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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Entecavir in Treatment-Naive Patients With HBeAg-Positive Chronic Hepatitis B.

NCT00614471 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2016-11-02

No results posted yet for this study

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.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Entecavir

0.5mg po daily for 24 weeks

DRUG

Entecavir

0.5mg po daily from week 13 to week 36

DRUG

peginterferon alfa-2a [Pegasys]

180 micrograms sc/week for 48 weeks

DRUG

peginterferon alfa-2a [Pegasys]

180 micrograms sc/week from week 21 to week 68

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • China
  • Hong Kong

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00614471 on ClinicalTrials.gov