Study of Daclatasvir-based Therapy in Chinese Participants With Chronic Hepatitis C (CHC)
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Terminated
CT.gov ID
NCT03500562
Collaborator
(none)
3
2
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Study Details
Study Description
Brief Summary
Study is a non-interventional, prospective, multicenter post marketing surveillance study to determine the safety of daclatasvir based therapy
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
3 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Daclatasvir-Based Therapy Safety Surveillance in Chinese Patients With Chronic Hepatitis C
Actual Study Start Date
:
May 8, 2018
Actual Primary Completion Date
:
Mar 29, 2019
Actual Study Completion Date
:
Mar 29, 2019
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
HCV participant population in China
|
Outcome Measures
Primary Outcome Measures
- Number of adverse events (AEs) [Approximately 72 weeks]
- Number of serious adverse events (SAEs) [Approximately 72 weeks]
Secondary Outcome Measures
- Number of participants who discontinue therapy due to an AE [Approximately 72 weeks]
- Effectiveness of daclatasvir DCV-based therapy [Approximately 72 weeks]
As measured by Sustained virologic response 12 weeks after the end of treatment (SVR12) Achieved SVR12: Hepatitis C virus (HCV) RNA below the lower limit of quantification (LLOQ)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Participants 18 years of age and older
-
Participants with Chronic Hepatitis C virus (CHC) who are eligible for treatment with branded DCV-based therapy as indicated in the locally approved label
Exclusion Criteria:
- Participants under the age of 18
Other protocol defined inclusion/exclusion criteria could apply
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Local Institution | Beijing | Beijing | China | 100054 |
2 | Local Institution | Guangzhou | Guangdong | China | 510515 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT03500562
Other Study ID Numbers:
- AI444-396
First Posted:
Apr 18, 2018
Last Update Posted:
Sep 1, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: