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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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.
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Secondary ID [1]
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PP22512
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis B, Chronic
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mean Change From Baseline in Viral Quantitative e Antibody
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Assessment method [1]
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An acute virologic response was determined by change from baseline in viral antigen/antibody laboratory data.
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Timepoint [1]
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Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)
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Secondary outcome [1]
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Mean Change From Baseline in HBV-DNA log10
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Assessment method [1]
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An acute virologic response was determined by change from baseline in HBV-DNA log10.
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Timepoint [1]
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Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)
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Secondary outcome [2]
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Early Changes in Viral Sequence Associated With Viral Suppression
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Assessment method [2]
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Viral sequence data was obtained from the first 10 participants enrolled in Study but on analysis of the data, numerous low frequency deviations from the HBV consensus sequences were observed in the 454 SLX sequence data which were not replicated in data obtained from routine Sanger sequencing. These sequence deviations did not correspond to a temporal pattern consistent with selection of mutations following HBV treatment. Moreover, they could not be reliably distinguished from sequencing artifacts. It was also revealed that complete genome coverage was not obtained due to errors in the design of the primer sequences. For these reasons, further sequence analyses were not performed for the remaining treatment population.
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Timepoint [2]
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Day 1, 5, 14, Week 4 and 6
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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
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Males
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2012
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Sample size
Target
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Accrual to date
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Final
30
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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New Zealand
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State/province [2]
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Grafton
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Country [3]
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Singapore
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State/province [3]
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Singapore
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Country [4]
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Taiwan
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State/province [4]
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00962871
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Trial related presentations / publications
Mehrotra A, D'Angelo JA, Romney-Vanterpool A, Chu T, Bertoletti A, Janssen HLA, Gehring AJ. IFN-alpha Suppresses Myeloid Cytokine Production, Impairing IL-12 Production and the Ability to Support T-Cell Proliferation. J Infect Dis. 2020 Jun 16;222(1):148-157. doi: 10.1093/infdis/jiaa064. Hong LZ, Hong S, Wong HT, Aw PP, Cheng Y, Wilm A, de Sessions PF, Lim SG, Nagarajan N, Hibberd ML, Quake SR, Burkholder WF. BAsE-Seq: a method for obtaining long viral haplotypes from short sequence reads. Genome Biol. 2014;15(11):517. doi: 10.1186/PREACCEPT-6768001251451949.
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Hoffmann-La Roche
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00962871
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