NCT01086085

Brief Summary

This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a \[PEGASYS\] in patients with HBeAg positive chronic hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting from week 29 of PEGASYS treatment). The anticipated time on study drug is \>2 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
265

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2010

Typical duration for phase_4

Geographic Reach
1 country

11 active sites

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

First Submitted

Initial submission to the registry

March 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2010

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2.9 years

First QC Date

March 11, 2010

Last Update Submit

November 1, 2016

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

  • Efficacy: Quantitative HBsAG reduction (proportion of patients with HBsAG reduction)

    Weeks 72, 96, 120

Secondary Outcomes (2)

  • Proportion of patients achieving HBeAG seroconversion and HBV DNA </=100000 copies/ml

    Weeks 24, 48, 72, 96, 120

  • Safety: Adverse Events

    From baseline to Week 120

Study Arms (4)

A

EXPERIMENTAL
Drug: peginterferon alfa-2a [PEGASYS]

B

EXPERIMENTAL
Drug: peginterferon alfa-2a [PEGASYS]

C

EXPERIMENTAL
Drug: peginterferon alfa-2a [PEGASYS]

D

EXPERIMENTAL
Drug: AdefovirDrug: peginterferon alfa-2a [PEGASYS]

Interventions

AdefovirDRUG

Adefovir 10 mg po once daily for 36 weeks

D
peginterferon alfa-2a [PEGASYS]DRUG

Early responders: PEGASYS 180 mcg sc once weekly for 48 weeks

A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients \>/=18 years of age
  • HBeAg positive chronic hepatitis B
  • Compensated liver disease

You may not qualify if:

  • Patients who had previously received treatment of drugs with activity against HBV within 6 months prior to study start
  • Antiviral, anti-neoplastic or immunomodulatory treatment
  • Co-infection with active hepatitis A, hepatitis C, hepatitis D, or HIV
  • Evidence of decompensated liver disease
  • Chronic liver disease other than viral hepatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Beijing, 100011, China

Location

Unknown Facility

Beijing, 100034, China

Location

Unknown Facility

Beijing, 100044, China

Location

Unknown Facility

Beijing, 100050, China

Location

Unknown Facility

Changchun, 130021, China

Location

Unknown Facility

Guangzhou, 510515, China

Location

Unknown Facility

Shanghai, 200025, China

Location

Unknown Facility

Shanghai, 200040, China

Location

Unknown Facility

Shanghai, 200433, China

Location

Unknown Facility

Wuhan, 430030, China

Location

Unknown Facility

Xi'an, 710038, China

Location

Related Publications (1)

  • Sun J, Ma H, Xie Q, Xie Y, Sun Y, Wang H, Shi G, Wan M, Niu J, Ning Q, Yu Y, Zhou H, Cheng J, Kang W, Xie Y, Fan R, Wei L, Zhuang H, Jia J, Hou J. Response-guided peginterferon therapy in patients with HBeAg-positive chronic hepatitis B: A randomized controlled study. J Hepatol. 2016 Oct;65(4):674-682. doi: 10.1016/j.jhep.2016.05.024. Epub 2016 May 26.

    PMID: 27238752DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

adefovirpeginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2010

First Posted

March 12, 2010

Study Start

April 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

CN(11)