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Clinical Trials List

Protocol NumberAI444-026
NCT Number(ClinicalTrials.gov Identfier)NCT01428063

2012-10-01 - 2015-04-30

Phase II

Terminated8

ICD-10B17.10

Acute hepatitis C without hepatic coma

ICD-10B19.20

Unspecified viral hepatitis C without hepatic coma

ICD-9070.51

Hepatitis C without mention of hepatic coma, acute or unspecified

An Open-Label Re-treatment Study with Peg-Interferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C

  • Trial Applicant

    BRISTOL-MYERS SQUIBB (TAIWAN) LTD.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Jia-Horng Kao Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator I-Shyan Sheen Digestive System Department
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chi-Jen Chu Division of General Internal Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 林俊哲 Digestive System Department
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Wan-Long Chuang Digestive System Department
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 胡琮輝 Digestive System Department
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Cheng-Yuan Peng Digestive System Department
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Ting-Tsung Chang Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Hepatitis C virus

Objectives

To assess the efficacy based on the proportion of subjects with SVR12, defined as HCV RNA<LOQ at follow-up Week 12, for all subjects infected with HCV genotype 1 who are prior non-responders to pegIFNα-2a/RBV.

Test Drug

BMS-650032 Asunaprevir / BMS-790052 Daclatasvir

Active Ingredient

BMS-650032 Asunaprevir
BMS-790052 Daclatasvir

Dosage Form

Capsule
Tablet

Dosage

100mg
200mg
30mg
60mg

Endpoints

Proportion of subjects with SVR12, defined as HCV RNA

Inclution Criteria

Males and Females, ≥ 18 years of age;
• HCV Genotype 1, 2, 3, or 4;
• Detectable HCV RNA at screening.

Exclusion Criteria

Exclusion Criteria:
Seropositive for HIV or HBsAg;
• Discontinuation from prior study due to a pegIFNα/RBV-related adverse event;
• Any evidence of liver disease other than HCV-related;
• Diagnosed or suspected hepatocellular carcinoma;
• Laboratory values: neutrophil count < 750 cells/µL (< 500 cells/µL for genotype 1b treatment naive
subjects); platelet count < 50,000 cells/µL, Hemoglobin < 10 g/dL (< 8.5 g/dL for genotype 1b
treatment naive subjects);
• Subjects that received any anti-HCV therapy following initial treatment with BMS-650032,
BMS-790052, or BMS-791325 clinical trial participation;
• Total bilirubin ≥ 34 µmol/mL (or ≥ 2mg/dL) unless a subject has a documented history of Gilbert’s
disease.

The Estimated Number of Participants

  • Taiwan

    10 participants

  • Global

    300 participants

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