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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01519921
First received: January 5, 2012
Last updated: March 22, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Hepatitis B, Chronic
Drug: peginterferon alfa-2a [Pegasys]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Hepatitis B Virus DNA <100,000 Copies/mL At Week 72 [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Hepatitis B Virus e Antigen Loss At Week 72 [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Percentage of Participants With ALT Normalization At Week 48 and Week 72 [ Time Frame: Week 48 and Week 72 ] [ Designated as safety issue: No ]
    Participants with ALT less than the upper limit of normal (ULN) at end of treatment (EOT) and EOF period were responders.

  • 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 ] [ Designated as safety issue: No ]
    Participants with HBV-DNA below the limit of detection i.e. <174 copies/mL at EOT and EOF period were responders.

  • Percentage of Participants With a Combined Response At Week 48 and Week 72 [ Time Frame: Week 48 and Week 72 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion [ Time Frame: Week 48 and Week 72 ] [ Designated as safety issue: No ]
    A responder was a participant with loss of HBeAg and presence of anti-HBe at EOT and EOF period.

  • Percentage of Participants With Loss of Hepatitis B Surface Antigen At Week 48 and Week 72 [ Time Frame: Week 48 and Week 72 ] [ Designated as safety issue: No ]
    A responder was a participant who were analysed with loss of Hepatitis B Surface Antigen (HBsAg) at EOT and EOF period.

  • Percentage of Participants With Hepatitis B Surface Antigen Seroconversion At Week 48 and Week 72 [ Time Frame: Week 48 and Week 72 ] [ Designated as safety issue: No ]
    A responder was a participant with loss of HBsAg and presence of anti-HBs at EOT and EOF period.

  • Number of Participants With Any Adverse Events and Any Serious Adverse Events [ Time Frame: Up to Week 72 ] [ Designated as safety issue: No ]
    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.


Enrollment: 150
Study Start Date: October 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEG-IFN alfa-2a (Treatment naïve)
Eligible treatment naïve participants received peginterferon alfa-2a (PEGASYS) 180 micrograms (mcg) subcutaneously (SC) once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
Drug: peginterferon alfa-2a [Pegasys]
Peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once a week for 48 weeks
Experimental: PEG-IFN alfa-2a (YMDD mutant)
Eligible tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
Drug: peginterferon alfa-2a [Pegasys]
Peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once a week for 48 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519921

Locations
Korea, Republic of
Busan, Korea, Republic of, 49241
Daegu, Korea, Republic of, 41944
Seoul, Korea, Republic of, 03722
Seoul, Korea, Republic of, 05505
Seoul, Korea, Republic of, 06351
Seoul, Korea, Republic of, 08308
Seoul, Korea, Republic of, 14647
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01519921     History of Changes
Other Study ID Numbers: ML18495 
Study First Received: January 5, 2012
Results First Received: December 17, 2015
Last Updated: March 22, 2016
Health Authority: Korea: Korea Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Peginterferon alfa-2a
Anti-Infective Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on May 05, 2016