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: August 26, 2014
Last verified: August 2014

January 5, 2012
August 26, 2014
October 2005
October 2008   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01519921 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Percentage of patients with alanine aminotransferase (ALT) normalization [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
Same as current
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 strati fied into group A (treatment naïve patients) or B (YMDD mutant patients). All p atients will receive PEGASYS 180 micrograms subcutaneously once weekly for 48 we eks, 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: Single Arm
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
October 2008
October 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 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
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01519921
ML18495
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Chair: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

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