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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Entecavir in Treatment-Naive 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: Entecavir (Drug); Entecavir (Drug); peginterferon alfa-2a [Pegasys] (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 + 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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Log change in quantitative HBeAg from baseline to 24 weeks after end of treatment.

Secondary outcome:

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.

AEs, laboratory parameters.

Eligibility

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

Criteria:

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.

Locations and Contacts

Beijing 100011, China

Hangzhou 310003, China

Shanghai 200021, China

Shanghai 200025, China

Shanghai 200235, China

Xi'an 710038, China

Zhengzhou 450052, China

Hong Kong, Hong Kong

Additional Information

Starting date: August 2007
Last updated: August 17, 2015

Page last updated: August 23, 2015

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