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Chronic Hepatitis CPhase 2NCT01012895

Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care

A Phase 2 study testing BMS-790052, BMS-650032 and Pegylated-interferon alfa-2a in people with Chronic Hepatitis C, run by Bristol-Myers Squibb at 18 sites in 3 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 determine whether BMS-650032 and BMS-790052 in combination alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in the treatment of Hepatitis C in patients who have not responded to prior therapy. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Hepatitis C
What is being tested?
BMS-790052, BMS-650032 and Pegylated-interferon alfa-2a
Could I receive a placebo?
No, everyone receives an active treatment
How many people
215 participants
Where
18 sitesin 3 countries
Study dates
Dec 2009to Feb 2014
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

  • Male and female subjects ages 18 to 70 years
  • HCV-Infected Genotype 1 Null responders to current standard of care
  • Expansion Cohorts A1 and A2 are restricted to patients infected with HCV Genotype 1b only.

Who cannot join

  • Evidence of a medical condition associate with chronic liver disease other than HCV
  • History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis
  • History of Cancer within 5 years of enrollment
  • History of gastrointestinal disease or surgical procedure (except Cholecystectomy)
  • History of clinically significant cardiac disease
  • History of Glucose-6-phosphate dehydrogenase (G6PD) deficiency
Show all 9Show fewer
  • Documented cirrhosis within 12 months prior to dosing
  • Positive for Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)
  • Pregnant

Trial locations and contacts

18 sites in 3 countries.

18 sites in 3 countries

United States10 sites

  • Advanced Clinical Research Institute

    Anaheim, California, 92801

  • University Of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Texas Clinical Research Institute, Llc

    Arlington, Texas, 76012

  • University Of Colorado Denver & Hospital

    Aurora, Colorado, 80045

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Southern California Liver Centers

    Coronado, California, 92118

  • Metropolitan Research

    Fairfax, Virginia, 22031

  • Alamo Medical Research

    San Antonio, Texas, 78215

  • San Jose Gastroenterology

    San Jose, California, 95128

  • Carolinas Center For Liver Disease

    Statesville, North Carolina, 28677

Other trials in United States

France7 sites

  • Local Institution

    Clichy, 92118

  • Local Institution

    Créteil, 94010

  • Local Institution

    Marseille, 13285

  • Local Institution

    Paris, 75571

  • Local Institution

    Paris, 75651

  • Local Institution

    Paris, 75679

  • Local Institution

    Pessac, 33604

Other trials in France

Puerto Rico1 site

  • Local Institution

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: Parallel, Open-Label, Randomized, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-790052 and BMS-650032 in Combination in Null Responders to Standard of Care Infected With Chronic Hepatitis C Virus Genotype 1

The purpose of this study is to determine whether BMS-650032 and BMS-790052 in combination alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in the treatment of Hepatitis C in patients who have not responded to prior therapy.

Being tested
BMS-790052, BMS-650032, Pegylated-interferon alfa-2a, Ribavirin
Medical subject headings
Hepatitis C, Chronic

What participants receive

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

  • BMS-790052Drug

    Tablets, Oral, 60 mg, once daily, 24 weeks

  • BMS-650032Drug

    Tablets, Oral, 600 mg, twice daily, 24 weeks

  • BMS-650032Drug

    Tablets, Oral, 200mg, twice daily, 24 weeks

  • BMS-650032Drug

    Tablets, Oral, 200 mg, once daily, 24 weeks

  • Pegylated-interferon alfa-2aDrug

    Also called Pegasys

    Syringe, Subcutaneous Injection, 180 µg, once weekly

  • RibavirinDrug

    Also called Copegus

    Tablets, Oral

    For subjects weighing < 75 kg: 1000 mg; For subjects weighing ≥ 75 kg: 1200 mg

    Twice daily (< 75 kg: 400 mg in ante meridian (AM) and 600 mg in post meridian (PM); ≥ 75 kg: 600 mg in AM and PM), 24 weeks

Study groups in NCT01012895
Study groupRoleWhat they receive
Arm 1: Sentinel AExperimentalBMS-790052 (60mg) once daily + BMS-650032 (600 mg) twice daily
Receives: Drug: BMS-790052; Drug: BMS-650032
Arm 2: Sentinel BExperimentalBMS-790052 (60mg) once daily + BMS-650032 (600mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin
Receives: Drug: BMS-790052; Drug: BMS-650032; Drug: Pegylated-interferon alfa-2a; Drug: Ribavirin
Arm 3: Expansion A1ExperimentalBMS-790052 (60mg) once daily + BMS-650032 (200mg) twice daily
Receives: Drug: BMS-790052; Drug: BMS-650032
Arm 4: Expansion A2ExperimentalBMS-790052 (60mg) once daily + BMS-650032 (200mg) once daily
Receives: Drug: BMS-790052; Drug: BMS-650032
Arm 5: Expansion B1ExperimentalBMS-790052 (60mg) once daily + BMS-650032 (200 mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin
Receives: Drug: BMS-790052; Drug: BMS-650032; Drug: Pegylated-interferon alfa-2a; Drug: Ribavirin
Arm 6: Expansion B2ExperimentalBMS-790052 (60mg) once daily + BMS-650032 (200 mg) once daily + Pegylated-interferon alfa-2a + Ribavirin
Receives: Drug: BMS-790052; Drug: BMS-650032; Drug: Pegylated-interferon alfa-2a; Drug: Ribavirin
Arm 7: Expansion B3ExperimentalBMS-790052 (60 mg) once daily + BMS-650032 (200 mg) twice daily + Ribavirin
Receives: Drug: BMS-790052; Drug: BMS-650032; Drug: Ribavirin

What is being measured

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

  1. Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in subjects' blood before, during and after treatment

    Measured: 12 weeks post treatment

Secondary outcomes (5)

  1. Safety assessments will be based on medical review of the frequency of SAEs and AEs, discontinuations due to AEs, and abnormalities observed from vital sign and ECG measurements, physical examinations and clinical laboratory results

    Serious Adverse Events (SAEs), Adverse Events (AEs), Electrocardiogram (ECG)

    Measured: 12 weeks post-treatment

  2. Pharmacokinetic parameter maximum observed concentration [Cmax] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected.

    Measured: Day 1 and Day 14

  3. Pharmacokinetic parameter trough observed concentration [Cmin] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected.

    Measured: Days 1, Days 7, Days 14, Weeks 4, Weeks 8, Weeks 12, Weeks 16

  4. Pharmacokinetic parameter time of maximum observed concentration [Tmax] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected.

    Measured: Day 1 and Day 14

  5. Pharmacokinetic parameter area under the concentration-time curve in one dosing interval [AUC(TAU)] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected.

    Measured: Day 1 and Day 14

Timeline

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

  1. First posted13 Nov 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionOct 2012
  4. Study completionFeb 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01012895
Sponsor's protocol ID
AI447-011
Other IDs
2010-024637-23
Status last verified
Sep 2015
First submitted
12 Nov 2009
Last updated
9 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • Kao JH, Jensen DM, Manns MP, Jacobson I, Kumada H, Toyota J, Heo J, Yoffe B, Sievert W, Bessone F, Peng CY, Roberts SK, Lee YJ, Bhore R, Mendez P, Hughes E, Noviello S. Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis. Liver Int. 2016 Jul;36(7):954-62. doi: 10.1111/liv.13049. Epub 2016 Jan 24.

    PubMed 26683763

  • McPhee F, Hernandez D, Yu F, Ueland J, Monikowski A, Carifa A, Falk P, Wang C, Fridell R, Eley T, Zhou N, Gardiner D. Resistance analysis of hepatitis C virus genotype 1 prior treatment null responders receiving daclatasvir and asunaprevir. Hepatology. 2013 Sep;58(3):902-11. doi: 10.1002/hep.26388. Epub 2013 Jul 16.

    PubMed 23504694

  • Lok AS, Gardiner DF, Lawitz E, Martorell C, Everson GT, Ghalib R, Reindollar R, Rustgi V, McPhee F, Wind-Rotolo M, Persson A, Zhu K, Dimitrova DI, Eley T, Guo T, Grasela DM, Pasquinelli C. Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med. 2012 Jan 19;366(3):216-24. doi: 10.1056/NEJMoa1104430.

    PubMed 22256805

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMS-790052, BMS-650032 and Pegylated-interferon alfa-2a in people with Chronic Hepatitis C, run by Bristol-Myers Squibb at 18 sites in 3 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 9 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 18 sites in United States, France, Puerto Rico. 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?

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?

Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in subjects' blood before, during and after treatment (time frame: 12 weeks post treatment). 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 NCT01012895, which also lists 3 linked publications.

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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