Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Treatment of HCV

February 27, 2017 updated by: Sara Abdelhakam, Ain Shams University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Active Comparator: 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.
Drug: Sofosbuvir-Ribavirin
-Sofosbuvir-Ribavirin group included 40 patients who received sofosbuvir 400 mg orally once-daily plus ribavirin orally twice-daily for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

February 23, 2017

First Submitted That Met QC Criteria

February 27, 2017

First Posted (Actual)

March 3, 2017

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 958

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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