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Completed

NCT Number: NCT02570191

A Study of PEGASYS (Peginterferon Alfa-2a [40KD]) in Patients With Hepatitis B e Antigen (HBeAg)-Negative Chronic Hepatitis B Virus (HBV)

This study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the target sample size is 60 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–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pleven, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult participants 18-70 years of age
  • Positive test result for HBsAg for >6 months
  • Naive to treatment for HBV
  • On liver biopsy, liver disease consistent with chronic HBV, with or without compensated cirrhosis

Exclusion criteria

  • Co-infection with hepatitis A, C or D, or with Human Immunodeficiency Virus (HIV)
  • Decompensated liver disease
  • Hepatocellular cancer
  • Systemic anti-viral, anti-neoplastic, or immunomodulatory therapy less than or equal to 6 months before study drug
  • Medical condition associated with chronic liver disease

Treatment and study plan

Peginterferon alfa-2a

Drug

180 uG in 0.5 mL solution administered once weekly for 48 weeks

Other names: Pegasys

Primary outcomes

  1. Efficacy: Hepatitis B Virus - Deoxy ribonucleic acid (HBV-DNA) less than (<)20,000 Copies per milliliter (copies/mL) At End of Follow-Up

    Time frame: 72 Weeks

  2. Alanine Transaminase (ALT) Normalization at the End of Follow-Up

    Time frame: 72 Weeks

Secondary outcomes

  1. Efficacy: Loss of Hepatitis B Virus Antigen ( HBsAg) and Seroconversion at End of Follow-Up

    Time frame: 72 Weeks

  2. Hepatitis B Virus (HBV) DNA Below the Limit of Quantification At the End of Follow-Up

    Time frame: 72 Weeks

  3. HBV DNA Suppression <20000 Copies/mL at the End of Treatment

    Time frame: 48 Weeks

  4. Alanine Transaminase (ALT) Normalization at the End of Treatment

    Time frame: 48 Weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-label, Multicenter, National, Not-randomized Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (40 KD) (PEGASYS) in Patients With HBeAg-negative Chronic Hepatitis B

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Oct 7, 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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