NCT00460850

Brief Summary

This single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180 micrograms s.c. weekly for 48 weeks; following this, there will be a 48 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

4 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

June 30, 2008

Status Verified

June 1, 2008

First QC Date

April 16, 2007

Last Update Submit

June 27, 2008

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

  • Normalization of ALT, and HBV-DNA <10,000 copies/mL

    Week 96

Secondary Outcomes (3)

  • Normalization of ALT, and HBV-DNA <10,000 copies/mL

    Weeks 48 and 72

  • HBsAg loss and anti-HBs seroconversion

    Weeks 48, 72 and 96

  • AEs and lab parameters

    Throughout study

Study Arms (1)

1

EXPERIMENTAL
Drug: peginterferon alfa-2a (40KD) [PEGASYS]

Interventions

peginterferon alfa-2a (40KD) [PEGASYS]DRUG

180 micrograms sc weekly for 48 weeks

1

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;
  • HBeAg negative chronic hepatitis B;
  • treated with lamivudine for \>=6 months;
  • demonstrated lamivudine resistance;
  • compensated liver disease.

You may not qualify if:

  • severe hepatic dysfunction;
  • previous treatment with antivirals other than lamivudine;
  • immunosuppressant treatment in past 6 months;
  • co-infection with hepatitis A, C, or D virus or human immunodeficiency virus;
  • medical condition associated with chronic liver disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Ankara, 06620, Turkey (Türkiye)

Location

Unknown Facility

Antalya, 07058, Turkey (Türkiye)

Location

Unknown Facility

Istanbul, 34390, Turkey (Türkiye)

Location

Unknown Facility

Izmir, 35360, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon 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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 16, 2007

First Posted

April 17, 2007

Study Start

September 1, 2007

Study Completion

June 1, 2008

Last Updated

June 30, 2008

Record last verified: 2008-06

Locations

TU(4)