Effect of Direct-acting Antiviral Drugs on Erectile Function
Primary Purpose
Hepatitis C
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Sofosbuvir and Daklatasuvir
Sponsored by

About this trial
This is an interventional treatment trial for Hepatitis C
Eligibility Criteria
Inclusion Criteria:
- HCV infected patients
- Male
Exclusion Criteria:
- HCC
- Age below 18 years
Sites / Locations
- Sherief Abd-ElsalamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Hepatitis C Treatment
Supportive treatment
Arm Description
HCV Treatment (Sofosbuvir and Daklatasuvir)
supportive liver therapy
Outcomes
Primary Outcome Measures
Number of patients with improved erectile functions
Number of patients with improved erectile functions
Secondary Outcome Measures
Full Information
NCT ID
NCT03444272
First Posted
February 19, 2018
Last Updated
October 20, 2020
Sponsor
Sherief Abd-Elsalam
Collaborators
Benha University
1. Study Identification
Unique Protocol Identification Number
NCT03444272
Brief Title
Effect of Direct-acting Antiviral Drugs on Erectile Function
Official Title
Effect of Direct-acting Antiviral Drugs on Erectile Function Among Hepatitis c Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
Collaborators
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Effect of direct-acting antiviral drugs on erectile function
Detailed Description
Effect of direct-acting antiviral drugs on erectile function in HCV patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hepatitis C Treatment
Arm Type
Experimental
Arm Description
HCV Treatment (Sofosbuvir and Daklatasuvir)
Arm Title
Supportive treatment
Arm Type
No Intervention
Arm Description
supportive liver therapy
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir and Daklatasuvir
Other Intervention Name(s)
Sofaldy, mpiviropack, daklanork
Intervention Description
HCV Treatment (Sofosbuvir and Daklatasuvir)
Primary Outcome Measure Information:
Title
Number of patients with improved erectile functions
Description
Number of patients with improved erectile functions
Time Frame
6 months
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Males
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HCV infected patients
Male
Exclusion Criteria:
HCC
Age below 18 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, MD
Phone
00201095159522
Email
sheriefabdelsalam@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam
Email
sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam, MD
Organizational Affiliation
Tanta University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohamed Alhefnawy, MD
Organizational Affiliation
Tanta University Faculty of medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Khaled Almekaty, MD
Organizational Affiliation
Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-elsalam, lecturer
Phone
00201000040794
Email
Sherif_tropical@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Direct-acting Antiviral Drugs on Erectile Function
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