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Completed

NCT Number: NCT02604823

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

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.

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Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peginterferon alfa-2a

Drug

Peginterferon alfa-2a will be administered at a dose of 180 mcg subcutaneously once weekly for 48 weeks.

Other names: Pegasys

Primary outcomes

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

    Time frame: 72 weeks

  2. Percentage of participants with HBeAg seroconversion

    Time frame: 72 weeks

Secondary outcomes

  1. Number of participants who achieved HBV DNA levels below limit of detection

    Time frame: Weeks 48 and 72

  2. Number of participants with HBsAg loss

    Time frame: Weeks 48 and 72

  3. Number of participants with both Hepatitis B Surface Antigen (HBsAg) loss and presence of Anti-HBs

    Time frame: Weeks 48 and 72

  4. Number of participants with alanine aminotransferase (ALT) normalization

    Time frame: Weeks 48 and 72

  5. Number of participants with combined response (HBV DNA <100,000 copies/mL, HBeAg loss, and ALT normalization)

    Time frame: Weeks 48 and 72

  6. Incidence of adverse events

    Time frame: up to 72 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Efficacy and Safety of Peginterferon Alfa-2a (40 KD) (Pegasys®) in Patients With HBeAg-Positive Chronic Hepatitis B

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Nov 13, 2015
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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