Skip to main content
OpenTrials
Completed

NCT Number: NCT03069001

Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Treatment of HCV

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HCV

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sofosbuvir-Simeprevir

Drug

-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

Drug

-Sofosbuvir-Ribavirin group included 40 patients who received sofosbuvir 400 mg orally once-daily plus ribavirin orally twice-daily for 24 weeks.

Primary outcomes

  1. Evaluation at end-of-treatment response

    Time frame: 12 weeks

    undetectable HCV-RNA 12 weeks after the completion of therapy by a sensitive HCV-RNA assay

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 3, 2017
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.