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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
Sherief Abd-Elsalam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 19, 2018
Last Updated
October 20, 2020
Sponsor
Sherief Abd-Elsalam
Collaborators
Benha University
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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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