Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00962975
First received: August 19, 2009
Last updated: April 7, 2014
Last verified: April 2014

August 19, 2009
April 7, 2014
September 2009
May 2013   (final data collection date for primary outcome measure)
The longitudinal effect on HBV-related markers: viral load, viral antigen/antibody, viral sequence, cellular and humoral immune responses, RNA [ Time Frame: assessed every 2 months on treatment (not exceeding maximum approved duration), and up to week 24 of follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00962975 on ClinicalTrials.gov Archive Site
Safety and tolerability: AEs, laboratory parameters, vital signs, concomitant medications [ Time Frame: assessed every 2 months on treatment and up to week 24 of follow-up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies
Not Provided

In this open-label multicenter study the long-term effect of Pegasys monotherapy on pharmacodynamic HBV-related markers will be investigated in patients with chronic hepatitis B. Eligible patients will have completed treatment on another donor protocol (e.g. PP22512) and will receive Pegasys at an appropriate dose based on the standard of care (180mcg sc once weekly) for up to 48 weeks. Target sample size is <100.

Not Provided
Interventional
Phase 1
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]
dosage at discretion of investigator based on standard of care (180mcg sc weekly) for up to 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
29
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients >/=18 years of age
  • previous participation in other donor protocol
  • chronic hepatitis B
  • no other anti-HBV treatment after completion of previous donor protocol
  • female patients and female partners of male patients must use at least two methods of contraception until 28 days after completion of study

Exclusion Criteria:

  • hepatic decompensation (Child-Pugh class B and C)
  • antiviral, antineoplastic or immunomodulatory treatment
  • evidence of alcohol and/or drug abuse
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   New Zealand,   Singapore,   Taiwan
 
NCT00962975
PP22612
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

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