A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both
NCT ID: NCT00962871
Last Updated: 2016-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2009-08-31
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
tenofovir
300mg po daily for 2 weeks
2
peginterferon alfa-2a [Pegasys]
360 micrograms sc/week for 2 weeks
tenofovir
300mg po daily for 2 weeks
3
peginterferon alfa-2a [Pegasys]
360 micrograms sc/week for 2 weeks
4
No interventions assigned to this group
Interventions
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peginterferon alfa-2a [Pegasys]
360 micrograms sc/week for 2 weeks
tenofovir
300mg po daily for 2 weeks
Eligibility Criteria
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Inclusion Criteria
* HBeAg-positive chronic hepatitis B
* detectable HBV DNA
Exclusion Criteria
* 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
18 Years
55 Years
MALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Los Angeles, California, United States
San Francisco, California, United States
Grafton, , New Zealand
Singapore, , Singapore
Singapore, , Singapore
Taipei, , Taiwan
Countries
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References
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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.
Related Links
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This report describes the early effects of IFNα treatment on immune and viral biomarkers in HBeAg+ CHB patients. The results show that PegIFNα-induced innate immune activation directly benefits from the suppression of HBV replication.
Other Identifiers
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PP22512
Identifier Type: -
Identifier Source: org_study_id
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