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Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Treatment of HCV

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT03069001
Collaborator
(none)
90
Enrollment
2
Arms
9
Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Egyptian Patients With HCV
Actual Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Evaluation at end-of-treatment response [12 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sara Abdelhakam, Assistant Professor, Ain Shams University
ClinicalTrials.gov Identifier:
NCT03069001
Other Study ID Numbers:
  • 958
First Posted:
Mar 3, 2017
Last Update Posted:
Mar 3, 2017
Last Verified:
Feb 1, 2017
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sara Abdelhakam, Assistant Professor, Ain Shams University
HCV treatment
Additional relevant MeSH terms:
Ribavirin
Sofosbuvir
Simeprevir

Study Results

No Results Posted as of Mar 3, 2017