Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00962975
First received: August 19, 2009
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

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
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 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
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
Auckland, New Zealand, 1150
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: May 7, 2013
Health Authority: New Zealand: Health Research Council

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

ClinicalTrials.gov processed this record on May 16, 2013