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:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
NCT ID:
NCT03540212
Eligibility Criteria:
Inclusion Criteria:
1. Adolescents (ages 12- 18 years) and/ or weight ≥ 35 kg
2. HCV genotype 4 infected
3. Naïve non-cirrhotic population with FIB Score: F0 to F3.
4. Screening laboratory values within define thresholds
5. Both sex
6. Evidence of HCV infection determined by positive anti-HCV antibody and HCV RNA by polymerase chain reaction (PCR)
7. HCV treatment-naïve
8. Absolute neutrophil count ≥ 1,500/mm3
9. Hemoglobin level ≥ 10 g/dL
10. Platelets \> 75000 cells/mm3
11. Albumin \> 3.5 mg/dL
12. PT \< 3 sec above control and INR within accepted range
13. Random glucose level within normal range
14. Serum creatinine \< 1.5 mg/dL
15. Biopsy is not required for study entry.
16. Signing informed consent by parents and patient assent
Exclusion Criteria:
1. Previous treatment for HCV.
2. History of clinically significant illness or any other medical condition that may interfere with individuals' treatment, assessment, or compliance with protocol.
3. Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus
4. Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage)
5. Pregnant or nursing females
6. Use of any illicit concomitant medications as within 28 days of the Day 1
7. Renal dysfunction
8. Ongoing treatment with Prohibited drugs.
9. Chronic liver disease due to a cause other than HCV e.g. autoimmune disease, Wilson disease,…etc.
10. Alfa-fetoprotein level \>50 ng/mL
11. Serum creatinine \>1.5 mg/dL
12. Simultaneous acute hepatitis A infection
13. Known hypersensitivity to daclatasvir or sofosbuvir
14. History of gastrointestinal disease or surgical procedure
15. Blood /blood product transfusion within 4 weeks prior to study
16. Systemic corticosteroid use for more than 2 weeks (pulmonary/nasal administration was permitted)
17. Psychiatric hospitalization, suicide attempt or disability resulting from psychiatric illness within the prior 5 years
18. Clinically relevant alcohol or drug abuse within 12 months of screening
19. Ongoing treatment with any medications interacting with daclatasvir/sofosbuvir
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
18 Years
Study:
NCT03540212
Study Brief:
Protocol Section:
NCT03540212