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

NCT01142700 | Withdrawn Phase 2

• 2 other identifiers: AI451-0042010-018702-36
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 11

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.

Conditions

Chronic Hepatitis C Virus Genotype 1

Outcome Measures

Primary Outcomes (6)

• Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)

  Week 4

• Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)

  Week 12

• Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)

  Week 24

• Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)

  Week 48

• Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as undetectable HCV RNA

  Week 4

• Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as undetectable HCV RNA

  Week 12

Secondary Outcomes (8)

• Proportion of subjects with rapid virologic response (RVR), defined as undetectable RNA

  Week 4

• Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA

  Week 12

• Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA undetectable

  Week 12 (SVR12)

• Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA undetectable

  Week 24 (SVR24)

• Resistant variants associated with virologic failure

  Week 4

Study Arms (5)

BMS-824393 (10mg)

EXPERIMENTAL

Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12

Drug: BMS-824393; Drug: Peginterferon Alpha-2a; Drug: Ribavirin

BMS-824393 (30 mg)

EXPERIMENTAL

Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12

Drug: BMS-824393; Drug: Peginterferon Alpha-2a; Drug: Ribavirin

BMS-824393 (100 mg)

EXPERIMENTAL

Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12

Drug: BMS-824393; Drug: Peginterferon Alpha-2a; Drug: Ribavirin

Placebo

PLACEBO COMPARATOR

Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12

Drug: Placebo; Drug: Peginterferon Alpha-2a; Drug: Ribavirin

Peginterferon alfa-2a plus Ribavirin

OTHER

Weeks 13 - 48

Drug: Peginterferon Alpha-2a; Drug: Ribavirin

Interventions

BMS-824393 DRUG

Capsule, Oral, 10 mg, once daily

BMS-824393 (10mg)

Placebo DRUG

Capsule, Oral, 0 mg, once daily

Placebo

Peginterferon Alpha-2a DRUG

Syringe, subcutaneous 180 mcg/0.5 mL, weekly

Also known as: Pegasys

BMS-824393 (100 mg); BMS-824393 (10mg); BMS-824393 (30 mg); Peginterferon alfa-2a plus Ribavirin; Placebo

Ribavirin DRUG

Tablet, Oral, 400 or 600 mg based on weight (am) and 600 mg (pm), twice daily

Also known as: Copegus

BMS-824393 (100 mg); BMS-824393 (10mg); BMS-824393 (30 mg); Peginterferon alfa-2a plus Ribavirin; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (11)

Local Institution

Coronado, California, 92118, United States

Location

Research And Education, Inc.

San Diego, California, 92105, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Bach And Godofsky Infectious Diseases

Bradenton, Florida, 34209, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

Vita Medical Center & Research Solutions, Inc.

Tamarac, Florida, 33319, United States

Location

Gastrointestinal Specialists Of Georgia Pc

Mareitta, Georgia, 30060, United States

Location

Maryland Digestive Disease Research

Laurel, Maryland, 20707, United States

Location

Local Institution

Philadelphia, Pennsylvania, 19141, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Liver Institute Of Virginia Bon Secours Health System

Newport News, Virginia, 23602, United States

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Interventions

peginterferon alfa-2a; Ribavirin

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 3, 2010
• First Posted: June 11, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 15, 2011

Record last verified: 2011-03

Locations

US (11)