Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters
Sponsor
Benha University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05616598
Collaborator
(none)
200
2
2
10
100
10
Study Details
Study Description
Brief Summary
Hepatitis C virus is commona viral infection. Direct-acting antiviral (DAA) oral drugs has been used in treatment of HCVs. the effect of these drugs on male infertility is still under investigation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
Semen analysis will be done to male patients with HCV before and after treatment with DAA. The included men will take therapy for 3 months and HCV RNA titter will be evaluated. changes of seminal parameters will be recorded and analyzed.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
200 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
DAA oral therapy for HCV.DAA oral therapy for HCV.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters
Actual Study Start Date
:
Mar 1, 2022
Anticipated Primary Completion Date
:
Nov 25, 2022
Anticipated Study Completion Date
:
Dec 31, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Pateint group Men with HCV |
Drug: Sofosbuvir +daclatasvir+ simeprevir+Ribavirin
Oral daily dose of Sofosbuvir +daclatasvir + simeprevir+ Ribavirin for 3 months
|
| No Intervention: Control group Men without HCV |
Outcome Measures
Primary Outcome Measures
- Treatment of HCV [3 months]
HCV titer by PCR is below detection level
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
Men patients with HCV
Exclusion Criteria:
Patients with other hepatic disease, endocrinal disorder, malignancy, or urinary tract infection.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Faculty of Medicine, Benha University | Al Qalyūbīyah | Benha | Egypt | |
| 2 | Benha Faculty of Medecine | Banhā | Egypt |
Sponsors and Collaborators
- Benha University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Essam Mohamed El-sayed Akl,
Assistant Professor of Dermatology and Andrology,
Benha University
ClinicalTrials.gov Identifier:
NCT05616598
Other Study ID Numbers:
- RC 39-10-2022
First Posted:
Nov 15, 2022
Last Update Posted:
Nov 15, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Essam Mohamed El-sayed Akl,
Assistant Professor of Dermatology and Andrology,
Benha University
Additional relevant MeSH terms: