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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

January 5, 2012
March 22, 2016
October 2005
June 2008   (final data collection date for primary outcome measure)
  • 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.
  • Percentage of patients with hepatitis B virus DNA <100,000 copies/mL [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with hepatitis B virus HBeAg loss rate [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01519921 on ClinicalTrials.gov Archive Site
  • 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.
  • Percentage of patients with alanine aminotransferase (ALT) normalization [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with hepatitis B virus (HBV) DNA below limit of detection [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with a combined response of HBeAg seroconversion, loss of HBeAg, and alanine aminotransferase normalization [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with HBeAg seroconversion [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with loss of HBsAg [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with loss of HBsAg and presence of anti-HBs [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B.
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
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis B, Chronic
Drug: peginterferon alfa-2a [Pegasys]
Peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once a week for 48 weeks
  • 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.
    Intervention: Drug: peginterferon alfa-2a [Pegasys]
  • 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.
    Intervention: Drug: peginterferon alfa-2a [Pegasys]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01519921
ML18495
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Chair: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP