Last updated: 11/07/2018 04:39:27
Drug Use Investigation for HEPSERA (adefovir) Tablet
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Drug Use Investigation for HEPSERA (adefovir) Tablet
Trial description: This post-marketing surveillance (PMS) is conducted to collect safety and efficacy data among subjects with chronic hepatitis B and hepatic cirrhosis B who is treated with adefovir tablets.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The incidence of adverse drug reactions
Timeframe: 1 year
Secondary outcomes:
Not applicable
Interventions:
Drug: Adefovir tablets
Enrollment:
436
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Atsuko Ishida,Terufumi Hara,Pascal Yoshida.A Drug Use Investigation to Monitor the Improvement Effect of Hepatic Function and Safety of Adefovir (Hepsera®) Tablets in Patients with Hepatitis B Virus-related Liver Disease (Final Results).J Clin Therapeut Med.2014;30(5):415-428
Medical condition
Hepatitis B
Product
adefovir, lamivudine
Collaborators
Not applicable
Study date(s)
February 2005 to September 2012
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
No
- Subjects with chronic hepatitis B or hepatic cirrhosis B
- Subjects treated with adefovir tablets
- None
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects with chronic hepatitis B or hepatic cirrhosis B
- Subjects treated with adefovir tablets
Exclusion criteria:
- None
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
2012-28-09
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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