Clinical trial NCT01142700: A Study of BMS-824393 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype I
Official title: A Randomized, Placebo-controlled, Phase 2a Study of BMS-824393 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype I
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Chronic Hepatitis C Virus Genotype 1
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-06-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Based on 12-week on-treatment data, at least 1 dose of BMS-824393 can be identified which is safe, well tolerated, and has sufficient antiviral activity to progress to late stage clinical trials when combined with pegIFNα/RBV for treatment of chronically infected hepatitis C virus genotype 1 treatment-naive subjects.


Eligibility criteria: Inclusion Criteria:

* Treatment-naive subjects with genotype 1 chronic HCV
* HCV RNA ≥ 100,000 IU/mL at screening
* Seronegative for HIV and HBsAg
* Liver biopsy within prior 2 years demonstrating no cirrhosis

Exclusion Criteria:

* Any evidence of liver disease other than hepatitis C
* Diagnosed or suspected hepatocellular carcinoma
* Laboratory values: neutrophil count \< 1500 cells/μL, platelet count \< 90,000/μL; Hemoglobin ≤ 12 g/dL (120g/L) for women and ≤ 13 g/dL (130 g/L) for men
* Cirrhosis

Primary outcomes:
measure: Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
timeFrame: Week 4
measure: Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
timeFrame: Week 12
measure: Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
timeFrame: Week 24
measure: Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
timeFrame: Week 48
measure: Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as undetectable HCV RNA
timeFrame: Week 4
measure: Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as undetectable HCV RNA
timeFrame: Week 12
Secondary outcomes:
measure: Proportion of subjects with rapid virologic response (RVR), defined as undetectable RNA
timeFrame: Week 4
measure: Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA
timeFrame: Week 12
measure: Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA undetectable
timeFrame: Week 12 (SVR12)
measure: Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA undetectable
timeFrame: Week 24 (SVR24)
measure: Resistant variants associated with virologic failure
timeFrame: Week 4
measure: Resistant variants associated with virologic failure
timeFrame: Week 12
measure: Resistant variants associated with virologic failure
timeFrame: Follow up Week 12
measure: Resistant variants associated with virologic failure
timeFrame: Week 24
Other outcomes:
Locations:
city: Coronado
country: United States
facility: Local Institution
state: California
city: San Diego
country: United States
facility: Research And Education, Inc.
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Bradenton
country: United States
facility: Bach And Godofsky Infectious Diseases
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Tamarac
country: United States
facility: Vita Medical Center & Research Solutions, Inc.
state: Florida
city: Mareitta
country: United States
facility: Gastrointestinal Specialists Of Georgia Pc
state: Georgia
city: Laurel
country: United States
facility: Maryland Digestive Disease Research
state: Maryland
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Newport News
country: United States
facility: Liver Institute Of Virginia Bon Secours Health System
state: Virginia
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: