Viral hepatitis Infections and Infestations
Conditions
Interventions
There is no experimental treatment in this study
standard hepatitis c treatment will be provided by the NHS independently of the study. Participants in the study will be asked only to donate blood samples on 3-4 visits and complete health screening
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Willing and able to give informed consent for participation in the study. 2. Aged 18 years or above. 3. Hepatitis C viral load greater than 50,000 IU/ml for participants with chronic hepatitis C; greater than 10,000 IU/ml for participants with acute hepatitis C. 4. Infection with hepatitis C genotypes 1 or 3. 5. Willingness to give blood to be used for the development of an HCV inoculum. 6. Agree to allow study staff to inform and receive information from the participant’s clinical care team, including primary and secondary clinical care team, regarding study participation and HCV treatment outcomes. 7. Agree to allow access to clinical records for the duration of the study. 8. Agree to allow access to study records by a study audit team. 9. Eligible and willing to receive currently approved DAA therapy. 10. In the study investigator’s and clinical care team’s opinions, able and willing to comply with all trial requirements.
Exclusion criteria
Exclusion criteria: 1. Tested positive for HIV. 2. Tested positive for syphilis. 3. Are a hepatitis B carrier (HBcAb and/or HBsAg positive). 4. Are HTLV positive. 5. Cancer diagnosis within the last 12 months or an ongoing cancer diagnosis (except basal cell carcinoma of the skin). 6. Had an organ transplant. 7. Have been diagnosed with variant Creutzfeldt-Jakob Disease (vCJD). 8. Are pregnant or have had a baby in the past 6 months. 9. Have travelled to regions with malaria, dengue, Zika, or other mosquito-borne infections in the last month. 10. Undergoing medical investigation or assessment (e.g., for a heart condition). 11. Haemoglobin levels below at least 130 g/L for men and 115 g/L for women on up to two consecutive visits. 12. History of any serious psychiatric condition in the last 3 years requiring hospital specialist supervision. 13. History of any other serious chronic illness requiring hospital specialist supervision, except active or suspected substance abuse. 14. Populations considered vulnerable under ICH-GCP E6(R3) due to potentially compromised ability to give fully informed and voluntary consent, including: • Individuals who may feel pressured to participate due to professional roles (e.g., medical or research staff involved in the study). • Individuals living in institutional or controlled environments (e.g., prisoners). • Individuals in very unstable social settings (e.g., homeless persons, nomadic populations, certain categories of refugees). 15. Anything else which, in the opinion of the Investigator, may influence the individual’s ability to meaningfully consent to or complete the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The collection of at least one chronic and one acute donor sample suitable for use in a controlled human infection model (CHIM) measured using review participant case report forms at end-of-study | — |
Secondary
| Measure | Time frame |
|---|---|
| Quantification of HCV viraemia at suitably high levels for use at inoculum measured using blood sample, NHS diagnostic HCV nucleic acid quantification at large donation, day +/-0;Successful cure of inoculum donor defined as sustained virological response at week 12 (SVR12) measured using blood sample, NHS diagnostic HCV nucleic acid quantification at last visit, day +175;The absence of known HCV resistant associated substitutions (RAS) or additional pathogens measured using blood sample: NHS, UKHSA, commercial, and in-house nucleic acid and serological pathogen tests at screening, day -<30; large donation, day +/-0; follow-up, day +86; final visit, day +175 | — |
Countries
England, United Kingdom
Contacts
Public ContactOliver;Eleanor Sampson;Barnes
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Outcome results
None listed