A multicenter, single-arm prospective study to determine safety and efficacy of GLE/PIB 8-week treatment in adults and adolescents acutely infected with hepatitis C virus

Phase 1

• Conditions: Hepatitis C Virus; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-005777-27-ES
• Lead Sponsor: AbbVie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-09
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 283

Inclusion Criteria

- Adult or adolescent, age 12 years and older weighing at least 45 kg.
- Subject must have evidence of acute HCV infection prior to enrollment. Evidence of acute HCV infection is defined as physician diagnosis of
acute HCV infection and at least 1 of the following:
- Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 8-month period prior to Screening OR Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 11-month period prior to Screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen OR Clinical signs and symptoms compatible with acute hepatitis (ALT > 5 × ULN and/or jaundice) in the absence of a history of chronic liver disease or other cause of acute hepatitis and positive HCV RNA or HCV core antigen all within an 8-month period prior to Screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen OR Negative anti-HCV antibody with a positive HCV RNA or HCV core antigen within a 5-month period prior to Screening.
- Subject must be HCV treatment-naïve, defined as no prior treatment including interferon for this HCV infection.
- Subject must be documented as either having no cirrhosis or as having compensated cirrhosis.
- Absence of hepatocellular carcinoma (HCC) for subjects with cirrhosis as indicated by a negative ultrasound, computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or a negative ultrasound at Screening. Subject who has a positive ultrasound result suspicious of HCC followed by a subsequent negative CT scan or MRI or biopsy result will be eligible for the study.
- No history of liver decompensation
Are the trial subjects under 18? yes
Number of subjects for this age range: 15
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 253
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

- Evidence of chronic HCV infection for this HCV infection.
- Subject has a history of severe life-threatening or other significant sensitivity to any excipients of the study drug.
- Subject has cause of liver disease other than HCV infection
- Subject has uncontrolled drug use that may impair protocol compliance in the
opinion of the investigator.
- Female who is pregnant or breastfeeding; or is considering becoming pregnant or donating eggs during the study or for approximately 30 days after the last dose of study drug.
- Subject must require chronic use of systemic immunosuppressants during the study

Study & Design

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