Clinical Trials List
Protocol NumberAI444-046
2013-09-01 - 2017-12-31
Others
Terminated1
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 Long-Term Follow-up Study of Subjects Who Participated in a Clinical Trial in which Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) was Administered for the Treatment of Chronic Hepatitis C
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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
- 陳昇弘 Digestive System Department
- 高榮達 Digestive System Department
- Hsueh-Chou Lai Digestive System Department
- 賴學州 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Hepatitis C
Objectives
To determine the durability of virologic response in subjects previously treated with asunaprevir and/or daclatasvir who achieved Sustained Virologic Response (SVR12) in the previous study.
Test Drug
NA
Active Ingredient
NA
Dosage Form
NA
Dosage
NA
Endpoints
To determine the durability of virologic response in subjects previously treated with asunaprevir and/or daclatasvir who achieved Sustained Virologic Response (SVR12) in the previous study
Inclution Criteria
Inclusion Criteria
1) Signed Written Informed Consent
a) Freely given informed consent must be obtained from subjects prior to trial participation, including informed consent for any screening procedures conducted to establish subject eligibility for the study
2) Target Population
a) Subjects must have received at least one dose of asunaprevir and/or daclatasvir and
completed participation (ie, completed the required post-treatment follow-up period) in a
previous study
i) Subjects participating in daclatasvir and/or asunaprevir studies (ie, protocol numbers
beginning with AI443, AI444 or AI447) may enroll regardless of virologic response;
in addition, subjects who received control agents (eg, placebo) in the parent trial will
be allowed to participate until unblinded treatment information is released for the
parent protocol (at that time subjects will have the option to continue in the study)
b) Must enroll in this study within 6 months of completing previous BMS study or within 6 months of protocol availability at the clinical site
3) Age and Reproductive Status
c) Men and women, ages 18 and older
1) Signed Written Informed Consent
a) Freely given informed consent must be obtained from subjects prior to trial participation, including informed consent for any screening procedures conducted to establish subject eligibility for the study
2) Target Population
a) Subjects must have received at least one dose of asunaprevir and/or daclatasvir and
completed participation (ie, completed the required post-treatment follow-up period) in a
previous study
i) Subjects participating in daclatasvir and/or asunaprevir studies (ie, protocol numbers
beginning with AI443, AI444 or AI447) may enroll regardless of virologic response;
in addition, subjects who received control agents (eg, placebo) in the parent trial will
be allowed to participate until unblinded treatment information is released for the
parent protocol (at that time subjects will have the option to continue in the study)
b) Must enroll in this study within 6 months of completing previous BMS study or within 6 months of protocol availability at the clinical site
3) Age and Reproductive Status
c) Men and women, ages 18 and older
Exclusion Criteria
Exclusion Criteria
1) Prohibited Treatments and/or Therapies
a) Subject must not have been treated with any antiviral or immunomodulatory drug for
CHC after completion of the previous study during which asunaprevir and/or daclatasvir were administered
2) Other Exclusion Criteria
a) Subject must not be participating in any other trial, excluding non-interventional trials
b) Prisoners or subjects who are involuntarily incarcerated
c) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
1) Prohibited Treatments and/or Therapies
a) Subject must not have been treated with any antiviral or immunomodulatory drug for
CHC after completion of the previous study during which asunaprevir and/or daclatasvir were administered
2) Other Exclusion Criteria
a) Subject must not be participating in any other trial, excluding non-interventional trials
b) Prisoners or subjects who are involuntarily incarcerated
c) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
The Estimated Number of Participants
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Taiwan
15 participants
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Global
1000 participants
