A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies
1 other identifier
interventional
29
4 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2009
Typical duration for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2009
CompletedFirst Posted
Study publicly available on registry
August 20, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedApril 8, 2014
April 1, 2014
3.7 years
August 19, 2009
April 7, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
The longitudinal effect on HBV-related markers: viral load, viral antigen/antibody, viral sequence, cellular and humoral immune responses, RNA
assessed every 2 months on treatment (not exceeding maximum approved duration), and up to week 24 of follow-up
Secondary Outcomes (1)
Safety and tolerability: AEs, laboratory parameters, vital signs, concomitant medications
assessed every 2 months on treatment and up to week 24 of follow-up
Study Arms (1)
Single Arm
EXPERIMENTALInterventions
dosage at discretion of investigator based on standard of care (180mcg sc weekly) for up to 48 weeks
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
Los Angeles, California, 90036, United States
Unknown Facility
San Francisco, California, 94143-0538, United States
Unknown Facility
Grafton, 1010, New Zealand
Unknown Facility
Singapore, 119228, Singapore
Unknown Facility
Singapore, 169608, Singapore
Unknown Facility
Taipei, 100, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2009
First Posted
August 20, 2009
Study Start
September 1, 2009
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
April 8, 2014
Record last verified: 2014-04