Ph IIA Study (SOC +/- NS5B) (HEPCAT)
This study is ongoing, but not recruiting participants.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01193361
First received: August 25, 2010
Last updated: June 18, 2012
Last verified: February 2012
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Purpose
At least 1 dose of BMS-791325 can be identified which is safe, well tolerated, and efficacious when combined with peg-interferon alfa-2a (pegIFNα-2a)/ribavirin (RBV) for the treatment of treatment-naïve, chronically-infected hepatitis C virus (HCV) genotype 1 subjects
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C Virus |
Drug: BMS-791325 Drug: Placebo Drug: Peg-interferon alfa-2a Drug: Ribavirin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 2A Study of BMS-791325 in Combination With Peg Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve Subjects With Chronic Hepatitis C Virus Genotype 1 Infection |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) [ Time Frame: Formal analysis at week 4 (and upon occurrence) ] [ Designated as safety issue: Yes ]
- Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) [ Time Frame: Formal analysis at week 12 (and upon occurrence) ] [ Designated as safety issue: Yes ]
- Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) [ Time Frame: Formal analysis at week 24 post treatment (and upon occurrence) ] [ Designated as safety issue: Yes ]
- Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) [ Time Frame: Formal analysis at week 48 post treatment (and upon occurrence) ] [ Designated as safety issue: Yes ]
- Antiviral activity, as determined by the proportion subjects with eRVR [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
- Antiviral activity, as determined by the proportion subjects with eRVR [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Proportion of subjects with rapid virologic response (RVR), defined as undetectable HCV RNA [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
- Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
- Resistant HCV variants associated with virologic failure [ Time Frame: End of treatment (Week 48) or upon early discontinuation ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 36 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | January 2013 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin |
Drug: BMS-791325
Tablets, Oral, 75 mg, twice daily, 4-48 weeks depending on response
Drug: Peg-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response
Other Name: Pegasys
Drug: Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response
Other Name: Copegus
|
| Experimental: Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin |
Drug: BMS-791325
Tablets, Oral, 150 mg, twice daily, 4-48 weeks depending on response
Drug: Peg-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response
Other Name: Pegasys
Drug: Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response
Other Name: Copegus
|
| Placebo Comparator: Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin |
Drug: Placebo
Tablets, Oral, 0 mg, twice daily, 4-48 weeks depending on response
Drug: Peg-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response
Other Name: Pegasys
Drug: Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response
Other Name: Copegus
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects chronically infected with HCV genotype 1 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 Screening
- HCV RNA ≥ 10*5* IU/mL at Screening
- Less than 4 weeks total prior therapy with an IFN formulation (ie, IFNα, pegIFNα-2a), or RBV and no exposure to IFN or RBV within 24 weeks of Randomization
- Results of a biopsy obtained ≤ 24 months prior to Randomization showing no evidence of cirrhosis
- Body Mass Index (BMI) of 18 to 35 kg/m², inclusive. BMI = weight (kg)/ [height (m)]² at Screening
Exclusion Criteria:
- Liver transplant recipients
- Documented or suspected HCC by imaging or liver biopsy
- 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 chronic hepatitis B virus (HBV) as documented by HBV serologies (eg. HBsAg-seropositive). Patients with resolved HBV infection may participate (eg. HBsAb-seropositive)
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193361
Locations
| United States, California | |
| Advanced Clinical Research Institute | |
| Anaheim, California, United States, 92801 | |
| United States, Illinois | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| United States, Maryland | |
| Mercy Medical Center | |
| Baltimore, Maryland, United States, 21202 | |
| Digestive Disease Associates, P.A. | |
| Baltimore, Maryland, United States, 21229 | |
| United States, Massachusetts | |
| Claudia T. Martorell, Md, Llc | |
| Springfield, Massachusetts, United States, 01107 | |
| United States, North Carolina | |
| Charlotte Gastroenterology & Hepatology, Pllc | |
| Charlotte, North Carolina, United States, 28207 | |
| United States, Oklahoma | |
| Options Health Research, Llc | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Texas | |
| The North Texas Research Institute | |
| Arlington, Texas, United States, 76012 | |
| Alamo Medical Research | |
| San Antonio, Texas, United States, 78215 | |
| United States, Virginia | |
| Metropolitan Research | |
| Fairfax, Virginia, United States, 22031 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01193361 History of Changes |
| Other Study ID Numbers: | AI443-012 |
| Study First Received: | August 25, 2010 |
| Last Updated: | June 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Interferon-alpha Interferon Alfa-2a Interferons Ribavirin |
Peginterferon alfa-2a Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013