NCT03444272

Brief Summary

Effect of direct-acting antiviral drugs on erectile function

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2018

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

4.9 years

First QC Date

February 19, 2018

Last Update Submit

October 20, 2020

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Number of patients with improved erectile functions

    Number of patients with improved erectile functions

    6 months

Study Arms (2)

Hepatitis C Treatment

EXPERIMENTAL

HCV Treatment (Sofosbuvir and Daklatasuvir)

Drug: Sofosbuvir and Daklatasuvir

Supportive treatment

NO INTERVENTION

supportive liver therapy

Interventions

Sofosbuvir and DaklatasuvirDRUG

HCV Treatment (Sofosbuvir and Daklatasuvir)

Also known as: Sofaldy, mpiviropack, daklanork
Hepatitis C Treatment

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMales
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HCV infected patients
  • Male

You may not qualify if:

  • HCC
  • Age below 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Sherief Abd-Elsalam, MD

    Tanta University

    STUDY CHAIR

  • Mohamed Alhefnawy, MD

    Tanta University Faculty of medicine

    PRINCIPAL INVESTIGATOR

  • Khaled Almekaty, MD

    Tanta University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherief Abd-Elsalam, MD

CONTACT

00201095159522sheriefabdelsalam@yahoo.com

Sherief Abd-Elsalam

CONTACT

sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhDTropical Medicine

Study Record Dates

First Submitted

February 19, 2018

First Posted

February 23, 2018

Study Start

January 1, 2018

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

October 22, 2020

Record last verified: 2020-10

Locations

EG(1)