NCT01519921

Brief Summary

This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180 micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2005

Typical duration for phase_4

Geographic Reach
1 country

7 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

October 1, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
4 years until next milestone

Results Posted

Study results publicly available

January 25, 2016

Completed
Last Updated

April 21, 2016

Status Verified

March 1, 2016

Enrollment Period

2.7 years

First QC Date

January 5, 2012

Results QC Date

December 17, 2015

Last Update Submit

March 22, 2016

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants With Hepatitis B Virus DNA <100,000 Copies/mL At Week 72

    Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (EOF) period (24 weeks after the end of treatment) were classified as responders.

    Week 72

  • Percentage of Participants With Hepatitis B Virus e Antigen Loss At Week 72

    Participants with loss of hepatitis B virus e antigen (HBeAg) at the EOF period (24 weeks after the end of treatment) were classified as responders.

    Week 72

Secondary Outcomes (7)

  • Percentage of Participants With ALT Normalization At Week 48 and Week 72

    Week 48 and Week 72

  • Percentage of Participants With Hepatitis B Virus DNA Below the Limit of Detection At Week 48 and Week 72

    Week 48 and Week 72

  • Percentage of Participants With a Combined Response At Week 48 and Week 72

    Week 48 and Week 72

  • Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion

    Week 48 and Week 72

  • Percentage of Participants With Loss of Hepatitis B Surface Antigen At Week 48 and Week 72

    Week 48 and Week 72

  • +2 more secondary outcomes

Study Arms (2)

PEG-IFN alfa-2a (Treatment naïve)

EXPERIMENTAL

Eligible treatment naïve participants received peginterferon alfa-2a (PEGASYS) 180 micrograms (mcg) subcutaneously (SC) once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.

Drug: peginterferon alfa-2a [Pegasys]

PEG-IFN alfa-2a (YMDD mutant)

EXPERIMENTAL

Eligible tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.

Drug: peginterferon alfa-2a [Pegasys]

Interventions

peginterferon alfa-2a [Pegasys]DRUG

Peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once a week for 48 weeks

PEG-IFN alfa-2a (Treatment naïve)PEG-IFN alfa-2a (YMDD mutant)

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 +ve for more than 6 months, HBeAg +ve, AntiHBs -ve
  • Detectable hepatitis B virus (HBV) DNA (\>100,000 copies/mL)

You may not qualify if:

  • Coinfection with hepatitis A, hepatitis C or human immunodeficiency virus (HIV)
  • Evidence of decompensated liver disease
  • A medical condition associated with chronic liver disease other than viral hepatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Busan, 49241, South Korea

Location

Unknown Facility

Daegu, 41944, South Korea

Location

Unknown Facility

Seoul, 03722, South Korea

Location

Unknown Facility

Seoul, 05505, South Korea

Location

Unknown Facility

Seoul, 06351, South Korea

Location

Unknown Facility

Seoul, 08308, South Korea

Location

Unknown Facility

Seoul, 14647, South Korea

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

Results Point of Contact

Title
Roche Trial Information Hotline
Organization
F. Hoffmann-La Roche AG
global.trial_information@roche.com
+41 616878333

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

January 5, 2012

First Posted

January 27, 2012

Study Start

October 1, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

April 21, 2016

Results First Posted

January 25, 2016

Record last verified: 2016-03

Locations

KR(7)