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A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00962871
First received: August 19, 2009
Last updated: January 14, 2016
Last verified: January 2016

August 19, 2009
January 14, 2016
August 2009
February 2012   (final data collection date for primary outcome measure)
Mean Change From Baseline in Viral Quantitative e Antibody [ Time Frame: Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys) ] [ Designated as safety issue: No ]
An acute virologic response was determined by change from baseline in viral antigen/antibody laboratory data.
Acute immunologic response [ Time Frame: assessed days 1-14 and weekly during follow-up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00962871 on ClinicalTrials.gov Archive Site
  • Mean Change From Baseline in HBV-DNA log10 [ Time Frame: Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys) ] [ Designated as safety issue: No ]
    An acute virologic response was determined by change from baseline in HBV-DNA log10.
  • Early Changes in Viral Sequence Associated With Viral Suppression [ Time Frame: Day 1, 5, 14, Week 4 and 6 ] [ Designated as safety issue: No ]
    Viral sequence data was obtained from the first 10 participants enrolled in Study but on analysis of the data, numerous low frequency deviations from the HBV consensus sequences were observed in the 454 SLX sequence data which were not replicated in data obtained from routine Sanger sequencing. These sequence deviations did not correspond to a temporal pattern consistent with selection of mutations following HBV treatment. Moreover, they could not be reliably distinguished from sequencing artifacts. It was also revealed that complete genome coverage was not obtained due to errors in the design of the primer sequences. For these reasons, further sequence analyses were not performed for the remaining treatment population.
  • Early kinetics of viral suppression [ Time Frame: assessed days 1-14 and weekly during follow-up ] [ Designated as safety issue: No ]
  • Early changes in viral sequence associated with viral suppression [ Time Frame: assessed days 1, 14, 28 and 42 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both
An Open-label, Randomized Study to Evaluate the Acute Immunologic Responses in Asian Subjects With E Antigen Positive Chronic Hepatitis B Following Initiation of Therapy for Hepatitis B With Pegasys, Nucleoside Analogues, or Both.
This open-label, randomized, parallel-arm study will assess the early immunologic response in treatment-naïve Asian male patients with chronic hepatitis B after initiation of treatment with Pegasys or tenofovir or Pegasys plus tenofovir. Patients will be randomized to one of 4 cohorts to receive either Pegasys (360mcg subcutaneously weekly) or tenofovir (300mg orally daily) or both or no treatment for 2 weeks. After 2 weeks on study treatment, patients may opt to receive standard of care treatment with Pegasys. Target sample size is <50.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis B, Chronic
  • Drug: peginterferon alfa-2a [Pegasys]
    360 micrograms sc/week for 2 weeks
  • Drug: tenofovir
    300mg po daily for 2 weeks
  • Active Comparator: 1
    Intervention: Drug: tenofovir
  • Experimental: 2
    Interventions:
    • Drug: peginterferon alfa-2a [Pegasys]
    • Drug: tenofovir
  • Experimental: 3
    Intervention: Drug: peginterferon alfa-2a [Pegasys]
  • No Intervention: 4
Hong LZ, Hong S, Wong HT, Aw PP, Cheng Y, Wilm A, de Sessions PF, Lim SG, Nagarajan N, Hibberd ML, Quake SR, Burkholder WF. BAsE-Seq: a method for obtaining long viral haplotypes from short sequence reads. Genome Biol. 2014;15(11):517.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
February 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • male adults of Southeast and/or East Asian origin, 18-55 years of age
  • HBeAg-positive chronic hepatitis B
  • detectable HBV DNA

Exclusion Criteria:

  • prior antiviral therapy for chronic hepatitis B
  • evidence of bridging fibrosis, cirrhosis or decompensated liver disease
  • positive test at screening for HAV (IgM), HCV, HDV or HIV
  • history or evidence of medical condition associated with chronic liver disease
  • antineoplastic or immunomodulatory treatment </=6 months prior to first dose of study drug
Male
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States,   New Zealand,   Singapore,   Taiwan
 
NCT00962871
PP22512
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
January 2016

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