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
  Purpose

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.


Condition Intervention Phase
Hepatitis B, Chronic
Drug: peginterferon alfa-2a [Pegasys]
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 29
Study Start Date: September 2009
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: peginterferon alfa-2a [Pegasys]
dosage at discretion of investigator based on standard of care (180mcg sc weekly) for up to 48 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962975

Locations
United States, California
Los Angeles, California, United States, 90036
San Francisco, California, United States, 94143-0538
New Zealand
Grafton, New Zealand, 1010
Singapore
Singapore, Singapore, 169608
Singapore, Singapore, 119228
Taiwan
Taipei, Taiwan, 100
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00962975     History of Changes
Other Study ID Numbers: PP22612
Study First Received: August 19, 2009
Last Updated: April 7, 2014
Health Authority: New Zealand: Health Research Council

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Peginterferon alfa-2a
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014