Pharmacokinetics, Safety, Efficacy and Acceptability of Daclatasvir Plus Sofosbuvir in HCV-infected Children

• Status: Recruiting
• Trial end date: 2024-04-13
• Target enrollment: 0
• Participant gender: All

Summary

This is an interventional, single center, single arm clinical trial to assess the pharmacokinetics, safety, efficacy, and acceptability of daclatasvir plus sofosbuvir in treatment-naïve children weighing between 14 and 35 kg with chronic HCV GT 1-6 infection.

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

Details

• Lead Sponsor: Ain Shams University
• Collaborator: Cairo University
• Treatments: Sofosbuvir

Criteria

Inclusion Criteria:

• Children more than 3 years of age and weighing 14-35kg

• Infected with HCV genotypes 1-6

• Treatment Naïve HCV-infected children

• Signing a written consent form by the parent or the legal guardian, and -whenever applicable- an assent by the patient

• Screening laboratory values within predefined thresholds:

1. Absolute neutrophil count ≥ 1,500/mm3

2. Platelets > 50,000 cells/mm3

3. Albumin > 3.5 mg/dL

4. Prothrombin Time PT < 4 sec above control Or International Normalized Ratio INR <1.7 3

5. Random blood glucose level within normal range (> 70 mg/dL and < 200 mg/dL)

6. Serum creatinine < 1.5 mg/dL

Exclusion Criteria:

• Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus

• Clinical hepatic decompensation, i.e., Child-Turcotte-Pugh CTP class B or C (i.e., jaundice, ascites, encephalopathy, or variceal hemorrhage)

• Renal dysfunction, i.e., eGFR < 60 mL/min/1.73 m2 or on regular dialysis as calculated by Schwartz Formula

• Alfa-fetoprotein level > 50 ng/mL

• Chronic liver disease due to a cause other than HCV or Known hypersensitivity to daclatasvir or sofosbuvir.

• History of gastrointestinal disease or gastrointestinal surgical procedure that would impair the absorption of the study drug

• Blood/blood product transfusion within 4 weeks prior to study.

• Systemic corticosteroid administration for more than 2 weeks starting from two weeks before study inclusion and till the end of treatment period (pulmonary/nasal administration is permitted).

• Psychiatric hospitalization, suicide attempt or disability resulting from psychiatric illness within the prior 5 years.

• Ongoing treatment with any medications interacting with daclatasvir/sofosbuvir.