Hepatitis CPhase 3NCT03444272
Effect of Direct-acting Antiviral Drugs on Erectile Function
A Phase 3 study testing Sofosbuvir and Daklatasuvir in people with Hepatitis C, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
Effect of direct-acting antiviral drugs on erectile function Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Sofosbuvir and Daklatasuvir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HCV infected patients
- Male
Who cannot join
- HCC
- Age below 18 years
Trial locations and contacts
1 site in 1 country.
Sherief Abd-Elsalam contact
Egypt1 site, 1 recruiting
- Recruiting
Sherief Abd-Elsalam
Tanta
Sherief Abd-elsalam, lecturer, 00201000040794, Sherif_tropical@yahoo.com
About this study
Official title: Effect of Direct-acting Antiviral Drugs on Erectile Function Among Hepatitis c Patients
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
- Conditions
- Hepatitis C
- Being tested
- Sofosbuvir and Daklatasuvir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir and DaklatasuvirDrug
Also called Sofaldy, mpiviropack, daklanork
HCV Treatment (Sofosbuvir and Daklatasuvir)
| Study group | Role | What they receive |
|---|---|---|
| Hepatitis C Treatment | Experimental | HCV Treatment (Sofosbuvir and Daklatasuvir) Receives: Drug: Sofosbuvir and Daklatasuvir |
| Supportive treatment | No intervention | supportive liver therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with improved erectile functions
Number of patients with improved erectile functions
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start1 Jan 2018
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Sherief Abd-Elsalam, MD, Study chair, Tanta UniversityMohamed Alhefnawy, MD, Principal investigator, Tanta University Faculty of medicineKhaled Almekaty, MD, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444272
- Sponsor's protocol ID
- HCV TREATMENT
- Status last verified
- Oct 2020
- First submitted
- 19 Feb 2018
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Direct-acting Antiviral Drugs on Erectile Function Among Hepatitis c Patients
- ClinicalTrials.gov ID
- NCT03444272
- Acronym / sponsor ID
- HCV TREATMENT
- Conditions
- Hepatitis C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Collaborators
- Benha University
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effect of direct-acting antiviral drugs on erectile function
Detailed description
Effect of direct-acting antiviral drugs on erectile function in HCV patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hepatitis C Treatment | Experimental | Drug: Sofosbuvir and DaklatasuvirHCV Treatment (Sofosbuvir and Daklatasuvir) |
| Supportive treatment | No intervention | –supportive liver therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HCV infected patients
- Male
Key exclusion criteria (2 listed)
- HCC
- Age below 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sofosbuvir and DaklatasuvirAlso: Sofaldy, mpiviropack, daklanorkHCV Treatment (Sofosbuvir and Daklatasuvir) | Drug | Hepatitis C Treatment |
Primary outcome
Number of patients with improved erectile functions
Time frame: 6 months
Number of patients with improved erectile functions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherief Abd-Elsalam contact
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sofosbuvir and Daklatasuvir in people with Hepatitis C, run by Sherief Abd-Elsalam at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-Elsalam, MD (00201095159522, sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with improved erectile functions (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.