Pharmacokinetics, Safety, Efficacy and Acceptability Study of Daclatasvir/Sofosbuvir in Children Weighing 14-35 Kilograms With Chronic Hepatitis C Virus Infection
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.
• 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:
‣ Absolute neutrophil count ≥ 1,500/mm3
⁃ Platelets \> 50,000 cells/mm3
⁃ Albumin \> 3.5 mg/dL
⁃ Prothrombin Time PT \< 4 sec above control Or International Normalized Ratio INR \<1.7 3
⁃ Random blood glucose level within normal range (\> 70 mg/dL and \< 200 mg/dL)
⁃ Serum creatinine \< 1.5 mg/dL