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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/NCT00962871




Registration number
NCT00962871
Ethics application status
Date submitted
19/08/2009
Date registered
20/08/2009
Date last updated
8/02/2016

Titles & IDs
Public title
A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both
Scientific title
An Open-label, Randomized Study to Evaluate the Acute Immunologic Responses in Asian Subjects With E Antigen Positive Chronic Hepatitis B Following Initiation of Therapy for Hepatitis B With Pegasys, Nucleoside Analogues, or Both.
Secondary ID [1] 0 0
PP22512
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]
Treatment: Drugs - tenofovir

Active Comparator: 1 -

Experimental: 2 -

Experimental: 3 -

No Intervention: 4 -


Treatment: Drugs: peginterferon alfa-2a [Pegasys]
360 micrograms sc/week for 2 weeks

Treatment: Drugs: tenofovir
300mg po daily for 2 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change From Baseline in Viral Quantitative e Antibody
Timepoint [1] 0 0
Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)
Secondary outcome [1] 0 0
Mean Change From Baseline in HBV-DNA log10
Timepoint [1] 0 0
Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)
Secondary outcome [2] 0 0
Early Changes in Viral Sequence Associated With Viral Suppression
Timepoint [2] 0 0
Day 1, 5, 14, Week 4 and 6

Eligibility
Key inclusion criteria
- male adults of Southeast and/or East Asian origin, 18-55 years of age

- HBeAg-positive chronic hepatitis B

- detectable HBV DNA
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- prior antiviral therapy for chronic hepatitis B

- evidence of bridging fibrosis, cirrhosis or decompensated liver disease

- positive test at screening for HAV (IgM), HCV, HDV or HIV

- history or evidence of medical condition associated with chronic liver disease

- antineoplastic or immunomodulatory treatment </=6 months prior to first dose of study
drug

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
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
1/08/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2012
Sample size
Target
Accrual to date
Final
30
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
This open-label, randomized, parallel-arm study will assess the early immunologic response in
treatment-naïve Asian male patients with chronic hepatitis B after initiation of treatment
with Pegasys or tenofovir or Pegasys plus tenofovir. Patients will be randomized to one of 4
cohorts to receive either Pegasys (360mcg subcutaneously weekly) or tenofovir (300mg orally
daily) or both or no treatment for 2 weeks. After 2 weeks on study treatment, patients may
opt to receive standard of care treatment with Pegasys. Target sample size is <50.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00962871
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/NCT00962871