NCT05854511

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. All enrolled patients will receive daclatasvir 30 mg orally once daily plus sofosbuvir at a dose of 200 mg (2x 100 mg tablets) orally once daily for 12 weeks. Patients will be followed closely for disease progression and any hypersensitivity or adverse reactions due to therapy. Laboratory values to be monitored at baseline are serum creatinine, bilirubin, Aspartate transaminase (AST), Alanine transaminase (ALT), viral load (VL). patients will be recruited in each of two weight bands (14 to \< 17 kg and 17 to 35 kg). The study is mainly powered for non-compartmental pharmacokinetics determination of DCV, SOF and GS-331007. Patient recruitment will be done at Ain Shams university hospitals, Egypt. The study be will conducted after approval by the corresponding research ethical committee and obtaining an informed consent from the parents or the legal guardians, and -whenever applicable- an assent from the patients. Total number of visits is 7 for patients who will complete the study, a screening visits, at the first day of therapy, at weeks 1, 4, 8, 12 and 24 after starting daclatasvir plus sofosbuvir. Patients who will complete their treatment schedule will come after 12 weeks for assessment of SVR. Duration of follow up will be 6 months from treatment initiation in addition to screening period (2-4 weeks).

Conditions

• HCV

Interventions

Type	Name	Description
DRUG	Sofosbuvir 200 MG Oral Tablet plus Daclatasvir 30 mg Oral tablets	Daclatasvir 30 mg orally once daily plus Sofosbuvir at a dose of 200 mg (2x 100 mg tablets) orally once daily for 12 weeks.

Timeline

• Start date: 2022-06-05
• Primary completion: 2023-12-31
• Completion: 2024-04-13
• First posted: 2023-05-11
• Last updated: 2023-05-11

Locations

1 site across 1 country: Egypt