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Hepatitis C VirusPhase 2NCT01030432

Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin

A Phase 2 study testing BMS-650032, Peginterferon Alfa-2a and Ribavirin in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 40 sites in 8 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 identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4). 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?
BMS-650032, Peginterferon Alfa-2a and Ribavirin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
285 participants
Where
40 sitesin 8 countries
Study dates
Feb 2010to Oct 2012
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Subjects chronically infected with HCV genotype 1 (Phase 2a and Phase 2b)
  • Subjects chronically infected with HCV genotype 4 (Phase 2b only)
  • HCV RNA viral load of ≥ 10*5* IU/mL at screening
  • BMI of 18 - 35 kg/m² at screening

Who cannot join

  • Cirrhosis (Phase 2a only)
  • Decompensated cirrhosis (Phase 2b)
  • Co-infection with HBV or HIV
  • Hepatocellular carcinoma
  • Prior treatment with anti-HCV drugs

Trial locations and contacts

40 sites in 8 countries.

40 sites in 8 countries

United States14 sites

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • University Of Alabama At Birmingham

    Birmingham, Alabama, 35294-0006

  • University Of North Carolina, Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Metropolitan Research

    Fairfax, Virginia, 22031

  • Gastro One

    Germantown, Tennessee, 38138

  • Dean Clinic

    Madison, Wisconsin, 53715

  • Alabama Liver & Digestive Specialists (Alds)

    Montgomery, Alabama, 36116

  • Florida Hospital Transplant Center

    Orlando, Florida, 32804

  • Hospital Of The University Of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Oregon Health Science Univ

    Portland, Oregon, 97239

  • The Research Institute

    Springfield, Massachusetts, 01105

  • James J Peters Vamc

    The Bronx, New York, 10468

  • Healthcare Research Consultants

    Tulsa, Oklahoma, 74135-2920

  • Umass Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

France6 sites

  • Local Institution

    Créteil, 94010

  • Local Institution

    Marseille, 13285

  • Local Instituition

    Montpellier, 34295

  • Local Institution

    Paris, 75651

  • Local Institution

    Paris, 75679

  • Local Institution

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Spain5 sites

  • Local Institution

    Alicante, 03010

  • Local Institution

    Barcelona, 08035

  • Local Institution

    Madrid, 28222

  • Local Institution

    Málaga, 29010

  • Local Institution

    Valencia, 46010

Other trials in Spain

United Kingdom5 sites

  • Local Institution

    Glasgow, Lanarkshire, G12 0YN

  • Local Institution

    London, Greater London, E1 2AT

  • Local Institution

    London, Greater London, SE5 9RS

  • Local Institution

    London, Greater London, W2 1NY

  • Local Institution

    Manchester, Greater Manchester, M8 5RB

Other trials in United Kingdom

Argentina4 sites

  • Local Institution

    Buenos Aires, Buenos Aires, C1181

  • Local Institution

    Ciudad de Buenos Aires, Buenos Aires, C1121ABE

  • Local Institution

    Prov de Santa Fe, Santa Fe Province, 2000

  • Local Institution

    Prov. Buenos Aires, Buenos Aires, 1629

Other trials in Argentina

Germany4 sites

  • Local Institution

    Frankfurt, 60590

  • Local Institution

    Heidelberg, 69120

  • Local Institution

    Mainz, 55131

  • Local Institution

    Würzburg, 97080

Other trials in Germany

Ireland1 site

  • Local Institution

    Dublin, Dublin, DUBLIN 7

Other trials in Ireland

Italy1 site

  • Local Institution

    Torino, 10126

Other trials in Italy

About this study

Official title: A Phase 2a/2b Study of BMS-650032 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotypes 1 and 4 Chronic Hepatitis C Infection

The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).

Being tested
BMS-650032, Placebo, Peginterferon 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.

  • BMS-650032Drug

    Tablets, Oral, 200 mg, Twice Daily, 48 weeks

  • BMS-650032Drug

    Tablets, Oral, 200 mg, Twice Daily, 12 or 24 weeks, depending on response

  • PlaceboDrug

    Also called Pegasys

    Tablets, Oral, 0 mg, twice daily, 48 weeks

  • PlaceboDrug

    Tablets, Oral, 0 mg, twice daily, 0 or 12 weeks (depending on response) beginning at Week 12

  • PlaceboDrug

    Tablets, Oral, 0 mg, twice daily 24 weeks

  • Peginterferon Alfa-2aDrug

    Also called Pegasys

    Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks

  • Peginterferon Alfa-2aDrug

    Also called Pegasys

    Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 24 or 48 weeks, depending on response

  • RibavirinDrug

    Also called Copegus

    Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks

  • RibavirinDrug

    Also called Pegasys

    Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 24 or 48 weeks depending on response

Study groups in NCT01030432
Study groupRoleWhat they receive
Phase 2a: Arm 1ExperimentalNot described
Receives: Drug: BMS-650032; Drug: Peginterferon Alfa-2a; Drug: Ribavirin
Phase 2a: Arm 2Placebo comparatorNot described
Receives: Drug: Placebo; Drug: Peginterferon Alfa-2a; Drug: Ribavirin
Phase 2b: Arm 1ExperimentalNot described
Receives: Drug: BMS-650032; Drug: Placebo; Drug: Peginterferon Alfa-2a; Drug: Ribavirin
Phase 2b: Arm 2Placebo comparatorNot described
Receives: Drug: Placebo; Drug: Peginterferon Alfa-2a; Drug: Ribavirin

What is being measured

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

  1. Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs

    Measured: 12 weeks after first dose

  2. Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA

    Measured: Week 4

  3. Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA

    Measured: Week 12

  4. Phase 2b only: Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA

    Measured: at follow-up Week 24

Secondary outcomes (6)

  1. Proportion of HCV genotype 1 subjects with rapid virologic response (RVR), defined as undetectable HCV RNA at Week 4

    Measured: Week 4

  2. Proportion of HCV genotype 1 subjects with complete early rapid virologic response (eEVR), defined as undetectable HCV RNA at Week 12 (Stage 2 only)

    Measured: at Week 12 (Stage 2 only)

  3. Proportion of HCV genotype 1 subjects with early virologic response (EVR) defined as ≥2 log10 decrease in HCV RNA from baseline at Week 12 (Stage 1 only)

    Measured: Week 12 (Stage 1 only)

  4. Proportion of HCV genotype 1 subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA at follow-up Week 12

    Measured: follow-up Week 12

  5. Proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24) defined as undetectable HCV RNA at follow-up Week 24 (Stage 1 only)

    Measured: follow-up Week 24 (Stage 1 only)

  6. Resistant variants associated with virologic failure

    Measured: 48 weeks after last dose

Timeline

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

  1. First posted11 Dec 2009 (estimated)
  2. Study startFeb 2010
  3. Primary completionOct 2012
  4. Study completionOct 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
285 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01030432
Sponsor's protocol ID
AI447-016
Other IDs
2009-013652-69, 2009
Status last verified
Sep 2015
First submitted
10 Dec 2009
Last updated
9 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • Bronowicki JP, Ratziu V, Gadano A, Thuluvath PJ, Bessone F, Martorell CT, Pol S, Terg R, Younes Z, He B, Eley T, Cohen D, Yu F, Hernandez D, McPhee F, Mendez P, Hughes E. Randomized trial of asunaprevir plus peginterferon alfa and ribavirin for previously untreated genotype 1 or 4 chronic hepatitis C. J Hepatol. 2014 Dec;61(6):1220-7. doi: 10.1016/j.jhep.2014.07.011. Epub 2014 Jul 16.

    PubMed 25038486

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMS-650032, Peginterferon Alfa-2a and Ribavirin in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 40 sites in 8 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 4 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 9 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 40 sites in United States, France, Spain, United Kingdom, Argentina and 3 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs (time frame: 12 weeks after first dose). The study lists 4 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 NCT01030432, 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 9 Oct 2015.

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