Special Drug Use Investigation for ZEFIX (Lamivudine) Tablet (HBV Cirrhosis)
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT01376154
Collaborator
(none)
342
56
Study Details
Study Description
Brief Summary
The purpose of this study is to confirm efficacy and safety when administering lamivudine tablet alone in subjects with hepatitis B virus-induced liver cirrhosis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
342 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Special Drug Use Investigation for ZEFIX (Lamivudine) Tablet (HBV Cirrhosis)
Study Start Date
:
Jun 1, 2006
Actual Primary Completion Date
:
Dec 1, 2009
Actual Study Completion Date
:
Feb 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Subjects prescribed lamivudine tablet Subjects with hepatitis B virus-induced liver cirrhosis prescribed lamivudine tablet during study period |
Drug: Lamivudine
|
Outcome Measures
Primary Outcome Measures
- Number of adverse events in Japanese subjects with hepatitis B virus-induced liver cirrhosis treated with lamivudine tablet [6 months or more]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Subjects with hepatitis B virus-induced liver cirrhosis, in whom lamivudine tablet was administered alone for 6 months or longer, or those in whom lamivudine tablet was expected to be administered alone for 6 months or longer
Exclusion Criteria:
-
Subjects previously enrolled in Drug Use Investigation or Special Drug Use Investigation of lamivudine tablet
-
Subjects with a history of hypersensitivity of the ingredients of lamivudine tablet
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01376154
Other Study ID Numbers:
- 112335
First Posted:
Jun 20, 2011
Last Update Posted:
May 22, 2017
Last Verified:
May 1, 2017