A Study of Pegasys (Peginterferon Alfa 2a) Alone or in Combination With Tenofovir in Patients With Chronic Hepatitis D.
NCT ID: NCT01088659
Last Updated: 2019-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
50 participants
INTERVENTIONAL
2010-02-16
2017-12-29
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
DOUBLE
Study Groups
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1
peginterferon alfa-2a [Pegasys]
180mcg sc weekly, 96 weeks
placebo
orally daily, 96 weeks
2
peginterferon alfa-2a [Pegasys]
180mcg sc weekly, 96 weeks
tenofovir
245mg po daily, 96 weeks
Interventions
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peginterferon alfa-2a [Pegasys]
180mcg sc weekly, 96 weeks
placebo
orally daily, 96 weeks
tenofovir
245mg po daily, 96 weeks
Eligibility Criteria
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Inclusion Criteria
* chronic hepatitis D
* positive for HBsAg \>/=6 months, for anti-HDV \>/=3 months and for HDV-RNA at screening
* negative pregnancy test; fertile males and women of childbearing age should use two reliable forms of contraception throughout study
Exclusion Criteria
* previous therapy with pegylated interferon alfa
* treatment with conventional interferon alfa for \>12 months
* hepatitis A or C, or HIV infection
* decompensated liver disease (Childs B-C)
* history or evidence of medical condition associated with chronic liver disease
18 Years
ALL
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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Ankara University Medical Facility; Hepatology Department
Ankara, , Turkey (Türkiye)
Uni of Uludag Faculty of Medicine; I, Hastaliklari Anabilim Dali
Bursa, , Turkey (Türkiye)
Dicle Uni Medical Faculty; Gastroenterology
Diyarbakır, , Turkey (Türkiye)
Istanbul Uni Cerrahpasa Medical Faculty; Gastroenterolgy
Istanbul, , Turkey (Türkiye)
Ege Uni Medical Faculty Izmir; Gastroenterology
Izmir, , Turkey (Türkiye)
Dokuz Eylul University Medical Faculty; Infection
Izmir, , Turkey (Türkiye)
Countries
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References
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Wedemeyer H, Yurdaydin C, Hardtke S, Caruntu FA, Curescu MG, Yalcin K, Akarca US, Gurel S, Zeuzem S, Erhardt A, Luth S, Papatheodoridis GV, Keskin O, Port K, Radu M, Celen MK, Idilman R, Weber K, Stift J, Wittkop U, Heidrich B, Mederacke I, von der Leyen H, Dienes HP, Cornberg M, Koch A, Manns MP; HIDIT-II study team. Peginterferon alfa-2a plus tenofovir disoproxil fumarate for hepatitis D (HIDIT-II): a randomised, placebo controlled, phase 2 trial. Lancet Infect Dis. 2019 Mar;19(3):275-286. doi: 10.1016/S1473-3099(18)30663-7.
Other Identifiers
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ML22364
Identifier Type: -
Identifier Source: org_study_id
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