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

A Randomized, Open Label Study of the Effect of Peginterferon Alfa-2a (40KD) (PEGASYS®) Plus Entecavir (Baraclude®) Combination Therapy on Quantitative Changes in HBeAg in Treatment-naive Patients With HBeAg Positive Chronic Hepatitis B

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00614471

Enrollment

219

Registered

2008-02-13

Start date

2007-08-31

Completion date

2009-10-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

Brief 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.

Interventions

DRUGEntecavir

0.5mg po daily for 24 weeks

DRUGpeginterferon alfa-2a [Pegasys]

180 micrograms sc/week for 48 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* adult patients, 18-65 years of age; * HBsAg positive, HBeAg positive and anti-HBe negative for at least 6 months, anti-HBs negative; * absence of cirrhosis confirmed by liver biopsy in previous 12 months.

Exclusion criteria

* previous treatment for chronic hepatitis B within previous 6 months; * antiviral, anti-neoplastic or immunomodulatory treatment in previous 6 months; * co-infection with active hepatitis A, hepatitis C, hepatitis D or HIV; * history or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis.

Design outcomes

Primary

Measure	Time frame
Log change in quantitative HBeAg from baseline to 24 weeks after end of treatment.	Week 72 for Arms 1 and 2. Week 92 for Arm 3.

Secondary

Measure	Time frame
HBeAg seroconversion, HBV-DNA <1000 copies/mL, loss of HBeAg, HBV DNA reduction, ALT normalization, loss of HBsAg seroconversion, reduction of HBsAg 24 weeks after end of treatment.	Week 72 for Arms 1 and 2. Week 92 for Arm 3.
AEs, laboratory parameters.	Throughout study

Countries

China, Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026