Hepatitis CPhase 4NCT03402165
Serum Alpha-fetoprotein Levels and Response to Direct Antiviral Therapy in Patients With Chronic Hepatitis C
A Phase 4 study testing Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir in people with Hepatitis C, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
Alpha-fetoprotein Levels on the Response to direct Antiviral Therapy in Patients with Chronic Hepatitis C Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2017to 30 Dec 2022
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HCV patients who will undergo treatment by direct acting antiviral agents.
Who cannot join
- Patients with decompensated liver disease
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sherief Abd-Elsalam
Tanta
Sherief Abd-elsalam, lecturer, 00201000040794, Sherif_tropical@yahoo.com
About this study
Official title: Impact of Serum Alpha-fetoprotein Levels on the Response to Direct Antiviral Therapy in Egyptian Patients With Chronic Hepatitis C
Alpha-fetoprotein Levels on the Response to direct Antiviral Therapy in Patients with Chronic Hepatitis C
Read the detailed description
Impact of Serum Alpha-fetoprotein Levels on the Response to direct Antiviral Therapy in Egyptian Patients with Chronic Hepatitis C
- Conditions
- Hepatitis C
- Being tested
- Sofosbuvir and Ledipasvir or 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 Ledipasvir or sofosbuvir and daklatasuvirDrug
Also called Sofaldy, Harvony
Response to DAAD's and developing HCC
| Study group | Role | What they receive |
|---|---|---|
| Normal Alfafetoprotein | Experimental | Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir Receives: Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir |
| Mild elevation of alfafetoprotein | Experimental | Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir Receives: Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir |
| High elevation of alfafetoprotein | Experimental | Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir Receives: Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with sustained virologic response
The total number of patients with SVR in each group
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 posted18 Jan 2018
- Study start1 Jan 2017
- Primary completion1 Dec 2022 (estimated)
- Study completion30 Dec 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Rehab Badawi, MD, Principal investigator, Tanta UniversityMohamed Alboraie, MD, Study director, Al-Azhar UniversitySherief Abd-Elsalam, MD, Study director, Tanta UniversityMohamed el kassas, MD, Study director, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402165
- Sponsor's protocol ID
- Alfafetoprotein
- Status last verified
- Aug 2018
- First submitted
- 9 Jan 2018
- Last updated
- 27 Aug 2018
- 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 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Serum Alpha-fetoprotein Levels on the Response to Direct Antiviral Therapy in Egyptian Patients With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT03402165
- Acronym / sponsor ID
- Alfafetoprotein
- Conditions
- Hepatitis C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 18 Jan 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.
Alpha-fetoprotein Levels on the Response to direct Antiviral Therapy in Patients with Chronic Hepatitis C
Detailed description
Impact of Serum Alpha-fetoprotein Levels on the Response to direct Antiviral Therapy in Egyptian Patients with Chronic Hepatitis C
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Alfafetoprotein | Experimental | Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvirSofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir |
| Mild elevation of alfafetoprotein | Experimental | Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvirSofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir |
| High elevation of alfafetoprotein | Experimental | Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvirSofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HCV patients who will undergo treatment by direct acting antiviral agents.
Key exclusion criteria (1 listed)
- Patients with decompensated liver disease
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 Ledipasvir or sofosbuvir and daklatasuvirAlso: Sofaldy, HarvonyResponse to DAAD's and developing HCC | Drug | High elevation of alfafetoprotein, Mild elevation of alfafetoprotein, Normal Alfafetoprotein |
Primary outcome
Number of patients with sustained virologic response
Time frame: 6 months
The total number of patients with SVR in each group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- 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.
Rehab Badawi, MD principal investigator
Tanta University
Mohamed Alboraie, MD study director
Al-Azhar University
Sherief Abd-Elsalam, MD study director
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 4 study testing Sofosbuvir and Ledipasvir or 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 1 inclusion and 1 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 27 Aug 2018. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 sustained virologic response (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 27 Aug 2018.