A clinical trial to investigate the safety and efficacy of terbinafine for chronic infection of the liver with the hepatitis B virus.

Phase 1

• Conditions: Chronic hepatitis B infection; MedDRA version: 20.0Level: LLTClassification code 10052552Term: Hepatitis B virusSystem Organ Class: 100000004848; MedDRA version: 20.1Level: LLTClassification code 10047450Term: Viral hepatitis BSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: LLTClassification code 10019743Term: Hepatitis B virus (HBV)System Organ Class: 100000004848; MedDRA version: 20.0Level: LLTClassification code 10019737Term: Hepatitis B carrierSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2019-003419-68-NL
• Lead Sponsor: Academic Medical Center (AMC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-24
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1) Age 18 – 60 years
2) Proven chronic hepatitis B (CHB) for more than 6 months, based on serology (HBsAg positivity) and at screening a viral load of:
i) Group A: HBV DNA =200 IU/mL and <20,000 IU/mL
ii) Group B: HBV DNA < 20 IU/mL
3) HBeAg-positive and –negative CHB patients
4) No current use of any antiviral medication (group A) or currently treated with tenofovir only.
5) Normal liver function, assessed by:
i) Fibroscan of = 7.0 kiloPascal (kPa)
ii) Alanine aminotransferase (ALT) and/or aspirate aminotransferase (AST) at screening = 1.25 x upper limit of normal (ULN)
iii) Thrombocytes 150-400 10E9/L
iv) Total bilirubin 0-17 µmol/L (elevated levels may be accepted if unconjugated portion is elevated in patients with Gilbert syndrome)
v) Albumin within normal value (35 – 50 g/L)
vi) Prothrombin Time (PT) within normal value (9,5 - 12.5 sec)
vii) Alkaline phosphatase (ALP) and Gamma-glutamyltransferase (GGT) within normal values (40-120 U/L and 0-40 U/L respectively)
6) Body mass index (BMI): 17.0-35.0 kg/m2
7) Clinical chemistry, hematologic and coagulation tests at screening must be within normal limits or clinically non-significant, as by the investigators assessment.
8) At screening, women of child bearing potential must be non-pregnant and non-lactating proven by negative urine or serum pregnancy test at screening.
9) Female patients of child-bearing potential (with a fertile male sexual partner) and male patients (if not surgically sterilized) must be willing to use adequate contraception from screening until last study visit.
10) At screening, has no recent (<3 months) history of any clinically significant conditions, which, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results.
11) Voluntary written informed consent must be obtained before any study related interventions (including screening and enrollment) can be conducted.
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 26
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Currently active, or a history of liver cirrhosis determined by one or more of the following:
i) Liver biopsy;
ii) Elastography (e.g. Fibroscan);
iii) Combination of usual radiological and biochemical criteria
2) Currently active, liver disease other than CHB
3) Co-infection with HCV, HDV, HEV and/or HIV
4) Acute HAV at screening
5) Renal impairment (estimated glomerular filtration rate (eGRF) < 60ml/min)
6) Currently active, or a history of: psoriasis or lupus erythematodes
7) Use of oral medication that interacts with the liver metabolism enzyme CYP2D6, or which is known to be hepatotoxic or otherwise known to interact with terbinafine (such as rifampicine).
8) Usage or plans to receive systemic immunosuppressive or immunomodulating medications (e.g. IFN) during the study or = 4 months prior to the first investigational product administration.
9) Clinical diagnosis of substance abuse = 12 months prior to screening with narcotics or cocaine or with alcohol (regular consumption > 14 units/week [men] and > 7 units/week [women])
10) Inability to understand the patient information and make an informed decision to participate

Study & Design

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