Effect of New Oral Treatment for Hepatitis C Virus on Sem... | NCT05616598

Studies
Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters

NCT05616598

Sponsor

Benha University

Status

Completed

Last Update Posted

Feb 8, 2023Actual

Enrollment

200Actual

Phase

Phase 2Phase 3

Conditions

Male Infertility
HCV

Interventions

Sofosbuvir +daclatasvir+ simeprevir+Ribavirin

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2022Actual

Primary Completion Date

Nov 25, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Nov 1, 2022

First Submission Date that Met QC Criteria

Nov 7, 2022

First Posted Date

Nov 15, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2023

Last Update Posted Date

Feb 8, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Essam Mohamed El-sayed Akl, Assistant Professor of Dermatology and Andrology, Benha UniversityPrincipal Investigator

Lead Sponsor

Benha UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pateint group	Active Comparator	Men with HCV	Drug: Sofosbuvir +daclatasvir+ simeprevir+Ribavirin
Control group	No Intervention	Men without HCV

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sofosbuvir +daclatasvir+ simeprevir+Ribavirin	Drug	Oral daily dose of Sofosbuvir +daclatasvir + simeprevir+ Ribavirin for 3 months	Pateint group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment of HCV	HCV titer by PCR is below detection level	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men patients with HCV

Exclusion Criteria:

Patients with other hepatic disease, endocrinal disorder, malignancy, or urinary tract infection.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Men patients with HCV

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Benha University		Al Qalyūbīyah	Benha		Egypt
Benha Faculty of Medecine

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007248	Infertility, Male

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007246	Infertility

Browse Leaves

Not provided

Browse Branches

Not provided