Pharmacokinetics, Safety, Efficacy and Acceptability Study of Daclatasvir/Sofosbuvir in Children Weighing 14-35 Kilograms With Chronic Hepatitis C Virus Infection

FMASU P04a / 2022

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.

2022-06-05

2023-12-31

2024-04-13

Recruiting

Early phase I

30

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2023-05-11