Four weeks treatment for chronic hepatitis C in patients under 50 years of age with no significant liver fibrosis

Phase 1

• Conditions: Chronic Hepatitis C; MedDRA version: 20.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2017-005179-21-DK
• Lead Sponsor: Department of infectious Diseases, Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-12
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 227

Inclusion Criteria

•Chronic hepatitis C defined as two positive HCV tests >6 month apart. First test can be anti-HCV, second test must be HCV-RNA
•Age 18-49
•Liver biopsy with F0 or F1 (Metavir score) with in a year of screening. If no liverbiopsy available, a Fibroscan <8 kPa at screening
•All HCV genotypes accepted
•Compliant as judged by study team
•Naïve to all hepatitis C treatment
•Negative pregnancy test for fertile women.
•Negative test for anti-HIV and HbsAg
•IV drug use within the last year including heroin assisted treatment or substitution treatment for opioid dependence

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 227
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Risk of noncompliance
•Clinical signs of cirrhosis (liver biopsy not required), or cirrhosis suspected by blood tests. (INR >1,3 or platelets <130*109/L)
•Contraindication to treatment with study drugs
oPregnancy
oBreastfeeding
oRefusal to use contraceptives
oAllergy to study drug or components.
•Hemoglobin <7.0 mmol/l
•Severe cardiac or pulmonary disease where anemia could be a significant problem
•Receiving medication that have important interactions with study drugs
•Significant liver disease
•Renal impairment (eGFR<60ml/min)
•Unable to understand Danish
•Co-infection with Hepatitis B or HIV
•Any other significant clinical illness deemed to interfere with response to treatment.

Study & Design

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