russian Federation
  • Local Institution
    Moscow, 119991, Russian Federation
  • Local Institution
    Moscow, 121170, Russian Federation
  • Local Institution
    Alcorcon, 28922, Spain
  • Local Institution
    Barcelona, 08003, Spain
  • Local Institution
    Barcelona, 08036, Spain
  • Local Institution
    Valencia, 46010, Spain
  • Local Institution
    Zurich, 8091, Switzerland
  • Local Institution
    London, Greater London SE5 9RS, United Kingdom
  • Local Institution
    Edinburgh, Scotland EH4 2XU, United Kingdom
  • Local Institution
    Glasgow, Scotland G12 0YN, United Kingdom
  • Local Institution
    Birmingham, West Midlands B15 2TH, United Kingdom
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01492426
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Dec 15, 2011
Start date
Jan 2012
Primary completion
Dec 2013
Completion
Mar 2014
Results posted
Jun 3, 2016
Last update
Jun 3, 2016

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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