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

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: 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 single arm study will evaluate the efficacy and safety of PEGASYS in treatment-naive Baltic patients with HBeAg-positive chronic HBV. All patients will receive PEGASYS 180 micrograms s. c. once weekly. Following 48 weeks of treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Clinical Details

Official title: An Open Label Study Evaluating Safety and the Effect of PEGASYSŪ on HBV DNA Levels in Patients With HBeAg-positive and HBeAg-negative Chronic Hepatitis B

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

Primary outcome: Number of patients with HBV DNA <100,000 copies/mL

Secondary outcome:

HBV DNA <400 copies/mL, HBsAg seroconversion, ALT normalization, sustained HBe seroconversion.

AEs, laboratory parameters.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- adult patients, 18-70 years of age;

- HBeAg positive, HBsAg positive for >=6 months;

- anti-HBs negative;

- HBV DNA >500,000 copies/mL.

Exclusion Criteria:

- previous antiviral or interferon-based therapy for CHB;

- evidence of decompensated liver disease;

- chronic liver disease other than viral hepatitis;

- co-infection with active hepatitis A, C or D virus;

- co-infection with human immunodeficiency virus (HIV).

Locations and Contacts

Tallinn 10138, Estonia

Tallinn 10617, Estonia

Tartu 51014, Estonia

Riga 1006, Latvia

Kaunas 47144, Lithuania

Kaunas 50009, Lithuania

Klaipeda 92288, Lithuania

Vilnius 08117, Lithuania

Vilnius 08661, Lithuania

Additional Information

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

Page last updated: August 23, 2015

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