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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03069001
Other study ID # 958
Secondary ID
Status Completed
Phase Phase 4
First received February 23, 2017
Last updated February 27, 2017
Start date June 2015
Est. completion date March 2016

Study information

Verified date February 2017
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Outcome

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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