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Chronic Hepatitis CPhase 2NCT01455090

Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications

A Phase 2 study testing BMS-650032, BMS-790052 and BMS-791325 in people with Chronic Hepatitis C, run by Bristol-Myers Squibb at 32 sites in 3 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 estimate the rate of sustained virologic response (SVR) SVR12, where SVR12 is defined as HCV RNA < LOQ (detectable or undetectable) 12 weeks post-treatment in Genotype 1 \& Genotype 4 treatment naive patients, and Genotype (GT1) infected patients who are prior null responders to… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Hepatitis C
What is being tested?
BMS-650032, BMS-790052 and BMS-791325
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
32 sitesin 3 countries
Study dates
30 Nov 2011to 31 Jul 2015
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women, ages ≥18 years of age
  • Subjects who are naive to HCV treatment, defined as no previous exposure to an Interferon (IFN), Ribavirin (RBV); or any HCV-specific direct acting antiviral or experimental therapy or subjects who are null responders to previous pegylated Interferon alfa (pegIFNα) plus Ribavirin (RBV) treatment
  • Subjects should have chronic hepatitis C (CHC) as documented by:
  • Positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to screening, and positive for HCV RNA and Anti-HCV antibody at the time of screening, or
  • Positive for anti-HCV antibody and HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed prior to enrollment with evidence of CHC disease, such as the presence of fibrosis)
  • HCV genotype 1a, 1b or 4 only
Show all 13Show fewer
  • HCV RNA viral load of ≥10,000 IU/mL at screening
  • Have one of the following:
  • Documented Fibrotest score of ≤0.72 and aspartate transferase (transminase) to platelet ratio index (APRI) ≤2; OR
  • Documented liver biopsy within 36 months preceding Day 1 showing absence of cirrhosis OR
  • Documented Fibroscan® ultrasound (where approved) within 12 months of screening showing absence of cirrhosis
  • Body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive
  • Subjects with compensated Child-Pugh A cirrhosis as documented by history of cirrhosis with any prior liver biopsy or Fibroscan® ultrasound (where approved) within 12 months prior to screening

Who cannot join

  • Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis,metabolic liver disease, alcoholic liver disease, toxin exposures)
  • History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis
  • Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
  • Documented or suspected hepatocellular carcinoma (HCC)
  • Positive for hepatitis B surface antigen (HBsAg)
  • Positive for Human Immunodeficiency Virus-1 (HIV-1) and/or Human Immunodeficiency Virus-2 (HIV-2) antibodies
  • Alanine transferase (transminase) (ALT) >5x upper limit of normal (ULN)
  • Total Bilirubin ≥2 mg/dL

Trial locations and contacts

32 sites in 3 countries.

32 sites in 3 countries

United States26 sites

  • Texas Clinical Research Institute

    Arlington, Texas, 76012

  • Atlanta Gastroenterology Associates, Llc

    Atlanta, Georgia, 30308

  • University Of Colorado Denver And Hospital

    Aurora, Colorado, 80045

  • Mercy Medical Center, Inc.

    Baltimore, Maryland, 21202

  • The Kirklin Clinic

    Birmingham, Alabama, 35294

  • Southern California Research Center

    Coronado, California, 92118

  • Metropolitan Research

    Fairfax, Virginia, 22031

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Id Care

    Hillsborough, New Jersey, 08844

  • Research Specialists Of Texas

    Houston, Texas, 77030

  • Peter J Ruane Md Inc

    Los Angeles, California, 90036

  • Va Greater Los Angeles Healthcare System

    Los Angeles, California, 90073

  • Johns Hopkins University

    Lutherville, Maryland, 21093

  • Dean Clinic

    Madison, Wisconsin, 53715

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Lifetree Clinical Research

    Salt Lake City, Utah, 84106

  • Alamo Medical Research

    San Antonio, Texas, 78215

  • Research And Education, Inc.

    San Diego, California, 92105

  • Precision Research Institute, Llc

    San Diego, California, 92114

  • Medical Associates Research Group

    San Diego, California, 92123

  • Southwest Care Center

    Santa Fe, New Mexico, 87505

  • Miami Research Associates

    South Miami, Florida, 33143

  • James J Peters Vamc

    The Bronx, New York, 10468

  • Options Health Research, Llc

    Tulsa, Oklahoma, 74104

  • Healthcare Research Consultants

    Tulsa, Oklahoma, 74135

  • Medstar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

Other trials in United States

France5 sites

  • Local Institution

    Clichy, 92118

  • Local Institution

    Créteil, 9410

  • Local Institution

    Limoges, 87042

  • Local Institution

    Marseille, 13285

  • Local Institution

    Paris, 75679

Other trials in France

Puerto Rico1 site

  • Fundacion De Investigacion De Diego

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: Open-Label, Multiple-Dose, Dose Escalation Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Coadministration of BMS-650032, BMS-790052, and BMS-791325 When Administered for 24 or 12 Weeks in Treatment-Naïve Subjects Infected With Hepatitis C Virus Genotype 1

The purpose of this study is to estimate the rate of sustained virologic response (SVR) SVR12, where SVR12 is defined as HCV RNA < LOQ (detectable or undetectable) 12 weeks post-treatment in Genotype 1 \& Genotype 4 treatment naive patients, and Genotype (GT1) infected patients who are prior null responders to pegIFN/ribavirin

Read the detailed description

IND numbers: 79,599; 101,943

Being tested
BMS-650032, BMS-790052, BMS-791325, 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-650032Drug

    Also called Asunaprevir (ASV)

  • BMS-790052Drug

    Also called Daclatasvir (DCV)

  • BMS-791325Drug

  • RibavirinDrug

    Also called Copegus®

Study groups in NCT01455090
Study groupRoleWhat they receive
Group 1:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(75mg)ExperimentalBMS-650032 200 mg tablet by mouth twice daily for 24 Weeks BMS-790052 60 mg tablet by mouth once daily for 24 Weeks BMS 791325 75 mg table by mouth twice daily for 24 Weeks
Receives: Drug: BMS-650032; Drug: BMS-790052; Drug: BMS-791325
Group 2:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(75mg)ExperimentalBMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 60 mg tablet by mouth once daily for 12 Weeks BMS 791325 75 mg table by mouth twice daily for 12 Weeks
Receives: Drug: BMS-650032; Drug: BMS-790052; Drug: BMS-791325
Group 3:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(150mg)Experimental* Contingent upon review of safety data from all available treated subjects from Groups 1 and 2 BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks BMS-790052 60 mg tablet by mouth once daily for 24 Weeks BMS 791325 150 mg table by mouth twice daily for 24 Weeks
Receives: Drug: BMS-650032; Drug: BMS-790052; Drug: BMS-791325
Group 4:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(150mg)Experimental* Contingent upon review of safety data from all available treated subjects from Groups 1 and 2 BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 60 mg tablet by mouth once daily for 12 Weeks BMS 791325 150 mg table by mouth twice daily for 12 Weeks
Receives: Drug: BMS-650032; Drug: BMS-790052; Drug: BMS-791325
Group 5:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)Experimental* Genotype 1 treatment-naive subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 75 mg table by mouth twice daily for 12 Weeks
Receives: Drug: BMS-650032; Drug: BMS-790052; Drug: BMS-791325
Group 6:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)Experimental* Genotype 1 treatment-naive subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 150 mg table by mouth twice daily for 12 Weeks
Receives: Drug: BMS-650032; Drug: BMS-790052; Drug: BMS-791325
Group 7:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)Experimental* Genotype 4 treatment-naive subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 75 mg table by mouth twice daily for 12 Weeks
Receives: Drug: BMS-650032; Drug: BMS-790052; Drug: BMS-791325
Group 8:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)Experimental* Genotype 4 treatment-naive subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 150 mg table by mouth twice daily for 12 Weeks
Receives: Drug: BMS-650032; Drug: BMS-790052; Drug: BMS-791325
Group 9:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)Experimental* Genotype 1 treatment-null/non-responder subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 75 mg table by mouth twice daily for 12 Weeks
Receives: Drug: BMS-650032; Drug: BMS-790052; Drug: BMS-791325
Group10:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)Experimental* Genotype 1 treatment-null/non-responder subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 150 mg table by mouth twice daily for 12 Weeks
Receives: Drug: BMS-650032; Drug: BMS-790052; Drug: BMS-791325
Group11:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)Experimental* Genotype 1 treatment-null/non-responder subjects BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks BMS-790052 30 mg tablet by mouth twice daily for 24 Weeks BMS 791325 75 mg table by mouth twice daily for 24 Weeks
Receives: Drug: BMS-650032; Drug: BMS-790052; Drug: BMS-791325
Group12:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)Experimental* Genotype 1 treatment-null/non-responder subjects BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks BMS-790052 30 mg tablet by mouth twice daily for 24 Weeks BMS 791325 150 mg table by mouth twice daily for 24 Weeks
Receives: Drug: BMS-650032; Drug: BMS-790052; Drug: BMS-791325
Grp13:BMS-650032(200mg)+BMS-790052(30mg)+BMS-791325(75mg)+RBVExperimental* Genotype 1 treatment-naive subjects BMS-650032 200 mg tablets orally twice daily 12 weeks BMS-790052 30 mg tablets orally twice daily 12 weeks BMS-791325 75 mg tablets orally twice daily 12 weeks Ribavirin (RBV) tablets orally weight based dosing daily 12 weeks [if subject is < 75 kg: 1000 mg per day orally (2 x 200 mg tablets in AM and 3 x 200 mg tablets in PM), or if ≥ 75 kg: 1200 mg per day orally (3 x 200 mg tablets in AM and 3 x 200 mg tablets in PM]
Receives: Drug: BMS-650032; Drug: BMS-790052; Drug: BMS-791325; Drug: Ribavirin

What is being measured

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

  1. Sustained virologic response (SVR) at 12 weeks post-treatment (SVR12)

    Measured: 12 weeks post-treatment

Secondary outcomes (12)

  1. Proportion of subjects with HCV ribonucleic acid (RNA) < limit of quantification (LOQ) (detectable and undetectable)

    Measured: Weeks 1, 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22 and 24 weeks of therapy; at end of treatment (EOT) (following 12 or 24 weeks of treatment, by Group); and Weeks 4, 12, 24, 36, and 48 weeks post-treatment

  2. Proportion of subjects with HCV ribonucleic acid (RNA) undetectable

    Measured: Weeks 1, 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22 and 24 weeks of therapy; at end of treatment (EOT) (following 12 or 24 weeks of treatment, by Group); and Weeks 4, 12, 24, 36, and 48 weeks post-treatment

  3. Proportion of subjects who experience viral breakthrough

    viral breakthrough defined as:

    • Any increase in HCV RNA ≥ 1 log10 from nadir or
    • Any quantifiable HCV RNA ≥ 25 IU/mL (> LOQ) on or after Week 8

    Measured: Formal analysis at SVR12, Week 48 of follow up period (or upon occurrence)

  4. Proportion of subjects who experience viral relapse defined as confirmed quantifiable HCV RNA ≥ 25 IU/mL (>LOQ) in a subject with HCV RNA < LOQ or undetectable at End of treatment (EOT)

    Measured: End of treatment (Maximum up to 24 Weeks)

  5. Maximum observed plasma concentration (Cmax) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712

    Measured: Day 1 and Day 14

  6. Observed plasma concentration at 12 hours (C12) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712

    Measured: Day 1 and Day 14

  7. Observed plasma concentration at 24 hours (C24) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712

    Measured: Day 1 and Day 14

  8. Trough observed plasma concentration (Ctrough) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712

    Measured: Day 1 and Day 14

  9. Time of maximum observed plasma concentration (Tmax) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712

    Measured: Day 1 and Day 14

  10. Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-650032, BMS-790052, BMS 791325, and BMS-794712

    Measured: Day 1 and Day 14

  11. HCV genomic substitutions associated with exposure of BMS-650032, BMS-790052, and BMS-791325

    Measured: At the time of viral breakthrough or relapse

  12. Frequency of deaths, serious adverse events (SAEs), discontinuations due to adverse events (AEs), severity Grade 3/4 AEs, and severity Grade 3/4 laboratory abnormalities

    Measured: Formal analysis at week 48 of follow up period (or upon occurrence)

Timeline

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

  1. First posted19 Oct 2011 (estimated)
  2. Study start30 Nov 2011
  3. Primary completion31 Mar 2014
  4. Study completion31 Jul 2015

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
320 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01455090
Sponsor's protocol ID
AI443-014
Other IDs
2011-002788-11
Status last verified
Apr 2017
First submitted
18 Oct 2011
Last updated
27 Apr 2017
Results posted
No
Data monitoring committee
No

Publications

  • Everson GT, Sims KD, Thuluvath PJ, Lawitz E, Hassanein T, Rodriguez-Torres M, Desta T, Hawkins T, Levin JM, Hinestrosa F, Rustgi V, Schwartz H, Younossi Z, Webster L, Gitlin N, Eley T, Huang SP, McPhee F, Grasela DM, Gardiner DF. Daclatasvir + asunaprevir + beclabuvir +/- ribavirin for chronic HCV genotype 1-infected treatment-naive patients. Liver Int. 2016 Feb;36(2):189-97. doi: 10.1111/liv.12964. Epub 2015 Dec 6.

    PubMed 26473667

  • Everson GT, Sims KD, Rodriguez-Torres M, Hezode C, Lawitz E, Bourliere M, Loustaud-Ratti V, Rustgi V, Schwartz H, Tatum H, Marcellin P, Pol S, Thuluvath PJ, Eley T, Wang X, Huang SP, McPhee F, Wind-Rotolo M, Chung E, Pasquinelli C, Grasela DM, Gardiner DF. Efficacy of an interferon- and ribavirin-free regimen of daclatasvir, asunaprevir, and BMS-791325 in treatment-naive patients with HCV genotype 1 infection. Gastroenterology. 2014 Feb;146(2):420-9. doi: 10.1053/j.gastro.2013.10.057. Epub 2013 Oct 30.

    PubMed 24184132

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMS-650032, BMS-790052 and BMS-791325 in people with Chronic Hepatitis C, run by Bristol-Myers Squibb at 32 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 13 inclusion and 8 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 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 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?

Sustained virologic response (SVR) at 12 weeks post-treatment (SVR12) (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 NCT01455090, which also lists 2 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 27 Apr 2017.

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