CompletedPhase 4

A Study of Peginterferon Alfa-2a (Pegasys) in Participants With Hepatitis B E-Antigen (HBeAg)-Positive Chronic Hepatitis B Virus (HBV)

China307 participantsStarted 2003-11

Plain-language summary

This is a study of the efficacy and safety of peginterferon alfa-2a (Pegasys) in naive, interferon- or lamivudine-pretreated participants with HBeAg-positive chronic HBV. Following 48 weeks 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 100-500 individuals.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult participants between 18 to 65 years of age * HBeAg-positive chronic HBV * Treatment-naive, or have received and have not responded to or have relapsed on either conventional interferon or lamivudine therapy. Exclusion Criteria: * Antiviral or interferon-based therapy for chronic HBV within 6 months of enrollment * Co-infection with active hepatitis A, C or D virus or with human immunodeficiency virus (HIV) * Evidence of decompensated liver disease * Medical condition associated with chronic liver disease other than viral hepatitis.

What they're measuring

Percentage of participants with HBV deoxyribonucleic acid (DNA) less than (<) 100,000 copies per milliliters (copies/mL)

Timeframe: 72 weeks

Percentage of participants with HBeAg seroconversion

Timeframe: 72 weeks

Trial details

NCT IDNCT02604823

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-11

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