Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Treatment of HCV

HCV Clinical Trial

Official title:

Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Egyptian Patients With HCV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03069001
• Other study ID #: 958
• 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
• 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.

Related Conditions & MeSH terms

• HCV

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