NCT01863589

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
436

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2005

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2012

Completed
8 months until next milestone

First Posted

Study publicly available on registry

May 29, 2013

Completed
Last Updated

May 29, 2013

Status Verified

May 1, 2013

Enrollment Period

2.3 years

First QC Date

October 4, 2012

Last Update Submit

May 23, 2013

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • The incidence of adverse drug reactions

    1 year

Study Arms (1)

Subjects prescribed adefovir tablets

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

Drug: Adefovir tablets

Interventions

Adefovir tabletsDRUG

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

Subjects prescribed adefovir tablets

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis B

Interventions

adefovir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2012

First Posted

May 29, 2013

Study Start

February 1, 2005

Primary Completion

June 1, 2007

Study Completion

July 1, 2012

Last Updated

May 29, 2013

Record last verified: 2013-05