Fixed twelve weeks duration versus response tailored course of dual Sofosbuvir/Daclatasvir therapy in Egyptian adult and adolescent patients with chronic hepatitis C infection (HCV).
Fixed twelve weeks duration versus response tailored course of dual Sofosbuvir/Daclatasvir therapy in Egyptian adult and adolescent patients with chronic hepatitis C infection (HCV). prospective, randomized, open-label, non-inferiority, multi-center study
Green CRC
130 participants
Jun 5, 2016
Interventional
Conditions
Summary
Efficacy and Safety of Gratisovir (Sofosbuvir) - Daclatasvir Dual Therapy in Egyptian adult and Pediatric Patients with Chronic Hepatitis C Infection. A prospective, randomized, open-label, non-inferiority, multi-center Study Objectives: 1. To evaluate the efficacy of Gratisovir (Sofosbuvir) - Daclatasvir dual combination therapy, in Egyptian adult and Pediatric age group patients with chronic hepatitis C. 2. To compare the standard fixed 12 weeks duration of dual SOF/DAC versus a response guided duration of 8/12 in patients with vRVR. 3. To evaluate the safety and tolerability of Sofosbuvir based combination therapy, in Egyptian adult and Pediatric age group patients with chronic hepatitis C 4.. To evaluate the sensitivity and specificity of the very-rapid virologic response as an on-treatment predictor for SVR12. A randomized, open label, non-inferiority, study designed to test efficacy (SVR12) of the combined Sofosbuvir and Daclatasvir and to compare a suggested response guided shortened duration of 8 weeks of therapy versus the recommended 12 weeks duration. Eligible adults and children above 10 years old patients with chronic hepatitis c infection will be included and randomized into 2 groups, group 1 will be treated for a fixed 12 weeks duration of dual therapy and group 2 will be treated according to their virologic response at week 2 for either 8 weeks (for those who will have vRVR) or 12 weeks for the rest. Data will be compared between the 2 groups and the 2 studied durations.
Eligibility
Inclusion Criteria4
- Males or females "greater than or equal to" 18 years & 'less than or equal to' 80 years of age.
- Naive chronically infected with Hepatitis C virus (HCV) as evidenced by a positive HCV viral load for more than 6 months.
- An HCV RNA viral load "greater than or equal to" 10,000 IU/mL at baseline.
- Willing and able to complete all study visits and procedures.
Exclusion Criteria5
- Cirrhosis with Child’s Pugh class C, patients with decompensated cirrhosis, Additionally, patients with cirrhosis are excluded if their AFP is greater than 100ng/ml.
- History of chronic Hepatitis B infection (HBV) [positive test for hepatitis B surface antigen (HBsAg)], or human immunodeficiency virus (HIV) infection [positive test for anti-HIV Ab] or evidence of other cause of hepatitis.
- Pregnant/lactating females or married or intended to marry during the whole study period.
- Uncontrolled diabetes mellitus as evidenced by HbA1C "greater than or equal to" 8.5% at Screening should be treated and blood glucose controlled.
- Creatinine clearance less than 30 mL/minute.
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Interventions
Response guided duration of therapy: Dual treatment with weight based Gratisovir (Sofosbuvir) + weight based Daclatasvir for doses according to the following table: * Gratisovir (Sofosbuvir) 400mg / 200 mg tablets on daily doses based on body weight (20 – 29.9 Kg will take one 200 mg tablet daily); (30 – 39.9 Kg will take 1.5 tablets daily); (> 40 Kg/adults will take 2 tablets (or 1 table of 400 mg) once daily) * + Daclatasvir 60 mg/30 mg tablets on daily doses based on body weight or according to the following schedule: (20 – 30 Kg: will take 30 mg once daily), (31 – 45 Kg: 45 mg once daily) (> 45 Kg/adults: 60 mg once daily) And for a duration tailored according to the very rapid virological response (vRVR) for each patient:: * Those who will show very show rapid virological response (undetectable HCV RNA at week 2) will be treated with 8 weeks duration. * Rest will complete the 12 weeks duration. Adherence to the study protocol and medications will be monitored at each visit by counting the number of pills (if any) remained in the medication packets.
Locations(1)
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ACTRN12617000263392