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Hepatitis C VirusPhase 2HEPCATNCT01125189

Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients

A Phase 2 study testing Daclatasvir, peg-interferon alfa-2a and ribavirin in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 64 sites in 11 countries.

Completed

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

Official record
Search all trials

Trial summary

To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatitis C Virus
What is being tested?
Daclatasvir, peg-interferon alfa-2a and ribavirin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
558 participants
Where
64 sitesin 11 countries
Study dates
Jul 2010to Aug 2012
Phase
Phase 2
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients chronically infected with hepatitis C virus (HCV) genotype 1 or 4
  • HCV RNA viral load of ≥100,000 IU/mL
  • No previous exposure to interferon, pegIFNα, or RBV
  • Results of a liver biopsy demonstrating absence of cirrhosis obtained ≤24 months prior to randomization. Compensated cirrhotics with Hepatitis C virus genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization)
  • Findings on ultrasound, computed tomography scan, or magnetic resonance imaging 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma
  • Body mass index of 18 to 35 kg/m^2

Who cannot join

  • Positive for hepatitis B or HIV-1/HIV-2 antibody at screening
  • Evidence of a medical condition associated with chronic liver disease other than HCV
  • Evidence of decompensated cirrhosis based on radiologic criteria or biopsy

Trial locations and contacts

64 sites in 11 countries.

64 sites in 11 countries

United States33 sites

  • North Texas Research Institute

    Arlington, Texas, 76012

  • Transplant Center And Hepatology Clinic, B-154

    Aurora, Colorado, 80045

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Digestive Disease Associates, P.A.

    Baltimore, Maryland, 21229

  • University Of North Carolina At Chapel Hill School Of Med

    Chapel Hill, North Carolina, 27599

  • Metropolitan Research

    Fairfax, Virginia, 22031

  • University Of Florida Hepatology

    Gainesville, Florida, 32610

  • James Sungsik Park, M.D. C.N.S.C.

    Great Neck, New York, 11201

  • St. Luke'S Episcopal Hospital - Baylor College Of Medicine

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • Scripps Clinic

    La Jolla, California, 92037

  • Cli

    Los Angeles, California, 90048

  • Johns Hopkins University

    Lutherville, Maryland, 21093

  • Dean Clinic

    Madison, Wisconsin, 53715

  • University Of Miami

    Miami, Florida, 33136

  • Alabama Liver & Digestive Specialists (Alds)

    Montgomery, Alabama, 36116

  • Upper Delaware Valley Infectious Diseases, Pc

    Monticello, New York, 12701

  • Nashville Medical Research Institute

    Nashville, Tennessee, 37205

  • Yale University School Of Medicine

    New Haven, Connecticut, 06520

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • University Of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University Gastroenterology

    Providence, Rhode Island, 02905

  • Alamo Medical Research

    San Antonio, Texas, 78215

  • Desta Digestive Disease Medical Center

    San Diego, California, 92114

  • University Of California, San Francisco/Sf General Hospital

    San Francisco, California, 94110

  • California Pacific Medical Center

    San Francisco, California, 94115

  • Kaiser Permanente Medical Center

    San Francisco, California, 94118

  • Miami Research Associates

    South Miami, Florida, 33143

  • Claudia T. Martorell, Md, Llc

    Springfield, Massachusetts, 01105

  • Carolinas Center For Liver Disease

    Statesville, North Carolina, 28677

  • James J Peters Vamc

    The Bronx, New York, 10468

  • Options Health Research, Llc

    Tulsa, Oklahoma, 74104

  • Healthcare Research Consultants

    Tulsa, Oklahoma, 74135

Other trials in United States

Australia6 sites

  • Local Institution

    Adelaide, South Australia, 5000

  • Local Institution

    Camperdown, NSW 2050

  • Local Institution

    Clayton Vic, Victoria, 3168

  • Local Institution

    Darlinghurst, New South Wales, 2010

  • Local Institution

    Westmead Nsw, New South Wales, 2145

  • Local Institution

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada5 sites

  • Local Institution

    Edmonton, Alberta, T6G 2B7

  • Local institution

    Toronto, Ontario, M5G 2N2

  • Local Institution

    Toronto, Ontario, M5T 2S8

  • Local Institution

    Vancouver, British Columbia, V6Z 2K5

  • Local Institution

    Victoria, British Columbia, V8V 3P9

Other trials in Canada

France5 sites

  • Local Institution

    Créteil, 94000

  • Local Institution

    Marseille, 13285

  • Local Institution

    Montpellier, 34295

  • Local Instituition

    Paris, 75571

  • Local Institution

    Paris, 75679

Other trials in France

Germany4 sites

  • Local Institution

    Düsseldorf, 40237

  • Local Institution

    Essen, 45122

  • Local Institution

    Frankfurt, 60590

  • Local Institution

    Hamburg, 20099

Other trials in Germany

Denmark3 sites

  • Local Institution

    Aarhus, 8200

  • Local Institution

    Hvidovre, 2650

  • Local Institution

    Odense, 5000

Other trials in Denmark

Egypt2 sites

  • Local Institution

    Cairo, 11559

  • Local Institution

    Shebin Elkom, Monufia Governorate, 35111

Other trials in Egypt

Italy2 sites

  • Local Institution

    Cisanello (pisa), 56124

  • Local Institution

    Pavia, 27100

Other trials in Italy

Sweden2 sites

  • Local Institution

    Gothenburg, SE-416 85

  • Local Institution

    Stockholm, 141 86

Other trials in Sweden

Mexico1 site

  • Local Institution

    Guadalajara, Jalisco, 44340

Other trials in Mexico

Puerto Rico1 site

  • Local Institution

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: A Phase 2b Study of Daclatasvir in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 1 and 4 Infection

To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.

Being tested
Daclatasvir, Placebo, peg-interferon alfa-2a, ribavirin
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

    Tablets, oral, 20 mg, once daily, 12-24 weeks, depending on response

  • DaclatasvirDrug

    Tablets, oral, 60 mg, once daily, 12-24 weeks, depending on response

  • PlaceboDrug

    Tablets, oral, 0 mg, once daily, 24 weeks

  • peg-interferon alfa-2aDrug

    Also called Pegasys

    Syringe, subcutaneous Injection, 180 µg, once weekly, 24 or 48 weeks depending on response

  • ribavirinDrug

    Also called Copegus

    Tablets, oral, 1000 or 1200 mg based on weight, once daily, 24 or 48 weeks depending on response

Study groups in NCT01125189
Study groupRoleWhat they receive
Daclatasvir plus peg-interferon alfa-2a and ribavirin (20 mg)ExperimentalNot described
Receives: Drug: Daclatasvir; Drug: peg-interferon alfa-2a; Drug: ribavirin
Daclatasvir plus peg-interferon alfa-2a and ribavirin (60 mg)ExperimentalNot described
Receives: Drug: Daclatasvir; Drug: peg-interferon alfa-2a; Drug: ribavirin
Placebo plus peg-interferon alfa-2a and ribavirinPlacebo comparatorNot described
Receives: Drug: Placebo; Drug: peg-interferon alfa-2a; Drug: ribavirin

What is being measured

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

  1. Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR)

    eRVR was defined as HCV RNA <lower limit of quantitation and target not detected at both Weeks 4 and 12 on treatment.

    Measured: Weeks 4 and 12

  2. Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24)

    SVR24 was defined as HCV <lower limit of quantitation (LLOQ) and target not detected (TND) at follow-up Week 24. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

    Measured: Follow-up Week 24

  3. Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died

    SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.

    Measured: From start of study treatment (day 1) up to follow-up Week 48

Secondary outcomes (4)

  1. Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Rapid Virologic Response (RVR)

    RVR was defined as undetectable RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 4. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.

    Measured: Week 4

  2. Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Complete Early Virologic Response (cEVR)

    cEVR was defined as undetectable RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.

    Measured: Week 12

  3. Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With 12-week Sustained Virologic Response (SVR12)

    SVR12 was defined as undetectable RNA (HCV RNA < lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.

    Measured: Follow-up Week 12

  4. Percentage of Resistant Variants Associated With Virologic Failure

    Virologic failure was defined as:

    1. Virologic breakthrough: confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA <LLOQ, target not detected (TND) while on treatment
    2. <1 log10 decrease in HCV RNA from baseline at Week 4 of treatment
    3. Failure to achieve early virologic response: <2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment
    4. HCV RNA < LLOQ, TD or ≥ LLOQ at Week 12 and ≥ LLOQ at Week 24
    5. HCV RNA ≥LLOQ or <LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)
    6. Relapse, defined as HCV RNA ≥LLOQ or <LLOQ, TD during follow-up, after HCV RNA < LLOQ, TND at EOT.

    The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.

    Measured: Follow-up Week 48

Timeline

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

  1. First posted18 May 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionApr 2012
  4. Study completionAug 2012

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
558 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01125189
Sponsor's protocol ID
AI444-010
Other IDs
2010-018295-24
Acronym
HEPCAT
Status last verified
Sep 2015
First submitted
17 May 2010
Last updated
23 Oct 2015
Data monitoring committee
No

Publications

  • Hezode C, Hirschfield GM, Ghesquiere W, Sievert W, Rodriguez-Torres M, Shafran SD, Thuluvath PJ, Tatum HA, Waked I, Esmat G, Lawitz EJ, Rustgi VK, Pol S, Weis N, Pockros PJ, Bourliere M, Serfaty L, Vierling JM, Fried MW, Weiland O, Brunetto MR, Everson GT, Zeuzem S, Kwo PY, Sulkowski M, Brau N, Hernandez D, McPhee F, Wind-Rotolo M, Liu Z, Noviello S, Hughes EA, Yin PD, Schnittman S. Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection: a randomised study. Gut. 2015 Jun;64(6):948-56. doi: 10.1136/gutjnl-2014-307498. Epub 2014 Jul 30.

    PubMed 25080450

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Daclatasvir, peg-interferon alfa-2a and ribavirin in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 64 sites in 11 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 3 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 23 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States, Australia, Canada, France, Germany and 6 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 23 Oct 2015). 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 Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR) (time frame: Weeks 4 and 12). The study lists 3 primary outcomes in all. 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 NCT01125189, which also lists 1 linked publication.

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 23 Oct 2015.

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