NCT02604823

Brief Summary

This is a study of the efficacy and safety of peginterferon alfa-2a (Pegasys) in naive, interferon- or lamivudine-pretreated participants with HBeAg-positive chronic HBV. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
307

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2003

Geographic Reach
1 country

3 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

November 1, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
10 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

November 4, 2015

Last Update Submit

November 1, 2016

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (2)

  • Percentage of participants with HBV deoxyribonucleic acid (DNA) less than (<) 100,000 copies per milliliters (copies/mL)

    72 weeks

  • Percentage of participants with HBeAg seroconversion

    72 weeks

Secondary Outcomes (6)

  • Number of participants who achieved HBV DNA levels below limit of detection

    Weeks 48 and 72

  • Number of participants with HBsAg loss

    Weeks 48 and 72

  • Number of participants with both Hepatitis B Surface Antigen (HBsAg) loss and presence of Anti-HBs

    Weeks 48 and 72

  • Number of participants with alanine aminotransferase (ALT) normalization

    Weeks 48 and 72

  • Number of participants with combined response (HBV DNA <100,000 copies/mL, HBeAg loss, and ALT normalization)

    Weeks 48 and 72

  • +1 more secondary outcomes

Study Arms (3)

Group A (Naïve Participants)

EXPERIMENTAL

Participants who never received any HBV treatment, will receive peginterferon alfa-2a (180 micrograms \[mcg\]) subcutaneously once weekly for 48 weeks.

Drug: Peginterferon alfa-2a

Group B (Conventional Interferon Pretreated Participants)

EXPERIMENTAL

Participants who received conventional interferon treatment and had relapse or did not respond, will receive peginterferon alfa-2a (180 mcg) subcutaneously once weekly for 48 weeks.

Drug: Peginterferon alfa-2a

Group C (Lamivudine Pretreated Participants)

EXPERIMENTAL

Participants who received lamivudine and had relapse or did not respond, will receive peginterferon alfa-2a (180 mcg) subcutaneously once weekly for 48 weeks.

Drug: Peginterferon alfa-2a

Interventions

Peginterferon alfa-2aDRUG

Peginterferon alfa-2a will be administered at a dose of 180 mcg subcutaneously once weekly for 48 weeks.

Also known as: Pegasys
Group A (Naïve Participants)Group B (Conventional Interferon Pretreated Participants)Group C (Lamivudine Pretreated Participants)

Eligibility Criteria

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

You may qualify if:

  • Adult participants between 18 to 65 years of age
  • HBeAg-positive chronic HBV
  • Treatment-naive, or have received and have not responded to or have relapsed on either conventional interferon or lamivudine therapy.

You may not qualify if:

  • Antiviral or interferon-based therapy for chronic HBV within 6 months of enrollment
  • Co-infection with active hepatitis A, C or D virus or with human immunodeficiency virus (HIV)
  • Evidence of decompensated liver disease
  • Medical condition associated with chronic liver disease other than viral hepatitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Beijing, 100011, China

Location

Unknown Facility

Guangzhou, 510630, China

Location

Unknown Facility

Shanghai, 200025, China

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 CHAIR

Study Design

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

Study Record Dates

First Submitted

November 4, 2015

First Posted

November 13, 2015

Study Start

November 1, 2003

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

CN(3)