Clinical Pharmacokinetics of Daclatasvir/Sofosbuvir in Adolescents With Hepatitis C Virus

• Status: Unknown status
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Sofosbuvir

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