Hepatitis BNCT01863589
Drug Use Investigation for HEPSERA (Adefovir) Tablet
An observational study of Hepatitis B, run by GlaxoSmithKline.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Adefovir tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 436 participants
- Where
- No sites listed yet
- Study dates
- Feb 2005to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with chronic hepatitis B or hepatic cirrhosis B who are confirmed of hepatic function abnormality with continuous re-proliferation of hepatitis B virus while treated with lamivudine
Who may be able to join
- Subjects with chronic hepatitis B or hepatic cirrhosis B
- Subjects treated with adefovir tablets
Who cannot join
- None
About this study
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.
- Conditions
- Hepatitis B
- Being tested
- Adefovir tablets
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adefovir tabletsDrug
Administered according to the prescribing information in the locally approved label by the authorities.
| Study group | Role | What they receive |
|---|---|---|
| Subjects prescribed adefovir tablets | Subjects with chronic hepatitis B or hepatic cirrhosis B to whom adefovir tablets are administered Receives: Drug: Adefovir tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse drug reactions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startFeb 2005
- Primary completionJun 2007
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 436 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863589
- Sponsor's protocol ID
- 112299
- Status last verified
- May 2013
- First submitted
- 4 Oct 2012
- Last updated
- 29 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation for HEPSERA (Adefovir) Tablet
- ClinicalTrials.gov ID
- NCT01863589
- Acronym / sponsor ID
- 112299
- Conditions
- Hepatitis B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 436 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 29 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects prescribed adefovir tablets | – | Drug: Adefovir tabletsSubjects with chronic hepatitis B or hepatic cirrhosis B to whom adefovir tablets are administered |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with chronic hepatitis B or hepatic cirrhosis B who are confirmed of hepatic function abnormality with continuous re-proliferation of hepatitis B virus while treated with lamivudine
Key inclusion criteria (2 listed)
- Subjects with chronic hepatitis B or hepatic cirrhosis B
- Subjects treated with adefovir tablets
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adefovir tabletsAdministered according to the prescribing information in the locally approved label by the authorities. | Drug | Subjects prescribed adefovir tablets |
Primary outcome
The incidence of adverse drug reactions
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of adverse drug reactions (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2013.