NCT01599130

Brief Summary

For HBeAg (+) hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In the investigators study, patients were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 8, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 15, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

1.8 years

First QC Date

May 8, 2012

Last Update Submit

May 14, 2012

Conditions

Hepatitis B

Keywords

Hepatitis Bsequential peg-interferon-2a to entecavir

Outcome Measures

Primary Outcomes (1)

  • HBeAg sericonversion rate

    72 weeks

Secondary Outcomes (6)

  • HBeAg loss rate

    72 weeks

  • HBeAg quantification dynamic change

    72 weeks

  • HBsAg loss rate

    72 weeks

  • HBsAg seroconversion rate

    72 weeks

  • HBsAg quantification dynamic change

    72 weeks

  • +1 more secondary outcomes

Study Arms (2)

entecavir

ACTIVE COMPARATOR

patients continue to use entecavir

Drug: Entecavir

peg-interferon

EXPERIMENTAL

patients switch to sequential peg-interferon α-2a

Drug: Peginterferon alfa-2a

Interventions

EntecavirDRUG

entecavir 0.5mg per day

Also known as: Baraclude
entecavir
Peginterferon alfa-2aDRUG

Peginterferon alfa-2a 180ug per week

Also known as: Pagasys
peg-interferon

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 50 years old
  • HBsAg(+) and HBeAg(+) for over 6 months before entecavir treatment
  • Treated by entacavir for 48 weeks with HBeAg seroconversion

You may not qualify if:

  • Pregnant women
  • Decompensated liver disease
  • Combination infection of HCV, HAV, or HEV
  • Combination infection of HIV
  • Any contraindication of interferon α

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Affliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

entecavirpeginterferon alfa-2a

Condition Hierarchy (Ancestors)

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

Study Officials

  • Zhiliang Gao

    The Third Affliated Hospital of Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 8, 2012

First Posted

May 15, 2012

Study Start

July 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

May 15, 2012

Record last verified: 2012-05

Locations

CN(1)