HIDIT II - PegIFN-alfa2a Plus Tenofovir in Chronic Delta Hepatitis
NCT ID: NCT00932971
Last Updated: 2018-01-29
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
PHASE2
70 participants
INTERVENTIONAL
2009-06-30
2017-08-02
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
QUADRUPLE
Study Groups
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PEG-IFN alfa-2a plus placebo
Pegylated interferon alfa-2a 180 µg once weekly (QW) subcutaneous (sc) plus placebo once daily, orally
PEG-IFN alfa-2a, placebo
Pegylated interferon alfa-2a, 180µg once weekly, subcutaneously; Placebo, once daily, orally
PEG-IFN alfa-2a plus Tenofovir
Pegylated interferon alfa-2a 180 µg once weekly (QW) subcutaneous (sc) plus Tenofovir disoproxilfumarat 245mg once daily, orally
PEG-IFN alfa-2a, Tenofovir
Pegylated interferon alfa-2a, 180µg once weekly, subcutaneously; Tenofovir disoproxilfumarat, 245mg, once daily, orally
Interventions
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PEG-IFN alfa-2a, Tenofovir
Pegylated interferon alfa-2a, 180µg once weekly, subcutaneously; Tenofovir disoproxilfumarat, 245mg, once daily, orally
PEG-IFN alfa-2a, placebo
Pegylated interferon alfa-2a, 180µg once weekly, subcutaneously; Placebo, once daily, orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years.
* Positive HBsAg, for at least the prior 6 months, positive anti-HDV for at least 3 months and positive for HDV-RNA by PCR within the screening period.
* Elevated serum ALT ≥ ULN but ≤ 10X ULN as determined by two abnormal values taken \> 1 month apart during the 12 months before the first dose of study drug with at least one of the determinations obtained ≤ 35 days prior to the first dose.
* A liver biopsy obtained within the past 12 months demonstrating liver disease consistent with chronic hepatitis. Patients with cirrhosis on liver biopsy must also have a liver imaging investigation to rule out hepatic carcinoma.
* Negative urine or serum pregnancy test documented within the 24 hour period prior to the first dose of test drug.
* Additionally, all fertile males with partners of childbearing age and females should use two reliable forms of effective contraception (combined) throughout the entire period of the study (treatment and for 4 months after treatment completion)
* Creatinine clearance ≥ 70 mL/min
Exclusion Criteria
* Positive test at screening for HAV-Ag-IgM, HCV-RNA or HCV-Ag or HIV-Ag.
* Serum concentrations of ceruloplasmin or alpha-1-antitrypsin consistent with an increased risk of metabolic liver disease.
* Evidence of decompensated liver disease (Childs B-C).
* History or other evidence of a medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures, thalassemia).
* Women with ongoing pregnancy or who are breast feeding.
* WBC count of \< 3.000 cells/ mm3; neutrophil count \< 1.500 cells/mm3or platelet count \< 90.000 cells/mm3.
* Evidence of alcohol and/or drug abuse within one year of entry.
* Patients are excluded if any history of psychiatric disease, especially depression, or of suicidal attempts is evident.
* History of immunologically mediated disease.
* History or other evidence of decompensated liver disease.
* History or other evidence of chronic pulmonary disease associated with functional limitation.
* History of severe cardiac disease
* Evidence of an active or suspected cancer or a history of malignancy where there is a risk of cancer to recur.
* History of having received any systemic anti-neoplastic (including radiation) or immunomodulatory treatment (including systemic corticosteroids) ≤ 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
* History of any organ transplantation with an existing functional graft
* History of thyroid disease poorly controlled on prescribed medications. Patients with elevated thyroid stimulating hormone concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease are excluded.
* History or evidence of severe retinopathy or clinically relevant ophthalmological disorder.
* Inability or unwillingness to provide informed consent or abide by the requirements of the study.
* History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.
* Patients with a value of alpha-fetoprotein \>100 ng/mL are excluded, unless stability (less than 10% increase) has been documented over at least the previous 3 months.
* History or evidence for any intolerance or hypersensitivity to pegylated interferon-alfa-2a, tenofovir or other substances part of the study medication.
* Current participation in any other investigational trial and participation in another investigational trial within 3 months before the trial begins.
18 Years
ALL
No
Sponsors
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Hannover Medical School
OTHER
Hoffmann-La Roche
INDUSTRY
Gilead Sciences
INDUSTRY
HepNet Study House, German Liverfoundation
NETWORK
Responsible Party
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Principal Investigators
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Michael P. Manns, Prof. Dr.
Role: STUDY_DIRECTOR
Hannover Medical School
Locations
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Charité Campus Virchow-Klinikum, Med. Klinik für Gastroenterologie und Hepatologie
Berlin, , Germany
Friedrich-Wilhelms-Universität, Med. Klinik und Poliklinik I
Bonn, , Germany
Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie
Düsseldorf, , Germany
Klinikum der J.W. Goethe-Universität
Frankfurt, , Germany
Universitätsklinikum Hamburg-Eppendorf, Klinik für Innere Medizin
Hamburg, , Germany
Medizinische Hochschule Hannover, Zentrum Innere Medizin
Hanover, , Germany
Medizinische Fakultät der Universität Heidelberg, Innere Medizin IV
Heidelberg, , Germany
Athens University School of Medicine, Hippokration General Hospital
Athens, , Greece
Institutul de Boli Infectioase "Prof. Dr. Matei Bals"
Bucharest, , Romania
Spitalul Clinic de Boli Infectioase si
Timișoara, , Romania
Countries
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References
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Heidrich B, Deterding K, Tillmann HL, Raupach R, Manns MP, Wedemeyer H. Virological and clinical characteristics of delta hepatitis in Central Europe. J Viral Hepat. 2009 Dec;16(12):883-94. doi: 10.1111/j.1365-2893.2009.01144.x. Epub 2009 Jun 28.
Wedemeyer H, Yurdaydin C, Dalekos GN, Erhardt A, Cakaloglu Y, Degertekin H, Gurel S, Zeuzem S, Zachou K, Bozkaya H, Koch A, Bock T, Dienes HP, Manns MP; HIDIT Study Group. Peginterferon plus adefovir versus either drug alone for hepatitis delta. N Engl J Med. 2011 Jan 27;364(4):322-31. doi: 10.1056/NEJMoa0912696.
Heidrich B, Yurdaydin C, Kabacam G, Ratsch BA, Zachou K, Bremer B, Dalekos GN, Erhardt A, Tabak F, Yalcin K, Gurel S, Zeuzem S, Cornberg M, Bock CT, Manns MP, Wedemeyer H; HIDIT-1 Study Group. Late HDV RNA relapse after peginterferon alpha-based therapy of chronic hepatitis delta. Hepatology. 2014 Jul;60(1):87-97. doi: 10.1002/hep.27102.
Hardtke S, Yurdaydin C, Caruntu FA, Curescu MG, Yalcin K, Akarca US, Gurel S, Zeuzem S, Erhardt A, Luth S, Papatheodoridis GV, Port K, Manns MP, Cornberg M, Kahlhofer J, Wedemeyer H. Frequency, Severity and Impact of Pegylated Interferon Alpha-Associated Flares in Hepatitis D Infection. J Viral Hepat. 2025 Apr;32(4):e70022. doi: 10.1111/jvh.70022.
Anastasiou OE, 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, Heidrich B, Mederacke I, von der Leyen H, Kahlhofer J, von Karpowitz M, Hardtke S, Cornberg M, Yurdaydin C, Wedemeyer H. Five-year follow-up of 96 weeks peginterferon plus tenofovir disoproxil fumarate in hepatitis D. Liver Int. 2024 Jan;44(1):139-147. doi: 10.1111/liv.15745. Epub 2023 Oct 3.
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.
Bremer B, Anastasiou OE, Ciesek S, Wedemeyer H. Automated nucleic acid isolation methods for HDV viral load quantification can lead to viral load underestimation. Antivir Ther. 2019;24(2):117-123. doi: 10.3851/IMP3281.
Related Links
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Related Info
Related Info
Other Identifiers
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EudraCT-No.: 2008-005560-13
Identifier Type: -
Identifier Source: secondary_id
Hep-Net-HIDIT-II
Identifier Type: -
Identifier Source: org_study_id
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