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HIDIT II - PegIFN-alfa2a Plus Tenofovir in Chronic Delta Hepatitis | Clinical Trials | Clareo Health

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

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)

NCT00932971•HepNet Study House, German Liverfoundation

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+13 more criteria

Locations (10)

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

Key Dates

Start Date

June 1, 2009

Primary Completion Date

August 1, 2017

Completion Date

August 2, 2017

Last Updated

January 29, 2018

Enrollment

ACTUAL participants

Conditions

Hepatitis D

Interventions

PEG-IFN alfa-2a, Tenofovir

DRUG

PEG-IFN alfa-2a, placebo

DRUG

DELTA DESCRIBE: the French Collaborative Project

NCT05936073

Hepatitis D

View study

RECRUITING

HDV Screening Study

NCT06889805

Hepatitis D Virus Infection

View study

RECRUITING

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

NCT04166266

Hepatitis D, Chronic

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

DELTA DESCRIBE: the French Collaborative Project

HDV Screening Study

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

Standardising Care for Hepatitis Delta in the Netherlands

Finite Treatment of Hepatitis Delta With Bulevirtide: Identification of Biomarkers Associated With Sustained Control of HDV Infection

Study of Bulevirtide in Participants With Chronic Hepatitis D Infection