NCT01732354

Brief Summary

The investigators aim to clarify the issue of adequate duration of consolidation period of Chronic hepatitis B infection with antiviral treatment with Tenofovir which could strike a balance between durable HBeAg seroconversion and avoiding long-term inevitable serological or virological recurrence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

September 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2013

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2018

Completed
Last Updated

April 19, 2018

Status Verified

April 1, 2018

Enrollment Period

1.2 years

First QC Date

November 18, 2012

Last Update Submit

April 18, 2018

Conditions

Hepatitis B

Keywords

Hepatitis B virus, Tenofovir

Outcome Measures

Primary Outcomes (1)

  • HBeAg seroconversion was defined as loss of HBeAg with concurrent appearance of HBeAb.

    We aim to clarify the issue of adequate duration of consolidation period which could strike a balance between durable HBeAg seroconversion and avoiding long-term inevitable serological or virological recurrence.

    3 years

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

137 patients

You may qualify if:

  • adult patients with chronic HBV infection (HBsAg-positivity for at least six months and HBeAg-positivity for at least three months) and serum HBV DNA levels ≥1000000 copies/ml (Cobas Amplicor HBV Monitor assay) at screening as well as serum ALT levels \>1.3 times the ULN (43 IU/L) on at least two occasions in the previous 6 months and at screening.

You may not qualify if:

  • co-infection with HCV, HDV, or HIV and treatment with (pegylated) interferon or other nucleos (t) ide analogues for less than six months before the start of Tenofovir treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chun-Hsiang Wang

Tainan, 701, Taiwan

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2012

First Posted

November 22, 2012

Study Start

September 1, 2012

Primary Completion

November 20, 2013

Study Completion

April 18, 2018

Last Updated

April 19, 2018

Record last verified: 2018-04

Locations

TW(1)