Study in Genotype 2/3 Subjects With Chronic Hepatitis C

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01257204
First received: December 1, 2010
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

To identify a shorter duration of antiviral therapy (12 or 16 weeks) of the combination of BMS-790052 with Pegylated-interferon alfa 2a and Ribavirin.


Condition Intervention Phase
Hepatitis C Virus
Drug: Placebo
Drug: BMS-790052
Drug: Pegylated-interferon alfa 2a
Drug: Ribavirin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2B Pilot Study of Short-Term Treatment of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 2 or 3 Infection

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To assess antiviral activity, as determined by the proportion of subjects who achieve SVR24 for each HCV genotype, defined as undetectable HCV RNA [ Time Frame: Follow-up Week 24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) [ Time Frame: After all subjects completed Week 16 ] [ Designated as safety issue: Yes ]
  • To assess safety, as measured by the frequency of SAEs and discontinuations due to AEs [ Time Frame: Follow-up Week 12 ] [ Designated as safety issue: Yes ]
  • To assess safety, as measured by the frequency of SAEs and discontinuations due to AEs [ Time Frame: Follow-up Week 24 or 36 ] [ Designated as safety issue: Yes ]
  • To assess the proportion of subjects with RVR for each HCV genotype, ie, undetectable HCV RNA [ Time Frame: After all subjects completed Week 16 ] [ Designated as safety issue: Yes ]
  • To assess the proportion of subjects with RVR for each HCV genotype, ie, undetectable HCV RNA [ Time Frame: Follow-up Week 12 ] [ Designated as safety issue: Yes ]
  • To assess the proportion of subjects with RVR for each HCV genotype, ie, undetectable HCV RNA [ Time Frame: Follow-up Week 24 or 36 ] [ Designated as safety issue: Yes ]
  • To assess the proportion of subjects with SVR12 for each HCV genotype ie, undetectable HCV RNA [ Time Frame: After all subjects completed Week 16 ] [ Designated as safety issue: Yes ]
  • To assess the proportion of subjects with SVR12 for each HCV genotype ie, undetectable HCV RNA [ Time Frame: Follow-up Week 12 ] [ Designated as safety issue: Yes ]
  • To assess the proportion of subjects with SVR12 for each HCV genotype ie, undetectable HCV RNA [ Time Frame: Follow-up Week 24 or 36 ] [ Designated as safety issue: Yes ]
  • Frequency of genotypic substitutions associated with virologic failure for each HCV genotype [ Time Frame: After all subjects completed Follow-up Week 48 ] [ Designated as safety issue: No ]

Enrollment: 152
Study Start Date: December 2010
Study Completion Date: September 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Placebo + Pegylated-interferon alfa 2a + Ribavirin
Drug: Placebo
Tablets, Oral, 0 mg, once daily, 24 weeks
Drug: Pegylated-interferon alfa 2a
Solution for injection, subcutaneous injection, 180 µg/0.5 mL, once weekly, 24 weeks
Other Name: Pegasys®
Drug: Ribavirin
Tablets, Oral, 800 mg, twice daily, 24 weeks
Other Name: Copegus®
Experimental: 12 Week Cohort

BMS-790052 + Pegylated-interferon alfa 2a + Ribavirin

Followed by Control Arm if no response: (Placebo + Pegylated-interferon alfa 2a + Ribavirin)

Drug: BMS-790052
Tablets, Oral, 60 mg, once daily, 12 weeks
Drug: Pegylated-interferon alfa 2a
Solution for injection, subcutaneous injection, 180 µg/0.5 mL, once weekly, 12 weeks
Other Name: Pegasys®
Drug: Ribavirin
Tablets, Oral, 800 mg, twice daily, 12 weeks
Other Name: Copegus®
Experimental: 16 Week Cohort

BMS-790052 + Pegylated-interferon alfa 2a + Ribavirin

Followed by Control Arm if no response: (Placebo + Pegylated-interferon alfa 2a + Ribavirin)

Drug: BMS-790052
Tablets, Oral, 60 mg, once daily, 16 weeks
Drug: Pegylated-interferon alfa 2a
Solution for injection, subcutaneous injection, 180 µg/0.5 mL, once weekly, 16 weeks
Other Name: Pegasys®
Drug: Ribavirin
Tablets, Oral, 800 mg, twice daily, 16 weeks
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 either HCV Genotype 2 or 3
  • No previous exposure to an interferon formulation (ie IFNα, pegIFNα) or RBV;
  • Body Mass Index (BMI) of 18 to 35 kg/m², inclusive. BMI = weight (kg)/[height (m)]²
  • Males and female, 18 - 70 years of age

Exclusion Criteria:

  • Liver transplant recipients
  • Documented or suspected HCC
  • Evidence of decompensated cirrhosis
  • History of chronic hepatitis B virus (HBV). Patients with resolved HBV infection may participate
  • Current or known history of cancer
  • Any gastrointestinal disease or surgical procedure that may impact the absorption of study drug
  • Inability to tolerate oral medication
  • Poor venous access
  • Severe psychiatric disease
  • History of chronic pulmonary disease
  • History of cardiomyopathy, coronary artery disease (including angina), interventive procedure for coronary artery disease (including angioplasty, stent procedure, or cardiac bypass surgery), ventricular arrhythmia, or other clinically significant cardiac disease
  • Historical or current ECG findings indicative of cardiovascular instability
  • Pre-existing ophthalmologic disorders considered clinically significant on eye
  • History of uncontrolled diabetes mellitus
  • Any known contraindication to pegIFNα-2a or RBV, not otherwise specified.
  • Positive HBsAg, HIV-1 or HIV-2 Ab
  • Prior exposure to any HCV direct antiviral agent (eg, HCV protease, polymerase, previous NS5A inhibitors, etc)
  • Exposure to any investigational drug or placebo
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01257204

  Show 26 Study Locations
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: NCT01257204     History of Changes
Other Study ID Numbers: AI444-031, 2010-022408-28
Study First Received: December 1, 2010
Last Updated: June 24, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Biological and Radiopharmaceutical Drugs
Denmark: Lægemiddelstyrelsen
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Istituto Superiore di Sanità (ISS)
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Interferons
Peginterferon alfa-2a
Ribavirin
Anti-Infective Agents
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014