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

Completed · Phase 1

Conditions studied: Hepatitis B, Chronic

In brief

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.

Key facts

Study ID

NCT00962975

Run by

Hoffmann-La Roche

People needed

29

Starts

2009-09-01

Expected to finish

2013-05-01

Last updated by the study team

2014-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• hepatic decompensation (Child-Pugh class B and C)
• antiviral, antineoplastic or immunomodulatory treatment
• evidence of alcohol and/or drug abuse

Where it is running

• Study site — Los Angeles, California, United States
• Study site — San Francisco, California, United States
• Study site — Grafton, New Zealand
• Study site — Singapore, Singapore
• Study site — Singapore, Singapore
• Study site — Taipei, Taiwan

Full record on ClinicalTrials.gov

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