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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT03158857
Eligibility Criteria:
Inclusion Criteria:
1. Age \> 18- years, male or female
2. Willing and able to comply with program assessment, including routine tests, attendance for follow up and compliance with medicine taking.
3. Able to provide written agreement (or witnessed in the case of patients who cannot read and write)
4. Have a diagnosis of hepatitis C (based on a hepatitis C point-of-care test and then confirmed by PCR) with or without HIV
Additional inclusion criteria for PK sub-study
1. HIV well-controlled on current therapy (co-infected patients only)
2. Willing and able to comply with the additional blood sampling in the PK-PD sub-study protocol for the duration of the study
Exclusion Criteria
1. Current pregnancy (pregnancy test to be performed in women of child-bearing age)
2. Previous HCV therapy.
3. HCV PCR negative
4. Patients with significant renal impairment with Cr Cl \< 50 ml/min.
5. Known hypersensitivity to any part of the drug regime.
6. Presence of significant comorbidity with life expectancy of less than 12 months.
7. Clinical evidence of decompensated cirrhosis with current or previous episode of ascites, variceal bleed, encephalopathy, and treated hepatocellular cancer (HCC) \[Child-Pugh score B or C\].
8. Presence of concomitant medical or social situation that would make it difficult for the patient to comply with program protocol or put the patient at additional risk
9. Concomitant medications that cause unacceptable drug-drug interactions. Additional exclusion criteria for PK sub-study
1\. Anaemia (Hb \<100 mg/L)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03158857
Study Brief:
Protocol Section:
NCT03158857