Status:
COMPLETED
A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 wil...
Eligibility Criteria
Inclusion
- 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
- hepatic decompensation (Child-Pugh class B and C)
- antiviral, antineoplastic or immunomodulatory treatment
- evidence of alcohol and/or drug abuse
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00962975
Start Date
September 1 2009
End Date
May 1 2013
Last Update
April 8 2014
Active Locations (6)
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1
Los Angeles, California, United States, 90036
2
San Francisco, California, United States, 94143-0538
3
Grafton, New Zealand, 1010
4
Singapore, Singapore, 119228