Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Treatment of HCV
NCT ID: NCT03069001
Last Updated: 2017-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
90 participants
INTERVENTIONAL
2015-06-30
2016-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sofosbuvir-Simeprevir
* 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.
Sofosbuvir-Simeprevir
-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
* 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.
Sofosbuvir-Ribavirin
-Sofosbuvir-Ribavirin group included 40 patients who received sofosbuvir 400 mg orally once-daily plus ribavirin orally twice-daily for 24 weeks.
Interventions
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Sofosbuvir-Simeprevir
-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
-Sofosbuvir-Ribavirin group included 40 patients who received sofosbuvir 400 mg orally once-daily plus ribavirin orally twice-daily for 24 weeks.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* serum albumin \< 2.8 g/dl.
* INR \> 1.7.
* platelet count \< 50000/mm3.
* serum creatinine \> 2.5 mg/dl.
* patients presented by ascites or hepatic encephalopathy.
* patients with evidence of other causes of liver diseases, including hepatitis A, hepatitis B, autoimmune hepatitis, alcoholic liver disease, drug-induced hepatitis, haemochromatosis, Wilson disease or alpha-1 antitrypsin deficiency.
* patients with any advanced systemic disease.
* pregnancy or inability to use effective contraception in females.
18 Years
70 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Sara Abdelhakam
Assistant Professor
Other Identifiers
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958
Identifier Type: -
Identifier Source: org_study_id
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