Clinical Pharmacokinetics, Safety and Efficacy Study of Daclatasvir/Sofosbuvir in Adolescents Aged 12 to 18 Years Old With Hepatitis C Virus: A Preliminary Study

FMASU P69a/2017

This is an interventional Phase II/III, single center, single arm clinical trial to assess the pharmacokinetics, efficacy, safety and tolerance of daclatasvir plus sofosbuvir in treatment-naïve, non-cirrhotic adolescents with chronic HCV GT-4 infection. A single-arm evaluation of daclatasvir/sofosbuvir will focus on the pharmacokinetics, efficacy and safety All enrolled patients will receive daclatasvir 60 mg orally once daily plus sofosbuvir at a dose of 400 mg orally once daily for 12 weeks.

2017-12-10

2023-04-01

2023-04-01

Recruiting

Early phase I

50

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2023-03-06