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HIDIT II - PegIFN-alfa2a Plus Tenofovir in Chronic Delta Hepatitis

Information source: HepNet Study House, German Liverfoundation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis D

Intervention: PEG-IFN alfa-2a, Tenofovir (Drug); PEG-IFN alfa-2a, placebo (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: HepNet Study House, German Liverfoundation

Official(s) and/or principal investigator(s):
Michael P. Manns, Prof. Dr., Study Director, Affiliation: Hannover Medical School


Randomized, double blind study comparing the efficacy of pegylated interferon-alfa2a plus placebo versus pegylated interferon-alfa2a plus tenofovir for the treatment of chronic delta hepatitis. 70 Patients will be randomized 1: 1 into the two groups. Treatment duration: 96 weeks. Follow-up: 24 weeks. Long-term-follow-up: until week 358.

Clinical Details

Official title: A Multicenter Randomised Study Comparing the Efficacy of PegIFN-alfa2a Plus Placebo vs. PegIFN-alfa2a Plus Tenofovir for the Treatment of Chronic Delta Hepatitis-The Hep-Net International Delta Hepatitis Interventional Trial II (HIDIT-II)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Negativation of HDV-RNA at the end of therapy

Secondary outcome:

Negativation of HDV-RNA at week 48 of treatment

Negativation of HDV-RNA 24 weeks after the end of treatment

Normalization of ALT levels at the end of treatment and at the end of follow-up

HDV-RNA-levels over time

Suppression of HBV-DNA below 6 IU/ml using the Cobas TaqMan assay at treatment weeks 48 and 96 and 24 weeks after treatment

Liver histology at end of treatment (Ishak score for inflammation and fibrosis)

Quantitative HBsAg levels over time. Loss of HBsAg and development of anti-HBs antibodies, intrahepatic cccDNA and HBV-DNA levels over time

HBV- and HDV-virus-specific T cell responses during therapy and after 24 weeks of follow up if virological and biochemical efficacy has been shown

Virological long-term outcome

Clinical long-term outcome

Quality of Life


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Written informed consent.

- 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:

- Patients must not have received antiviral therapy for their chronic hepatitis D

within the previous 6 months. Patients who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded.

- 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


- 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


- 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.

Locations and Contacts

Charité Campus Virchow-Klinikum, Med. Klinik für Gastroenterologie und Hepatologie, Berlin 13353, Germany

Friedrich-Wilhelms-Universität, Med. Klinik und Poliklinik I, Bonn 53105, Germany

Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Düsseldorf 40225, Germany

Klinikum der J.W. Goethe-Universität, Frankfurt 60590, Germany

Universitätsklinikum Hamburg-Eppendorf, Klinik für Innere Medizin, Hamburg 20246, Germany

Medizinische Hochschule Hannover, Zentrum Innere Medizin, Hannover 30625, Germany

Medizinische Fakultät der Universität Heidelberg, Innere Medizin IV, Heidelberg 69120, Germany

Universitätsklinikum Leipzig, Leipzig 04103, Germany

Klinikum Großhadern, Med. Klinik 2, München 81366, Germany

Med. Poliklinik der Universität Würzburg, Würzburg 97080, Germany

Athens University School of Medicine, Hippokration General Hospital, Athens 11527, Greece

Institutul de Boli Infectioase "Prof. Dr. Matei Bals", Bucharest 021105, Romania

Spitalul Clinic de Boli Infectioase si, Timisoara 300312, Romania

Additional Information

Related publications:

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, Yurdaydìn C, Dalekos GN, Erhardt A, Çakaloğlu Y, Değertekin H, Gürel 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.

Starting date: June 2009
Last updated: December 3, 2014

Page last updated: August 23, 2015

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