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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B, Chronic

Intervention: Adefovir (Drug); Entecavir (Drug); Placebo (Drug); peginterferon alfa-2a [Pegasys] (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

This 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly for 48 weeks + placebo from

weeks - 4 to 2;2)PEGASYS 180 micrograms sc weekly for 48 weeks + Adefovir from weeks -4 to

2; or 3)PEGASYS 180 micrograms sc weekly for 48 weeks + Entecavir from weeks - 4 to 2.

Treatment will be followed by 24 weeks of treatment-free follow-up. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.

Clinical Details

Official title: A Randomized, Open-label Study of the Effect of Peginterferon Alfa-2a (40KD)(PEGASYS) in Combination With Adefovir or Entecavir on HBeAg Seroconversion in Patients With HBeAg Positive Chronic Hepatitis B

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: HBeAg seroconversion

Secondary outcome:

HBV DNA; loss of HBeAg; ALT normalization

HbsAg measurement

Adverse events, vital signs, laboratory parameters

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- adult patients, 18-65 years of age;

- HBeAg+ve for >=3 months;

- positive serum HBV DNA within 3 months prior to entry;

- patients with chronic hepatitis B, either naive to HBV treatment, or not

responded/relapsed to nucleoside analogues;

- >=3 months treatment-free interval from nucleotide analogues.

Exclusion Criteria:

- evidence of decompensated liver disease;

- history or other evidence of a medical condition associated with chronic liver

disease othr than viral hepatitis;

- co-infection with active hepatitis A,C or D, or HIV.

Locations and Contacts

Changhua 500, Taiwan

Kaohsiung 00833, Taiwan

Kaohsiung 807, Taiwan

Keelung City 204, Taiwan

Taichung 404, Taiwan

Taipei 100, Taiwan

Taipei 112, Taiwan

Taipei, Taiwan

Taoyuan 333, Taiwan

Additional Information

Starting date: May 2010
Last updated: August 17, 2015

Page last updated: August 23, 2015

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