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Protocol NumberAI443-123

2014-07-01 - 2015-12-31

Phase III

Terminated7

Study ended1

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

A Phase 3 Study of a daclatasvir/asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects with Chronic Hepatitis C Genotype 1 (UNITY 4)

  • Trial Applicant

    BRISTOL-MYERS SQUIBB (TAIWAN) LTD.

  • Sponsor

    Bristol-Myers Squibb Research and Development

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Ting-Tsung Chang Digestive System Department
National Taiwan University 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 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 Chi-Jen Chu Division of General Internal Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

  • 黃惠君 Division of General Internal Medicine

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Ming-Lung Yu Digestive System Department
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Sheng-Shun Yang Digestive System Department
Taichung Veterans General 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 Cheng-Yuan Peng Digestive System Department
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

13 Study ended

Condition/Disease

Chronic Hepatitis C Genotype 1

Objectives

Primary Objective To demonstrate that the proportion of treatment-naive subjects treated with DCV 3DAA FDC who achieve SVR12, defined as HCV RNA < LOQ target detected or target not detected (LOQ TD/TND) at follow-up Week 12, is significantly higher than the 75% historical threshold rate for the current SOC. Secondary Objectives Key Secondary Objectives  To evaluate the proportion of IFNα experienced subjects who achieve SVR12;  To evaluate the proportion of subjects in each cohort (treatment-naive subjects and IFNα experienced subjects) who achieve HCV RNA < LOQ TD/TND at each of the following Weeks: 1, 2, 4, 6, 8, and 12; EOT; post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24);  To evaluate the proportion of subjects in each cohort who achieve HCV RNA < LOQ TND at each of the following Weeks: 1, 2, 4, 6, 8, and 12; EOT; post-treatment Weeks 4, 8, 12 and 24;  To evaluate on-treatment safety in each cohort, as measured by the frequency of Serious Adverse Events (SAEs), discontinuations due to AEs, and selected Grade 3 - 4 laboratory abnormalities (including hematologic and liver function, based on the US National Institutes of Health Division of AIDs [DAIDS] criteria).

Test Drug

Daclatasvir/Asunaprevir/BMS-791325; Film coated tablet; 30 mg/200 mg/75 mg (as the free base)

Active Ingredient

Daclatasvir/Asunaprevir/BMS-791325

Dosage Form

Film coated tablet

Dosage

30 mg/200 mg/75 mg (as the free base)

Endpoints

Primary Endpoint(s)
Proportion of treated subjects with SVR12 in the naive cohort, defined as HCV RNA < LOQ target detected or
target not detected (LOQ TD/TND) at post-treatment follow-up Week 12.
Secondary Endpoint(s)
 Proportion of treated subjects with SVR12 in the IFNα experienced cohort, defined as HCV RNA < LOQ target
detected or target not detected (LOQ TD/TND) at post-treatment follow-up Week 12;
 Proportion of subjects in each cohort who achieve HCV RNA < LOQ TD/TND at each of the following
Weeks 1, 2, 4, 6, 8, and 12; EOT; post-treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24);
 Proportion of subjects in each cohort who achieve HCV RNA < LOQ TND at each of the following Weeks 1, 2,
4, 6, 8, and 12; EOT; post-treatment Weeks 4, 8, 12 and 24;
 On-treatment safety in each cohort, as measured by frequency of SAEs, discontinuations due to AEs, and
selected Grade 3 - 4 laboratory abnormalities (including hematologic and liver function, based on DAIDS
criteria);
 Proportion of subjects with anemia defined as Hb < 10 g/dL on-treatment who had Hb   g/dL at baseline in
each cohort;
 Proportion of subjects in each cohort achieving SVR12 associated with HCV genotype subtype 1a vs 1b;
 Proportion of subjects in each cohort achieving SVR12 associated with IL28B rs12979860 SNP status
(CC genotype or non CC genotype);
 To evaluate the proportion of cirrhotic and noncirrhotic subjects who achieve SVR12;
 To evaluate on-treatment safety of non-cirrhotic vs. cirrhotic subjects cirrhosis, as measured by the frequency of
SAEs, discontinuations due to AEs, and selected Grade 3 - 4 laboratory abnormalities (including hematologic
and liver function, based on DAIDS criteria).

Inclution Criteria

 Subject chronically infected with HCV GT-1 as documented by positive HCV RNA, anti-HCV antibody and
HCV GT-1 at screening and either;
a) Positive anti-HCV antibody, HCV RNA or a positive HCV genotype test at least 6 months prior to
screening; or
b) Liver biopsy consistent with chronic HCV infection at screening (or a liver biopsy performed within
36 months prior to screening with evidence of chronic Hepatitis C disease, such as the presence of fibrosis);
OR;
c) Diagnosed chronic hepatitis by imaging studies at screening (ie, CT and MRI).
Subject is eligible if with any subtype of HCV genotype 1: GT-1mixed subtype, indeterminate subtypes or other
variants of genotype 1 are permissible and will be considered as genotype 1a;
 Subject without cirrhosis as documented by:
a) Liver biopsy  3 years from screening demonstrating a Metavir Fibrosis Score of F0-3 (or equivalent); OR
b) Fibroscan  1 year from screening  14.6 kPa (equivalent to Metavir F0-3); if a Fibroscan was not
performed within one year of screening, a Fibroscan is required at screening if this is the method used to
demonstrate lack of cirrhosis; OR
c) A Fibrotest score of  0.48 and APRI  1.
 Subjects with compensated cirrhosis (Child Pugh Class A) as documented by:
a) Liver biopsy at any time demonstrating a Metavir Fibrosis Score of F4 (or equivalent); OR
b) Fibroscan  1 year from screening > 14.6 kPa; if a Fibroscan was not performed within one year of
screening, a Fibroscan is required before randomization; OR
c) FibroTest score of ≥ 0.75 and APRI of > 2 during screening
 Subject has a HCV RNA  10,000 IU/mL at screening;
Treatment-naïve subject with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), RBV, or HCV
DAA (protease, polymerase inhibitor, etc.)
IFN experienced subject is eligible if the following conditions are met:
a) Received previous treatment with IFNα, with or without RBV. Documentation of prior virologic response
to treatment is desirable but not strictly required. Subject who did not complete treatment due to laboratory
abnormality or intolerable side effect is eligible.
b) IFN and/or RBV therapy must have been completed 12 weeks prior to initiating therapy in this study
c) Previous exposure to any other anti-HCV agents (eg DAA) other than IFN or RBV are not permitted.

Exclusion Criteria

 Liver or any other transplant (including hematopoietic stem cell transplants) other than cornea and hair;
 Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or
squamous cell carcinoma of the skin) within 5 years prior to screening;
 Documented or suspected HCC, as evidenced by previously obtained imaging studies or liver biopsy (or on a
screening imaging study/liver biopsy if this was performed);
 Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence
of ascites, bleeding varices, or hepatic encephalopathy.

The Estimated Number of Participants

  • Taiwan

    80 participants

  • Global

    160 participants

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