Last updated: 11/07/2018 04:44:18
Special Drug Use Investigation for ZEFIX (lamivudine) tablet (HBV Cirrhosis)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Special Drug Use Investigation for ZEFIX (lamivudine) tablet (HBV Cirrhosis)
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of adverse events in Japanese subjects with hepatitis B virus-induced liver cirrhosis treated with lamivudine tablet
Timeframe: 6 months or more
Secondary outcomes:
Not applicable
Interventions:
Drug: Lamivudine
Enrollment:
342
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Other
Clinical publications:
Atsuko Ishida, Yuki Saito, Hideyuki Okano, Terufumi Hara, Pascal Yoshida. Assessment of Safety and Efficacy of Lamivudine Tablets (Zefix® Tablets) Alone in Patients with Type B Cirrhosis Results of Special Drug Use Investigation for Long-Term Use. J Clin Therapeut Med. 2013;29(2):161-175.
Medical condition
Hepatitis B, Chronic
Product
adefovir, adefovir/lamivudine, lamivudine
Collaborators
Not applicable
Study date(s)
June 2006 to January 2012
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
No
- 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
- 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
Inclusion and exclusion criteria
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
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2012-20-01
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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