Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT03797066
Eligibility Criteria:
Inclusion Criteria:
1. Participants 18 years or older with chronic hepatitis C genotype 1 or 4 will be eligible.
2. Able and wiling to provide written informed consent.
3. Both interferon treatment naïve and experienced participants will be included.
4. Participants without cirrhosis will be eligible if HCV RNA positive, documented chronic hepatitis C and a FibroScan of ≤ 12.5.
5. Participants with cirrhosis (Fibroscan \> 12.5 or APRI \> 2) will be eligible if the serum albumin is \> 3.5 g/dl, platelets \> 100,000 and INR \< 1.5 and there is no prior history of hepatic decompensation.
6. Participants with well controlled HIV coinfection will be included, but should be stabilized on antiretrovirals for which no clinically significant interaction is expected.
7. Participants who are HBsAg positive will be included, but will require antiviral prophylaxis for HepB. Anti- HbC positive participants will be included. Prophylaxis will not be given, but these participants will require careful monitoring of their ALT levels.
Exclusion Criteria:
* Persons with prior HCV DAA treatment
* Individuals younger than 18 years of age
* Individuals infected with genotypes other than 1a or 1b or 4 HCV identified on screening; however such participants identified on screening will be offered appropriate NHS England standard of treatment for the genotype.
* Unable or unwilling to give informed consent
* Active tuberculosis
* Females who are pregnant, planning pregnancy or breastfeeding
* Concurrent and/or recent involvement in other research that is likely to interfere with the intervention within three months of study enrolment
* Clinically-significant medical or psychiatric illness (other than chronic HCV) in the past, present, or being evaluated, that may interfere with participant treatment, safety, assessment or compliance with the protocol
* Participants with cirrhosis (Fibroscan \> 12.5 or APRI \> 2) and serum albumin is \< 3.5 g/dl, platelets \<100,000 and INR \> 1.5 or a prior history of hepatic decompensation
* Severe renal impairment with eGFR \<30 mL/min/1.73m2 or requiring dialysis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT03797066
Study Brief:
Protocol Section:
NCT03797066