NCT00614471

Brief Summary

This 3 arm study will assess the efficacy and safety of PEGASYS + entecavir combination therapy in treatment-naive patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms s.c./week for 48 weeks, 2)PEGASYS 180 micrograms s.c./week for 48 weeks + entecavir 0.5mg p.o. once daily from week 13 to week 36 or 3) entecavir 0.5mg p.o. once daily for 24 weeks + PEGASYS 180 micrograms s.c./week from week 21 to 68. Treatment will be followed by 24 weeks treatment-free follow up. The anticipated time on study treatment is 3-12 months for groups 1 and 2, and 1-2 years for group 3, and the target sample size is 100-500 individuals.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
219

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2007

Typical duration for phase_4

Geographic Reach
2 countries

8 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

Study Start

First participant enrolled

August 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2.2 years

First QC Date

January 30, 2008

Last Update Submit

November 1, 2016

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

  • Log change in quantitative HBeAg from baseline to 24 weeks after end of treatment.

    Week 72 for Arms 1 and 2. Week 92 for Arm 3.

Secondary Outcomes (2)

  • HBeAg seroconversion, HBV-DNA <1000 copies/mL, loss of HBeAg, HBV DNA reduction, ALT normalization, loss of HBsAg seroconversion, reduction of HBsAg 24 weeks after end of treatment.

    Week 72 for Arms 1 and 2. Week 92 for Arm 3.

  • AEs, laboratory parameters.

    Throughout study

Study Arms (3)

1

ACTIVE COMPARATOR
Drug: peginterferon alfa-2a [Pegasys]

2

EXPERIMENTAL
Drug: EntecavirDrug: peginterferon alfa-2a [Pegasys]

3

EXPERIMENTAL
Drug: EntecavirDrug: peginterferon alfa-2a [Pegasys]

Interventions

EntecavirDRUG

0.5mg po daily for 24 weeks

3
peginterferon alfa-2a [Pegasys]DRUG

180 micrograms sc/week for 48 weeks

12

Eligibility Criteria

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

You may qualify if:

  • adult patients, 18-65 years of age;
  • HBsAg positive, HBeAg positive and anti-HBe negative for at least 6 months, anti-HBs negative;
  • absence of cirrhosis confirmed by liver biopsy in previous 12 months.

You may not qualify if:

  • previous treatment for chronic hepatitis B within previous 6 months;
  • antiviral, anti-neoplastic or immunomodulatory treatment in previous 6 months;
  • co-infection with active hepatitis A, hepatitis C, hepatitis D or HIV;
  • history or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Beijing, 100011, China

Location

Unknown Facility

Hangzhou, 310003, China

Location

Unknown Facility

Shanghai, 200021, China

Location

Unknown Facility

Shanghai, 200025, China

Location

Unknown Facility

Shanghai, 200235, China

Location

Unknown Facility

Xi'an, 710038, China

Location

Unknown Facility

Zhengzhou, 450052, China

Location

Unknown Facility

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Xie Q, Zhou H, Bai X, Wu S, Chen JJ, Sheng J, Xie Y, Chen C, Chan HL, Zhao M. A randomized, open-label clinical study of combined pegylated interferon Alfa-2a (40KD) and entecavir treatment for hepatitis B "e" antigen-positive chronic hepatitis B. Clin Infect Dis. 2014 Dec 15;59(12):1714-23. doi: 10.1093/cid/ciu702. Epub 2014 Sep 4.

    PMID: 25190434DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavirpeginterferon 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

January 30, 2008

First Posted

February 13, 2008

Study Start

August 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

CN(7)HK(1)