A Phase 3 interventional study of Sofosbuvir 200 MG Oral Tablet plus Daclatasvir 30 mg Oral tablets in HCV, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2023-05-11.
Sponsored by Ain Shams University · Phase 3, Interventional, and Treatment
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.
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).
Ain Shams University is the lead sponsor of 1,879 studies on the registry; 424 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Screening laboratory values within predefined thresholds:
Exclusion Criteria:
treatment-naïve children infected with chronic HCV will be stratified according to weight 1. Children weighing 14 \<17 Kg 2. Children weighting 17\<35 Kg
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.
Also known as: Daklinza, Sovaldi
Plasma concentration of Daclatasvir
The plasma concentration of Daclatasvir on day 8 will be used to derive the Pharmacokinetic parameters using the Non-Compartmental analysis (NCA)
Time frame: one week
Plasma concentration of Sofosbuvir
The plasma concentration of Daclatasvir on day 8 will be used to derive the Pharmacokinetic parameters using the Non-Compartmental analysis (NCA)
Time frame: one week
Efficacy of Daclatasvir 30 MG oral tablets and Sofosbuvir 200 MG oral tablets once daily for 12 weeks
Efficacy will be assessed via sustained virologic response at 12 weeks after the 12 weeks treatment completion (SVR12)
Time frame: 24 weeks
Safety of Daclatasvir 30 MG oral tablets and Sofosbuvir 200 MG oral tablets once daily for 12 weeks
Safety o will be assessed by recording any adverse event occurs in treatment period and 2-4 weeks after the last visit (after week 24)
Time frame: 24 weeks
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Ain Shams University