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A Study of Peginterferon Alfa-2a [PEGASYS] in Patients With Chronic Hepatitis B Who Are HBeAg Positive

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Roche

Status and phase

Completed
Phase 4

Conditions

Hepatitis B, Chronic

Treatments

Drug: peginterferon alfa-2a [PEGASYS]
Drug: Adefovir

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01086085
ML22266

Details and patient eligibility

About

This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a [PEGASYS] in patients with HBeAg positive chronic hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting from week 29 of PEGASYS treatment). The anticipated time on study drug is >2 years.

Enrollment

265 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients >/=18 years of age
  • HBeAg positive chronic hepatitis B
  • Compensated liver disease

Exclusion criteria

  • Patients who had previously received treatment of drugs with activity against HBV within 6 months prior to study start
  • Antiviral, anti-neoplastic or immunomodulatory treatment
  • Co-infection with active hepatitis A, hepatitis C, hepatitis D, or HIV
  • Evidence of decompensated liver disease
  • Chronic liver disease other than viral hepatitis

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

265 participants in 4 patient groups

A
Experimental group
Treatment:
Drug: peginterferon alfa-2a [PEGASYS]
Drug: peginterferon alfa-2a [PEGASYS]
Drug: peginterferon alfa-2a [PEGASYS]
B
Experimental group
Treatment:
Drug: peginterferon alfa-2a [PEGASYS]
Drug: peginterferon alfa-2a [PEGASYS]
Drug: peginterferon alfa-2a [PEGASYS]
C
Experimental group
Treatment:
Drug: peginterferon alfa-2a [PEGASYS]
Drug: peginterferon alfa-2a [PEGASYS]
Drug: peginterferon alfa-2a [PEGASYS]
D
Experimental group
Treatment:
Drug: peginterferon alfa-2a [PEGASYS]
Drug: peginterferon alfa-2a [PEGASYS]
Drug: peginterferon alfa-2a [PEGASYS]
Drug: Adefovir

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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