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A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir 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:
NCT00940485
First received: June 16, 2009
Last updated: November 3, 2014
Last verified: November 2014

June 16, 2009
November 3, 2014
April 2009
December 2011   (final data collection date for primary outcome measure)
HBeAg seroconversion [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00940485 on ClinicalTrials.gov Archive Site
  • Loss of HBeAg; proportion of patients who achieve HBV DNA <1000 copies/mL;ALT normalization; quantitative HBeAg and HBsAg measurement;HBsAg loss/seroconversion [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Adverse events, laboratory parameters, vital signs [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B
A Study on Optimizing HBeAg Seroconversion in HBeAg Positive CHB Patients With Combination or Sequential Treatment of Pegylated Interferon Alpha-2a and Entecavir

This 2 arm study will assess the efficacy and safety of Pegasys in combination o r sequential treatment with entecavir in patients with HBeAg positive chronic he patitis B. Patients who have been pretreated with, and responded to, entecavir f or 9 to 36 months were randomized to one of 2 groups, to receive Pegasys 180micr ograms/week sc for 48 weeks + entecavir 0.5mg po daily for 8 weeks, or entecavir 0.5mg po daily for 48 weeks. The anticipated time on study treatment is 3-12 mo nths.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis B, Chronic
  • Drug: entecavir
    0.5mg po daily for 8 weeks
  • Drug: entecavir
    0.5mg po daily for 48 weeks
  • Drug: peginterferon alfa-2a [Pegasys]
    180 micrograms sc/week for 48 weeks
  • Experimental: 1
    Interventions:
    • Drug: entecavir
    • Drug: peginterferon alfa-2a [Pegasys]
  • Active Comparator: 2
    Intervention: Drug: entecavir
Ning Q, Han M, Sun Y, Jiang J, Tan D, Hou J, Tang H, Sheng J, Zhao M. Switching from entecavir to PegIFN alfa-2a in patients with HBeAg-positive chronic hepatitis B: a randomised open-label trial (OSST trial). J Hepatol. 2014 Oct;61(4):777-84. doi: 10.1016/j.jhep.2014.05.044. Epub 2014 Jun 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >=18 and </= 65 years of age
  • HBeAg positive chronic hepatitis B
  • Pre-treatment with entecavir for 9-36 months

Exclusion Criteria:

  • Antiviral, antineoplastic or immunomodulatory treatment
  • Co-infection with active hepatitis A, C or D, or HIV
  • Evidence of decompensated liver disease
  • History or other evidence of 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
China
 
NCT00940485
ML22265
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

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