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Hepatitis C Virus InfectionPhase 2NCT01428063

Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials

A Phase 2 study testing Daclatasvir, Asunaprevir and Pegylated interferon alfa-2a in people with Hepatitis C Virus Infection, run by Bristol-Myers Squibb at 106 sites in 19 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

The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and determine whether addition of these drugs results in higher cure rates in patients who previously failed therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C Virus Infection
What is being tested?
Daclatasvir, Asunaprevir and Pegylated interferon alfa-2a
Could I receive a placebo?
No, everyone receives an active treatment
How many people
276 participants
Where
106 sitesin 19 countries
Study dates
Sep 2011to Dec 2014
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Prior participation in any BMS-790052, BMS-650032, or BMS-791325 trial and assigned to control arm (pegIFNα-2a/ribavirin + placebo) during the trial
  • Hepatitis C virus (HCV) genotype 1, 2, 3, or 4 (mixed genotypes are not permitted)
  • HCV RNA viral load detectable

Who cannot join

  • Discontinuation from a prior BMS HCV clinical trial due to a pegIFNα-2a/ribavirin-related event
  • Any anti-HCV therapy following initial treatment with BMS-650032, BMS-790052, or BMS-791325
  • Positive for hepatitis B infection (hepatitis B surface antigen) or HIV-1 or HIV-2 antibody at screening
  • Evidence of medical condition associated with chronic liver disease other than HCV infection
  • Evidence of decompensated cirrhosis based on radiologic criteria or biopsy

Trial locations and contacts

106 sites in 19 countries.

106 sites in 19 countries

United States20 sites

  • University Of Colorado Denver And Hospital

    Aurora, Colorado, 80045

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Digestive Disease Associates, P.A.

    Catonsville, Maryland, 21228

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Metropolitan Research

    Fairfax, Virginia, 22031

  • Uf Hepatology Research At Ctrb

    Gainesville, Florida, 32610

  • Baylor College Of Medicine

    Houston, Texas, 77030

  • Scripps Clinic

    La Jolla, California, 92037

  • Scpmg/ Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Dean Clinic

    Madison, Wisconsin, 53715

  • North Shore Long Island Jewish Health System

    Manhasset, New York, 11030

  • Schiff Center For Liver Diseases

    Miami, Florida, 33136

  • Baptist Medical Center South

    Montgomery, Alabama, 36116

  • Nashville Medical Research Institute

    Nashville, Tennessee, 37205

  • Yale University School Of Medicine

    New Haven, Connecticut, 06520

  • University Of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Alamo Medical Research

    San Antonio, Texas, 78215

  • Washington University School Of Medicine

    St Louis, Missouri, 63110

  • Options Health Research, Llc

    Tulsa, Oklahoma, 74104

Other trials in United States

France15 sites

  • Local Institution

    Bondy, 93143

  • Local Institution

    Clichy, 92118

  • Local Institution

    Créteil, 94000

  • Local Institution

    Créteil, 94010

  • Local Institution

    Lille, 59037

  • Local Institution

    Lyon, 69288

  • Local Institution

    Marseille, 13285

  • Local Institution

    Montpellier, 34295

  • Local Institution

    Nice, 06202

  • Local Institution

    Paris, 75571

  • Local Institution

    Paris, 75651

  • Local Institution

    Paris, 75679

  • Local Institution

    Toulouse, 31059

  • Local Institution

    Vandœuvre-lès-Nancy, 54511

  • Local Institution

    Villejuif, 94804

Other trials in France

Australia10 sites

  • Local Institution

    Adelaide, South Australia, 5000

  • Local Institution

    Clayton Vic, Victoria, 3168

  • Local Institution

    Darlinghurst, New South Wales, 2010

  • Local Institution

    Fitzroy, Victoria, 3065 VIC

  • Local Institution

    Fremantle, Western Australia, 6160

  • Local Institution

    Heidelberg, Victoria, 3084

  • Local Institution

    Kogarah, New South Wales, 2218

  • Local Institution

    Melbourne, Victoria, 3004

  • Local Institution

    Perth, Western Australia, 6001

  • Local Institution

    Westmead Nsw, New South Wales, 2145

Other trials in Australia

Canada9 sites

  • Local Institution

    Montreal, Quebec, H2L 4P9

  • Local Institution

    Montreal, Quebec, H3T 1E2

  • Local Institution

    Québec, Quebec, G3K 2P8

  • Local Institution

    Toronto, Ontario, M5G 2N2

  • Local Institution

    Toronto, Ontario, M5T 2S8

  • Local Institution

    Toronto, Ontario, M6H 3M1

  • Local Institution

    Vancouver, British Columbia, V6Z 2K5

  • Local Institution

    Vaughan, Ontario, L4L 4Y7

  • Local Institution

    Victoria, British Columbia, V8V 3P9

Other trials in Canada

Italy9 sites

  • Local Institution

    Brescia, 25123

  • Local Institution

    Cisanello (pisa), 56124

  • Local Institution

    Messina, 98124

  • Local Institution

    Milan, 20121

  • Local Institution

    Pavia, 27100

  • Local Institution

    Roma, 00149

  • Local Institution

    Roma, 00161

  • Local Institution

    Torino, 10126

  • Local Institution

    Viale Del Policlinico, 155, 00161

Other trials in Italy

South Korea8 sites

  • Local Institution

    Busan, 602-715

  • Local Institution

    Busan, 602-739

  • Local Institution

    Busan, 614-735

  • Local Institution

    Daegu, 700-721

  • Local Institution

    Daegu, 705-703

  • Local Institution

    Gyeonggi-do, 420-767

  • Local Institution

    Seoul, 120-752

  • Local Institution

    Seoul, 138-736

Other trials in South Korea

Germany7 sites

  • Local Institution

    Berlin, 12157

  • Local Institution

    Berlin, 13353

  • Local Institution

    Bonn, 53105

  • Local Institution

    Frankfurt, 60590

  • Local Institution

    Hamburg, 20246

  • Local Institution

    Hanover, 30625

  • Local Institution

    Heidelberg, 69120

Other trials in Germany

United Kingdom6 sites

  • Local Institution

    Glasgow, Lanarkshire, G12 0YN

  • Local Institution

    London, Greater London, NW3 2QG,

  • Local Institution

    London, Greater London, SE5 9RS

  • Local Institution

    London, Greater London, SW17 0QT

  • Local Institution

    London, Greater London, W2 1NY

  • Local Institution

    Manchester, Greater Manchester, M8 5RB

Other trials in United Kingdom

Argentina5 sites

  • Local Institution

    Buenos Aires, Buenos Aires, 1119

  • 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

Taiwan4 sites

  • Local Institution

    Taichung, 402

  • Local Institution

    Taichung, 40447

  • Local Institution

    Taipei, 100

  • Local Institution

    Taipei, 112

Other trials in Taiwan

Austria2 sites

  • Local Institution

    Graz, 8036

  • Local Institution

    Vienna, 1090

Other trials in Austria

Ireland2 sites

  • Local Institution

    Dublin, Dublin, DUBLIN 7

  • Local Institution

    Dublin, Dublin

Other trials in Ireland

Poland2 sites

  • Local Institution

    Bialystok, 15-540

  • Local Institution

    Wroclaw, 50-349

Other trials in Poland

Sweden2 sites

  • Local Institution

    Gothenburg, SE-416 85

  • Local Institution

    Stockholm, 141 86

Other trials in Sweden

Denmark1 site

  • Local Institution

    Hvidovre, 2650

Other trials in Denmark

Greece1 site

  • Local Institution

    Thesaloniki, 54639

Other trials in Greece

Mexico1 site

  • Local Institution

    Guadalajara, Jalisco, 44160

Other trials in Mexico

New Zealand1 site

  • Local Institution

    Auckland, 92024

Other trials in New Zealand

Spain1 site

  • Local Institution

    Barcelona, 08036

Other trials in Spain

About this study

Official title: An Open-Label Re-Treatment Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C

The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and determine whether addition of these drugs results in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS study NCT01428063 (AI447-028) will receive active drugs in this study.

Read the detailed description
  • Intervention Model:
  • Parallel: for all patients entering the trial
  • Cross-over: for genotype 1b patients rolling over from NCT01428063 (AI447-028) who require rescue therapy after initial treatment in this study
  • Peginterferon alfa-2a
  • Ribavirin
  • Daclatasvir
  • Asunaprevir
Being tested
Daclatasvir, Asunaprevir, Pegylated 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

    Also called BMS-790052

  • AsunaprevirDrug

    Also called BMS-650032

  • Pegylated interferon alfa-2aDrug

    Also called pegIFNα-2a, Pegasys®

  • RibavirinDrug

    Also called Copegus®

Study groups in NCT01428063
Study groupRoleWhat they receive
Daclatasvir + Asunaprevir + PegIFNα-2a + RibavirinExperimentalPatients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
Receives: Drug: Daclatasvir; Drug: Asunaprevir; Drug: Pegylated interferon alfa-2a; Drug: Ribavirin
Daclatasvir + PegIFNα-2a + RibavirinExperimentalPatients received daclatasvir, (two 30-mg tablets or one 60-mg tablet, by mouth once daily) + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
Receives: Drug: Daclatasvir; Drug: Pegylated interferon alfa-2a; Drug: Ribavirin
Daclatasvir + AsunaprevirExperimentalPatients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks
Receives: Drug: Daclatasvir; Drug: Asunaprevir

What is being measured

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

  1. Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV)

    SVR12 defined as HCV RNA<limit of quantitation at follow-up Week 12. Nonresponder (NR)=prior NR to pegIFN-2a or ribavirin.

    Measured: Week 12 (Follow-up period)

Secondary outcomes (7)

  1. Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12)

    SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.

    Measured: Week 12 (Follow-up period)

  2. Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4

    RVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at Week 4.

    Measured: Week 4

  3. Percentage of Participants With Extended Rapid Virologic Response (eRVR)

    eRVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at both weeks 4 and 12.

    Measured: Week 4 and 12

  4. Percentage of Participants With Complete Early Virologic Response (cEVR)

    cEVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at week 12.

    Measured: Week 12

  5. Percentage of Participants With End of the Treatment Response (EOTR)

    EOTR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at end of treatment.

    Measured: End of the study (Week 24)

  6. Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)

    SVR24 was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24.

    Measured: Week 24 (Follow-up)

  7. Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study

    AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. 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: For AEs: Day 1 until last visit. For SAEs: Day 1 until 30 days post discontinuation of dosing or participation

Timeline

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

  1. First posted2 Sep 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionSep 2014
  4. Study completionDec 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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01428063
Sponsor's protocol ID
AI444-026
Other IDs
2011-000836-27
Status last verified
Apr 2016
First submitted
1 Sep 2011
Last updated
27 May 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Daclatasvir, Asunaprevir and Pegylated interferon alfa-2a in people with Hepatitis C Virus Infection, run by Bristol-Myers Squibb at 106 sites in 19 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 3 inclusion and 5 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 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States, France, Australia, Canada, Italy and 14 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 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 27 May 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 Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV) (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 NCT01428063.

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 27 May 2016.

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