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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00962975




Registration number
NCT00962975
Ethics application status
Date submitted
19/08/2009
Date registered
20/08/2009
Date last updated
8/04/2014

Titles & IDs
Public title
A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies
Scientific title
Secondary ID [1] 0 0
PP22612
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - peginterferon alfa-2a [Pegasys]

Experimental: Single Arm -


Treatment: Drugs: peginterferon alfa-2a [Pegasys]
dosage at discretion of investigator based on standard of care (180mcg sc weekly) for up to 48 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The longitudinal effect on HBV-related markers: viral load, viral antigen/antibody, viral sequence, cellular and humoral immune responses, RNA
Timepoint [1] 0 0
assessed every 2 months on treatment (not exceeding maximum approved duration), and up to week 24 of follow-up
Secondary outcome [1] 0 0
Safety and tolerability: AEs, laboratory parameters, vital signs, concomitant medications
Timepoint [1] 0 0
assessed every 2 months on treatment and up to week 24 of follow-up

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- hepatic decompensation (Child-Pugh class B and C)

- antiviral, antineoplastic or immunomodulatory treatment

- evidence of alcohol and/or drug abuse

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2013
Sample size
Target
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
New Zealand
State/province [2] 0 0
Grafton
Country [3] 0 0
Singapore
State/province [3] 0 0
Singapore
Country [4] 0 0
Taiwan
State/province [4] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00962975
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00962975