Study in Genotype 2/3 Subjects With Chronic Hepatitis C - Full Text View

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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Interferon Ribavirin Interferon Alfa-2a Peginterferon Alfa-2a

U.S. FDA Resources

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 ]

Estimated Enrollment:	144
Study Start Date:	December 2010
Estimated Study Completion Date:	September 2012
Estimated 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

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

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

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:	April 30, 2012
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, Chronic
Hepatitis C
Hepatitis C, Chronic
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

ClinicalTrials.gov processed this record on May 22, 2013