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An Experiment the Size of Egyptian Village

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ClinicalTrials.gov Identifier: NCT03444272
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Collaborator:
Ain Shams University
Information provided by (Responsible Party):
Tanta University

Brief Summary:
Sofosbuvir plus Daclatasvir in Treatment of Chronic Hepatitis C Genotype 4 Infection in a cohort of Egyptian patients: an experiment the size of Egyptian village

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Sofosbuvir and Daklatasuvir Phase 3

Detailed Description:
A more interesting part is the epidemiology and the actual percentage of persons that were reached and treated in this study. The introduction of novel direct acting antiretroviral drugs in treating hepatitis C in Egypt has led to widespread treatment to become the largest program to treat hepatitis C virus worldwide.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sofosbuvir Plus Daclatasvir in Treatment of Chronic Hepatitis C Genotype 4 Infection in a Cohort of Egyptian Patients: an Experiment the Size of Egyptian Village
Actual Study Start Date : March 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Hepatitis C patients
HCV Treatment (Sofosbuvir and Daklatasuvir)
Drug: Sofosbuvir and Daklatasuvir
HCV Treatment (Sofosbuvir and Daklatasuvir)
Other Name: Sofaldy, mpiviropack, daklanork



Primary Outcome Measures :
  1. Number of patients with sustained virological response [ Time Frame: 6 months ]
    Number of patients treated from chronic HCV



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HCV infected patients

Exclusion Criteria:

  • HCC
  • Pregnancy
  • Age below 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444272


Contacts
Contact: Sherief Abd-Elsalam, MD 00201095159522 sheriefabdelsalam@yahoo.com
Contact: Sherief Abd-Elsalam sheriefabdelsalam@yahoo.com

Locations
Egypt
Sherief Abd-Elsalam Recruiting
Tanta, Egypt
Contact: Sherief Abd-elsalam, lecturer    00201000040794    Sherif_tropical@yahoo.com   
Sponsors and Collaborators
Tanta University
Ain Shams University
Investigators
Principal Investigator: Ossama Ashraf, MD Ain Shams University
Study Director: Ahmed Hassan Fouad, MD Ain Shams University
Study Director: Eslam Safwat, MD Ain Shams University
Study Chair: Mohamed Omar Khalifa, MD Ain Shams University
Study Chair: Ahmed I. Elshafie, MD Ain Shams University
Study Chair: Gina Gamal Naguib, MD Ain Shams University
Study Chair: Sherief Abd-Elsalam, MD Tanta University

Responsible Party: Tanta University
ClinicalTrials.gov Identifier: NCT03444272     History of Changes
Other Study ID Numbers: HCV TREATMENT
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Sofosbuvir
Antiviral Agents
Anti-Infective Agents