NCT02598063

Brief Summary

This study will evaluate the efficacy and safety of peginterferon alfa-2a or ADV, in participants with lamivudine-resistant HBeAg-positive chronic hepatitis B. Participants will be randomized to receive either peginterferon alfa-2a for 48 weeks in combination with oral lamivudine for the first 12 weeks, or ADV for 72 weeks in combination with oral lamivudine for the first 12 weeks. The anticipated time on study treatment is 72 weeks, and the target sample size is 255 individuals.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
255

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_4

Geographic Reach
2 countries

12 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
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
Last Updated

February 2, 2016

Status Verified

February 1, 2016

Enrollment Period

3.5 years

First QC Date

November 4, 2015

Last Update Submit

February 1, 2016

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

  • HBeAg seroconversion (defined as loss of HBeAg and presence of anti-HBe) at Week 72

    Week 72

Secondary Outcomes (4)

  • Loss of HBeAg

    Week 48, and 72

  • Reduction in hepatitis B virus deoxyribonucleic acid (HBV DNA)

    Week 48, and 72

  • Alanine transaminase (ALT) normalization

    Week 48, and 72

  • Hepatitis B surface antigen (HBsAg) seroconversion

    Week 48, and 72

Study Arms (2)

ADV + Lamivudine

ACTIVE COMPARATOR

Participants will receive ADV and lamivudine tablets at a dose of 10 mg orally QD for first 12 weeks followed by ADV for 60 weeks.

Drug: Adefovir dipivoxilDrug: Lamivudine

Peginterferon alfa-2a + Lamivudine

EXPERIMENTAL

Participants will receive peginterferon alfa-2a injection at a dose of 180 micrograms (mcg) once weekly (QW) and 100 milligrams (mg) lamivudine tablets orally once daily (QD) for first 12 weeks followed by peginterferon alfa-2a for 36 weeks.

Drug: LamivudineDrug: Peginterferon alfa-2a

Interventions

Adefovir dipivoxilDRUG

ADV will be administered orally at a dose of 10 mg QD for 72 weeks.

ADV + Lamivudine
LamivudineDRUG

Lamivudine tablets will be administered orally at a dose of 10 mg QD for 12 weeks.

ADV + LamivudinePeginterferon alfa-2a + Lamivudine
Peginterferon alfa-2aDRUG

Peginterferon alfa-2a injection will be administered at a dose of 180 mcg QW for 48 weeks.

Also known as: Pegasys
Peginterferon alfa-2a + Lamivudine

Eligibility Criteria

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

You may qualify if:

  • Adult participants 18-65 years of age
  • Hepatitis B surface antigen (HBsAg)-positive, HBeAg-positive, and anti-HBs-negative for greater than or equal to (\>=) 6 months
  • Receiving lamivudine currently, and for \>=6 months
  • hepatitis B virus (HBV)-deoxyribonucleic acid (DNA) decreased \>=2 log during lamivudine treatment on \>=1 occasion
  • Absence of cirrhosis confirmed by liver biopsy in previous 6 months

You may not qualify if:

  • Other drugs with activity against HBV within the prior 6 months, except lamivudine
  • Antiviral, anti-neoplastic, or immunomodulatory therapy less than or equal to (\<=) 6 months before study - Active infection with hepatitis A, C, or D virus, or human immunodeficiency virus
  • Decompensated liver disease
  • Medical condition associated with another chronic liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Beijing, 100044, China

Location

Unknown Facility

Beijing, 100050, China

Location

Unknown Facility

Beijing, 100054, China

Location

Unknown Facility

Chongqing, 400038, China

Location

Unknown Facility

Guangzhou, 510515, China

Location

Unknown Facility

Hangzhou, 310003, China

Location

Unknown Facility

Jinan, 250021, China

Location

Unknown Facility

Shanghai, 200025, China

Location

Unknown Facility

Shanghai, 200040, China

Location

Unknown Facility

Shanghai, 201508, China

Location

Unknown Facility

Hong Kong, 852, Hong Kong

Location

Unknown Facility

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

adefovir dipivoxilLamivudinepeginterferon 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

Intervention Hierarchy (Ancestors)

ZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosides

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY CHAIR

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

November 4, 2015

First Posted

November 5, 2015

Study Start

October 1, 2005

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

February 2, 2016

Record last verified: 2016-02

Locations

HK(2)CN(10)