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NCT Number: NCT00487747

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

This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c. weekly for 48 weeks, followed by 48 weeks 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–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chelyabinsk, Russia

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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 patients, 18-70 years of age;
  • chronic hepatitis B;
  • Hepatitis B Virus (HBV) DNA >100,000 copies/mL.

Exclusion criteria

  • previous antiviral or interferon-based therapy for chronic hepatitis B in past 6 months;
  • evidence of decompensated liver disease;
  • history or evidence of a medical condition associated with chronic liver disease other than viral hepatitis;
  • coinfection with hepatitis A, C or D, or HIV.

Treatment and study plan

peginterferon alfa-2a [Pegasys]

Drug

180 micrograms sc weekly for 48 weeks

Primary outcomes

  1. Number of HBeAg Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid <100,000 Copies Per mL

    Time frame: Week 96

    This study included four Hepatitis B Early Antigen (HBeAg) positive participants. Participants with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <100,000 copies/mL were reported.

  2. Number of HBeAg Negative Participants With HBV DNA < 20,000 Copies Per mL

    Time frame: Week 96

    This study included 14 HBeAg negative participants. Participants with HBV DNA <20,000 copies/mL were reported.

Secondary outcomes

  1. Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion

    Time frame: Week 96

    Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of Hepatitis B surface antibody (HBsAb). Sustained HBe seroconversion is defined as loss of HBeAg and presence of hepatitis B e-antibody (HBeAb). This study included 4 HBeAg positive participants.

  2. Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT

    Time frame: Week 96

    Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of HBsAb. This study included 14 HBeAg negative participants.

  3. Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)

    Time frame: Up to Week 96

    All participants who received at least one dose of the study drug were analysed. Number of participants with any adverse events and any serious adverse events are reported.

  4. Mean Change in Laboratory Parameters (ALT Levels)

    Time frame: From Screening (Day 0) to Week 96

    Mean Change in Laboratory parameters (ALT levels) is reported.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

PEGASYS® (Peginterferon Alpha-2a 40KD) in Patients With HBeAg-positive and HBeAg-negative Chronic Hepatitis B

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jun 19, 2007
Registry last updated
Apr 6, 2017

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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