Investigating risk factors and transmission of acute Hepatitis C: The UK Acute Hepatitis C cohort

Not Applicable

• Conditions: Hepatitis C; Infections and Infestations

• Registration Number: ISRCTN10510711
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-05
• Last Update Posted: 14 June 2021
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Adults (aged >=18 years) with acute hepatitis C (HCV) infection
2. Evidence of acute hepatits C infection or re-infection defined:
I. A positive HCV RNA test in the presence of a negative anti-HCV test (antibody and/or antigen and/or HCV RNA) within the past 12 months
II. A positive HCV RNA test with an acute clincial hepatitis (jaundice or ALT rise >5x ULN) and no other identifiable cause;
III. A positive HCV RNA test in patients who had previously achieved spontaneous clearance (anti-HCV positive individuals with two consecutive negative HCV RNA results 24 weeks apart and did not receive treatment), sustained virological response following treatment (negative HCV RNA result 24 (for IFN-based) or 12 weeks (DAA), after stopping treatment or later
IV. Evidence of HCV genotype and/or sub-type switch

Exclusion Criteria

Evidence of HCV infection not consistent with the case definition for acute hepatitis C

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Descriptive statistics (n[%]) of participant characteristics (demographics and risk factors) measured using a bespoke questionnaire and review of medical notes and virus characteristics (genotype) at baseline and during follow up as measured by routine Sanger sequencing and Whole Genome Sequencing