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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00962975
Recruitment Status : Completed
First Posted : August 20, 2009
Last Update Posted : April 8, 2014
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: peginterferon alfa-2a [Pegasys] Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2009
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00962975

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

Responsible Party: Hoffmann-La Roche Identifier: NCT00962975     History of Changes
Other Study ID Numbers: PP22612
First Posted: August 20, 2009    Key Record Dates
Last Update Posted: April 8, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis, Chronic
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents