Portal Vein ThrombosisPhase 3NCT03193502
Efficacy and Safety of Rivaroxaban in the Management of Acute Non-neoplastic PVT Compensated Cirrhosis
A Phase 3 study testing rivaroxaban in people with Portal Vein Thrombosis, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
-Rivaroxaban is factor Xa inhibitor Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Portal Vein Thrombosis
- What is being tested?
- rivaroxaban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2014to Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Acute PVT
Who cannot join
- Malignant PVT
- Bleeding disorders
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tropical medicine dept.-Tanta university hospital
Cairo
Sherief Abd-Elsalam, 00201095159522, Sherif_tropical@yahoo.com
About this study
Official title: Efficacy and Safety of Rivaroxaban in the Management of Acute Non-neoplastic Portal Vein Thrombosis in HCV Related Compensated Cirrhosis
-Rivaroxaban is factor Xa inhibitor
Read the detailed description
PVT is a common complication of liver cirrhosis
- Conditions
- Portal Vein Thrombosis
- Being tested
- rivaroxaban
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rivaroxabanDrug
Also called xarelto
rivaroxaban
| Study group | Role | What they receive |
|---|---|---|
| Portal Vein thrombosis | Experimental | rivaroxaban Receives: Drug: rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with recanalized portal vein
recanalization of portal vein
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 posted20 Jun 2017
- Study start1 May 2014
- Primary completionJul 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal Vein ThrombosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 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
- Amr Hanafy, Professor, Principal investigator, Hepatology unit - Zagazig UniversityMohamed Basha, Consultant, Study director, Radiology Dept - Zagazig UniversitySherief Abd-elsalam, consultant, Study chair, Hepatology - Gastroenterology - Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193502
- Sponsor's protocol ID
- Amr Hanafy
- Status last verified
- Oct 2017
- First submitted
- 17 Jun 2017
- Last updated
- 13 Oct 2017
- 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 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Rivaroxaban in the Management of Acute Non-neoplastic Portal Vein Thrombosis in HCV Related Compensated Cirrhosis
- ClinicalTrials.gov ID
- NCT03193502
- Acronym / sponsor ID
- Amr Hanafy
- Conditions
- Portal Vein Thrombosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Study start
- 1 May 2014 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 20 Jun 2017 (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.
-Rivaroxaban is factor Xa inhibitor
Detailed description
PVT is a common complication of liver cirrhosis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Portal Vein thrombosis | Experimental | Drug: rivaroxabanrivaroxaban |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Acute PVT
Key exclusion criteria (2 listed)
- Malignant PVT
- Bleeding disorders
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 |
|---|---|---|
| rivaroxabanAlso: xareltorivaroxaban | Drug | Portal Vein thrombosis |
Primary outcome
Number of patients with recanalized portal vein
Time frame: 6 months
recanalization of portal vein
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- 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.
Amr Hanafy, Professor principal investigator
Hepatology unit - Zagazig University
Mohamed Basha, Consultant study director
Radiology Dept - Zagazig University
Sherief Abd-elsalam, consultant study chair
Hepatology - Gastroenterology - 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 rivaroxaban in people with Portal Vein Thrombosis, 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 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 13 Oct 2017. 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, consultant (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 recanalized portal vein (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 13 Oct 2017.