Clinical Trials List
2013-02-01 - 2016-12-31
Phase III
Terminated10
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 Randomized, Double Blind, Regional Multi-National Evaluation of Daclatasvir in Combination with Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naïve Subjects with Chronic Hepatitis C Genotypes 1 and 4
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Trial Applicant
BRISTOL-MYERS SQUIBB (TAIWAN) LTD.
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Sponsor
Bristol-Myers Squibb
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 陳介章 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 李癸汌 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chun-Yen Lin Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 葉宏仁 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 李佩倫 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 趙景華 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 黎國洪 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Ming-Lung Yu Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Hsueh-Chou Lai Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chun-Jen Liu Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
PegIFNαnRibavirin
Dosage Form
tab
Dosage
200
60
Endpoints
Inclution Criteria
1) Signed Written Informed Consent
a) Freely given informed consent must be obtained from subjects prior to clinical trial participation, including informed consent for any screening procedures conducted to establish subject eligibility for the study.
2) Target Population
a) Subjects chronically infected with HCV Genotype 1 or 4 as documented by positive HCV RNA and anti-HCV antibody at screening and either:
i) positive anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to screening; or
ii) liver biopsy or Fibroscan® consistent with chronic HCV infection (evidence of fibrosis and/or inflammation);
b) HCV RNA viral load of ≥ 104 IU/mL (10,000 IU/mL) at screening;
c) Seronegative for HIV and HBsAg;
d) Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population). If a subject does not have a documented history of cirrhosis, a liver biopsy within three years prior to enrollment is required to demonstrate the absence of cirrhosis. If there is a history of cirrhosis, any prior liver biopsy is sufficient. For countries where liver biopsy is not required prior to treatment and where non-invasive imaging tests (Fibroscan® ultrasound) are approved for staging of liver disease, non-invasive
imaging test results may be used to assess the extent of liver disease. A Fibroscan® done prior to screening is acceptable if it was performed within one year of screening (≥ 14.6 kPa should be considered consistent with cirrhosis).24 If the prior Fibroscan® was not performed within one year of screening, a new Fibroscan® is required before study drug dosing. If a subject has both liver biopsy and Fibroscan®, the result of the liver biopsy takes precedence over those of the Fibroscan®.
e) No previous exposure to an interferon formulation (eg, IFNα, pegIFNα), RBV, or HCV direct antiviral agent (protease, polymerase inhibitor, etc);
f) Body Mass Index (BMI) ≥ 18 kg/m2 and ≤ 35 kg/m2 inclusive.
BMI = weight (kg)/ [height (m)]2 at screening;
g) Subject Re-enrollment: This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (ie, subject has not been randomized / has not been treated). If re-enrolled, the subject must be re-consented and all screening procedures (see Table 5.1A) must be re-done.
Exclusion Criteria
1) Target Disease Exceptions
a) Infected with HCV other than Genotype 1 or 4.
2) Medical History and Concurrent Diseases
a) Liver transplant recipients;
b) Evidence of decompensated liver disease including, but not limited to, a history or
presence of ascites, bleeding varices, or hepatic encephalopathy;
c) 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);
d) Evidence of a medical condition contributing to chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures);
e) History of chronic hepatitis B virus (HBV) as documented by HBV serologies (eg, HBsAg-seropositive). Subjects with resolved HBV infection may participate (eg, HBsAb-seropositive with concurrent HBsAg-seronegative);
f) History of HIV infection;
g) 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 enrollment;
h) Known history of coagulopathy including, but not limited to hemophilia;
i) Any gastrointestinal disease or surgical procedure that may impact the absorption of study drug;
j) Active substance abuse as defined by DSM-IV, Diagnostic Criteria for Drug and Alcohol Abuse (Appendix 1), which in the opinion of the investigator would make the candidate inappropriate for participation in this study.
k) Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair;
l) Uncontrolled diabetes (any subject with screening HgA1c ≥ 8.5 must be excluded);
m) Confirmed uncontrolled hypertension (any screening systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg should be excluded unless discussed with the central medical monitor);
n) Inability to tolerate oral medication;
o) Poor venous access;
p) Any other medical, psychiatric and/or social reason which in the opinion of the investigator would make subject inappropriate for study.
The Estimated Number of Participants
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Taiwan
80 participants
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Global
885 participants
