Clinical Trials List
2012-08-01 - 2014-06-30
Phase III
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
A phase 3 study with Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin(P/R), Intolerant or Ineligible to P/R Subjects and Treatment –Naïve Subjects with Chronic Hepatitis C Genotype 1b Infection
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Trial Applicant
BRISTOL-MYERS SQUIBB (TAIWAN) LTD.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 楊宏志 Division of General Internal Medicine
- Chun-Jen Liu Division of General Internal Medicine
- 蘇東弘 Division of General Internal Medicine
- Chen-Hua Liu Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Yi-Cheng Chen Digestive System Department
- Chien-Hao Huang Digestive System Department
- 陳威廷 Digestive System Department
- Chun-Yen Lin Digestive System Department
- Wen-Juei Jeng Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 邱彥程 Division of General Internal Medicine
- Pin-Nan Cheng Division of General Internal Medicine
- 吳毅晉 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Jee-Fu Huang Digestive System Department
- 謝明彥 Digestive System Department
- Chung-Feng Huang Digestive System Department
- Ming-Lun Yeh Digestive System Department
- Chia-Yen Dai Digestive System Department
- Ming-Lung Yu Digestive System Department
- 侯乃仁 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Jing-Houng Wang Digestive System Department
- 紀廣明 Digestive System Department
- 郭垣宏 Digestive System Department
- 陳建宏 Digestive System Department
- 曾柏霖 Digestive System Department
- 李全膜 Digestive System Department
- 洪肇宏 Digestive System Department
- 顏毅豪 Digestive System Department
- 戴維震 Digestive System Department
- 趙景華 Digestive System Department
- 張國欽 Digestive System Department
- 蔡明釗 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 高榮達 Digestive System Department
- Hsueh-Chou Lai Digestive System Department
- 陳昇弘 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Daclatasvir (BMS-790052)
Dosage Form
Tablet
Dosage
60mg
Endpoints
100 subjects will receive placebo. Null or partial responders and intolerant or ineligible subjects will be
treated with ASV plus (+) DCV for 24 weeks. Treatment-naive subjects will be randomized 2:1 to receive
ASV + DCV for 24 weeks or PBO for 12 weeks followed by ASV + DCV for 24 weeks in protocol
AI444026 (see Figure 1). Null/partial responder subjects and subjects in the ASV + DCV arm of the
treatment naive cohort meeting pre-specified rescue criteria may, at the discretion of the investigator, have
therapeutic rescue instituted with QUAD (ASV + DCV + pegylated interferon alfa 2a and ribavirin).
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.
Target Population
a) Subjects must be able to understand and agree to comply with the prescribed
dosing regimens and procedures, including the use of the paper or electronic
dosing diary, report for regularly scheduled study visits, and reliably
communicate with study personnel about adverse events and concomitant
medications;
b) Subjects chronically infected with HCV genotype 1b only 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 consistent with chronic HCV infection (evidence of fibrosis and/or inflammation) unless the subject is known to be cirrhotic;
c) Subjects must meet one of the following:
i) Subjects who previously failed treatment with P/R, classified as previous null or partial responders based on previous therapy:
(1) Previous null responders, defined as either:
(a) Subjects who, after at least 12 weeks of therapy with pegIFNα plus
RBV, have never attained ≥ 2 log10 decline in HCV RNA level, or;
(b) Subjects who, after 4 weeks of therapy with pegIFNα/RBV have never attained ≥ 1 log10 decline in HCV RNA level (limited to no more than 10% of the null or partial responder cohort).
Exclusion Criteria
1) Medical History and Concurrent Diseases
a) Liver or any other organ transplant (including hematopoietic stem cell transplants)
other than cornea and hair;
b) PHQ-9 score ≥ 20 during screening, for subjects in the depression subgroup.
Subjects with PHQ-9 score between 15-19 will be allowed to enroll if evaluation
by a Mental Health Professional during screening rules out severe depression;
c) Moderate to severe depression for subjects enrolling in all cohorts except for
subjects enrolling in the depression subgroup of the intolerant or ineligible cohort;
d) 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;
e) 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);
f) Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy;
g) 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);
h) 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);
i) Any gastrointestinal disease or surgical procedure that may impact the absorption of study drug. (Subjects who have had cholecystectomy are permitted to enter the study);
j) History of HIV infection;
k) Uncontrolled diabetes (any subject with a confirmed screening HgA1c ≥ 8.5 must be excluded);
l) 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);
m) Any other medical, psychiatric and/or social reason, including 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;
n) Inability to tolerate oral medication;
o) Poor venous access;
The Estimated Number of Participants
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Taiwan
72 participants
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Global
725 participants
