CClinicalTrials.gg
Status unknownNCT03444272Updated Oct 22, 2020

Effect of Direct-acting Antiviral Drugs on Erectile Function

A Phase 3 interventional study of Sofosbuvir and Daklatasuvir in Hepatitis C, sponsored by Sherief Abd-Elsalam. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-22.

Sponsored by Sherief Abd-Elsalam · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Effect of direct-acting antiviral drugs on erectile function

Read the detailed description

Effect of direct-acting antiviral drugs on erectile function in HCV patients

02

Conditions studied

  • Hepatitis C
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • HCV infected patients
  • Male

Exclusion criteria

Exclusion Criteria:

  • HCC
  • Age below 18 years
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
105 participants (estimated)

Study arms

  • Experimental
    Hepatitis C Treatment

    HCV Treatment (Sofosbuvir and Daklatasuvir)

    Drug: Sofosbuvir and Daklatasuvir

  • No intervention
    Supportive treatment

    supportive liver therapy

Interventions

  • DrugSofosbuvir and Daklatasuvir

    HCV Treatment (Sofosbuvir and Daklatasuvir)

    Also known as: Sofaldy, mpiviropack, daklanork

05

What researchers measure

Primary outcomes

  1. Number of patients with improved erectile functions

    Number of patients with improved erectile functions

    Time frame: 6 months

06

Study locations

1 of 1 sites recruiting
  • Sherief Abd-Elsalam
    Tanta, Egypt
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03444272
Lead sponsor
Sherief Abd-Elsalam
Collaborators
Benha University
Responsible party
Sherief Abd-Elsalam (PhDTropical Medicine, Tanta University) — Sponsor-investigator
First posted
Feb 23, 2018
Start date
Jan 1, 2018
Primary completion
Dec 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Oct 22, 2020

Study contacts

Sherief Abd-Elsalam, MD
Contact
sheriefabdelsalam@yahoo.com
00201095159522
Sherief Abd-Elsalam
Contact
sheriefabdelsalam@yahoo.com
Sherief Abd-Elsalam, MD
study chair · Tanta University
Mohamed Alhefnawy, MD
principal investigator · Tanta University Faculty of medicine
Khaled Almekaty, MD
principal investigator · Tanta University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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