A multicenter randomised study comparing the efficacy of pegylated interferon-alfa-2a plus placebo vs. pegylated interfeorn-alfa-2a plus tenofovir for the treatment of chronic delta hepatitis- The Hep-Net International Delta hepatits Interventional Trial II (HIDIT-II) - HIDIT-II

Phase 1

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10047455Term: Viral hepatitis B without mention of hepatic coma, with hepatitis delta; To compare the virological efficacy (HDV-RNA) and safety of 96 weeks of therapy with pegylated interferon-alfa-2a plus tenovofir to 96 weeks of therapy with pegylated interferon-alfa-2a plus placebo for the treatment with chronic delta hepatits virus.

• Registration Number: EUCTR2008-005560-13-GR
• Lead Sponsor: Medizinische Hochschule Hannover

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-20
• Last Update Posted: 9 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Age >= 18 years;
2. 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.
3. 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.
4. A liver biopsy obtained within the past 12 months demonstrating liver disease consistent with chronic hepatitis. Patients with cirrhosis (e.g. Metavir F4, Ishak fibrosis score = 5-6) on liver biopsy must also have a liver imaging investigation to rule out hepatic carcinoma.
5. Negative urine or serum pregnancy test (for women of childbearing potential) 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 ): these may include, but are not limited to, birth control pills, IUDs, condoms, diaphragms, implants, surgical sterilization, or being in a post-menopausal state
6.Creatinine clearance > = 70 mL/min by the following formula:
((140-age in years) (body weight (kg)):((72) (serum creatinine [mg/dl]))
[Note: multiply estimated rate by 0.85 for women]
7. written informent consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. 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. Exception: patients who have had a limited (<=7 day) course of acyclovir for herpetic lesions more than 1 month prior to the first administration of test drug are not excluded.
2. Positive test at screening for HAV-Ag IgM, HCV-RNA or HCV-Ag or HIV-Ag.
3.Serum concentrations of ceruloplasmin or alfa1-antitrypsin consistent with an increased risk of metabolic liver disease.
4. Evidence of decompensated liver disease (Childs B-C).
5. History or other evidence of a medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures, thalassemia).
6. Women with ongoing pregnancy or who are breast feeding.
7. WBC count of <3.000 cells/ mm3; neutrophil count <1.500 cells/mm3or platelet count <90.000 cells/mm3.
8. Evidence of alcohol and/or drug abuse within one year of entry.
9. Patients are excluded if any history of psychiatric disease, especially depression, or of suicidal attempts is evident.
10. History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis).
11. History or other evidence of decompensated liver disease.
(Coagulopathy, hyperbilirubinemia, hepatic encephalopathy, hypo-albuminemia, ascites, and bleeding from oesophageal varices are conditions consistent with decompensated liver disease)
12. History or other evidence of chronic pulmonary disease associated with functional limitation.
13. History of severe cardiac disease (e.g., NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases).
14. Evidence of an active or suspected cancer or a history of malignancy where there is a risk of cancer to reccur.
15.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.
16. History of any organ transplantation with an existing functional graft
17. 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.
18. History or evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or clinically relevant ophthalmological disorder (e.g. due to diabetes mellitus or hypertension)
19. Inability or unwillingness to provide informed consent or abide by the requirements of the study.
20. 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.
21. 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.
22. Reassessments: If a patient fails to meet the above inclusion /e

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified