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

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.

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Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Grafton, New Zealand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

peginterferon alfa-2a [Pegasys]

Drug

dosage at discretion of investigator based on standard of care (180mcg sc weekly) for up to 48 weeks

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: Aug 20, 2009
Registry last updated: Apr 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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