Effect of Direct-acting Antiviral Drugs on Erectile Function | NCT03444272

Studies
Effect of Direct-acting Antiviral Drugs on Erectile Function

NCT03444272

Sponsor

Sherief Abd-Elsalam

Status

Unknown status

Last Update Posted

Oct 22, 2020Actual

Enrollment

105Estimated

Phase

Phase 3

Conditions

Hepatitis C

Interventions

Sofosbuvir and Daklatasuvir

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

Oct 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Feb 19, 2018

First Submission Date that Met QC Criteria

Feb 22, 2018

First Posted Date

Feb 23, 2018Actual

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

Oct 20, 2020

Last Update Posted Date

Oct 22, 2020Actual

Name	Class
Benha University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

105Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hepatitis C Treatment	Experimental	HCV Treatment (Sofosbuvir and Daklatasuvir)	Drug: Sofosbuvir and Daklatasuvir
Supportive treatment	No Intervention	supportive liver therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sofosbuvir and Daklatasuvir	Drug	HCV Treatment (Sofosbuvir and Daklatasuvir)	Hepatitis C Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with improved erectile functions	Number of patients with improved erectile functions	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HCV infected patients
Male

Exclusion Criteria:

HCC
Age below 18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Males

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sherief Abd-Elsalam, MD	Contact	00201095159522		sheriefabdelsalam@yahoo.com
Sherief Abd-Elsalam	Contact			sheriefabdelsalam@yahoo.com

Overall Officials

Name	Affiliation	Role
Sherief Abd-Elsalam, MD	Tanta University	Study Chair
Mohamed Alhefnawy, MD	Tanta University Faculty of medicine	Principal Investigator
Khaled Almekaty, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sherief Abd-Elsalam	Recruiting	Tanta			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006526	Hepatitis C

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069474	Sofosbuvir

Ancestor Terms

ID	Term
D014542	Uridine Monophosphate
D014500	Uracil Nucleotides
D011742	Pyrimidine Nucleotides
D011743	Pyrimidines

Browse Leaves

Not provided

Browse Branches

Not provided