A Phase 4 interventional study of Sofosbuvir-Simeprevir and Sofosbuvir-Ribavirin in HCV, sponsored by Ain Shams University. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-03-03.
Sponsored by Ain Shams University · Phase 4, Interventional, and Treatment
This prospective study was conducted at Ain Shams University Hospital, Internal Medicine, Hepatology and Gastroenterology Department, and Tropical Medicine Department.
To compare the efficacy of the combination of sofosbuvir and simeprevir for 12 weeks with the combination of sofosbuvir and ribavirin for 24 weeks in Egyptian patients with HCV-related Child A cirrhosis.
Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 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.
Exclusion Criteria:
* Sofosbuvir 400 mg orally once-daily. * Simeprevir 150 mg orally once-daily. * Group A included 50 patients who received sofosbuvir 400 mg orally once-daily plus simeprevir 150 mg orally once-daily for 12 weeks.
Drug: Sofosbuvir-Simeprevir
* Sofosbuvir 400 mg orally once-daily. * Ribavirin orally twice-daily (according to body weight: 1000 mg daily in patients with a body weight of \<75 kg and 1200 mg daily in patients with a body weight of ≥75 kg). * Group B included 40 patients who received sofosbuvir 400 mg orally once-daily plus ribavirin orally twice-daily for 24 weeks.
Drug: Sofosbuvir-Ribavirin
-Sofosbuvir-Simeprevir group included 50 patients who received sofosbuvir 400 mg orally once-daily plus simeprevir 150 mg orally once-daily for 12 weeks.
-Sofosbuvir-Ribavirin group included 40 patients who received sofosbuvir 400 mg orally once-daily plus ribavirin orally twice-daily for 24 weeks.
Evaluation at end-of-treatment response
undetectable HCV-RNA 12 weeks after the completion of therapy by a sensitive HCV-RNA assay
Time frame: 12 weeks
No study locations are listed for this record.
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Ain Shams University