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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00962975

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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Peginterferon Alfa-2a

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:	24
Study Start Date:	September 2009
Estimated Study Completion Date:	September 2013

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

Grafton, 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:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00962975 History of Changes
Other Study ID Numbers:	PP22612
Study First Received:	August 19, 2009
Last Updated:	May 21, 2012
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 23, 2012