HCV Clinical Trial
Official title:
Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Egyptian Patients With HCV
Verified date | February 2017 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Patients with chronic HCV infection with a positive HCV RNA level by PCR. Exclusion Criteria: - Total bilirubin > 2 mg/dl. - 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation at end-of-treatment response | undetectable HCV-RNA 12 weeks after the completion of therapy by a sensitive HCV-RNA assay | 12 weeks |
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