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NCT Number: NCT01519921

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

This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180 micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow up.

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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

Busan, South Korea

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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, 18-65 years of age
  • HBsAg +ve for more than 6 months, HBeAg +ve, AntiHBs -ve
  • Detectable hepatitis B virus (HBV) DNA (>100,000 copies/mL)

Exclusion criteria

  • Coinfection with hepatitis A, hepatitis C or human immunodeficiency virus (HIV)
  • Evidence of decompensated liver disease
  • A medical condition associated with chronic liver disease other than viral hepatitis

Treatment and study plan

peginterferon alfa-2a [Pegasys]

Drug

Peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once a week for 48 weeks

Primary outcomes

  1. Percentage of Participants With Hepatitis B Virus DNA <100,000 Copies/mL At Week 72

    Time frame: Week 72

    Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (EOF) period (24 weeks after the end of treatment) were classified as responders.

  2. Percentage of Participants With Hepatitis B Virus e Antigen Loss At Week 72

    Time frame: Week 72

    Participants with loss of hepatitis B virus e antigen (HBeAg) at the EOF period (24 weeks after the end of treatment) were classified as responders.

Secondary outcomes

  1. Percentage of Participants With ALT Normalization At Week 48 and Week 72

    Time frame: Week 48 and Week 72

    Participants with ALT less than the upper limit of normal (ULN) at end of treatment (EOT) and EOF period were responders.

  2. Percentage of Participants With Hepatitis B Virus DNA Below the Limit of Detection At Week 48 and Week 72

    Time frame: Week 48 and Week 72

    Participants with HBV-DNA below the limit of detection i.e. <174 copies/mL at EOT and EOF period were responders.

  3. Percentage of Participants With a Combined Response At Week 48 and Week 72

    Time frame: Week 48 and Week 72

    A responder with Combined Response was a participant with HBV-DNA<100,000 copies/mL, HBeAg seroconversion (i.e. loss of HBeAg and presence of anti-HBe) and ALT normalization at EOT and EOF period.

  4. Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion

    Time frame: Week 48 and Week 72

    A responder was a participant with loss of HBeAg and presence of anti-HBe at EOT and EOF period.

  5. Percentage of Participants With Loss of Hepatitis B Surface Antigen At Week 48 and Week 72

    Time frame: Week 48 and Week 72

    A responder was a participant who were analysed with loss of Hepatitis B Surface Antigen (HBsAg) at EOT and EOF period.

  6. Percentage of Participants With Hepatitis B Surface Antigen Seroconversion At Week 48 and Week 72

    Time frame: Week 48 and Week 72

    A responder was a participant with loss of HBsAg and presence of anti-HBs at EOT and EOF period.

  7. Number of Participants With Any Adverse Events and Any Serious Adverse Events

    Time frame: Up to Week 72

    An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Participants with any AEs and any SAEs have been presented.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open Label Phase IV Multicenter Study for Efficacy and Safety of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Patients With HBeAg Positive Chronic Hepatitis B

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jan 27, 2012
Registry last updated
Apr 21, 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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