CClinicalTrials.gg
CompletedNCT01863589Updated May 29, 2013

Drug Use Investigation for HEPSERA (Adefovir) Tablet

An observational study in Hepatitis B, sponsored by GlaxoSmithKline. Completed. Per ClinicalTrials.gov, last updated 2013-05-29.

Sponsored by GlaxoSmithKline · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
436
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatitis B

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03

In context

Hepatitis B

1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.

This study's enrollment of 436 is above the median of 390 across 407 observational studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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

Inclusion criteria

  • Subjects with chronic hepatitis B or hepatic cirrhosis B
  • Subjects treated with adefovir tablets

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Time perspective
Prospective
Enrollment
436 participants (actual)

Groups and cohorts

  • Subjects prescribed adefovir tablets

    Subjects with chronic hepatitis B or hepatic cirrhosis B to whom adefovir tablets are administered

    Drug: Adefovir tablets

Interventions

  • DrugAdefovir tablets

    Administered according to the prescribing information in the locally approved label by the authorities.

06

What researchers measure

Primary outcomes

  1. The incidence of adverse drug reactions

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01863589
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
May 29, 2013
Start date
Feb 2005
Primary completion
Jun 2007
Completion
Jul 2012
Last update
May 29, 2013

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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