Hepatic Artery ThrombosisPhase 3Tip-HATNCT04946929
Ticagrelor in Post-transplant Patients With Pediatric Hepatic Artery Thrombosis (HAT)
A Phase 3 study testing Ticagrelor Oral Tablet [Brilinta] and Low molecular weight heparin in people with Hepatic Artery Thrombosis and Liver Transplant; Complications, run by RenJi Hospital at 1 site in China.
Trial summary
Hepatic artery thrombosis (HAT) represents a major cause of graft loss and mortality after Pediatric liver transplantation. Ticagrelor (a new reversible inhibitor of P2Y12 receptor with faster onset of action and greater platelet inhibition) was used to treat patients with pediatric post-transplant hepatic artery… Read more about this study
- Who is it for?
- Ages 2 months to 5 years
- Conditions the study is for
- Hepatic Artery Thrombosis, Liver Transplant; Complications, Pediatric Disease
- What is being tested?
- Ticagrelor Oral Tablet [Brilinta] and Low molecular weight heparin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2021to 31 Mar 2023
- 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 2 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age from 2 months to 5 years old.
- voluntary participation in clinical trials, and informed consent;
- Contrast- Enhanced Ultrasonography proved HAT
Who cannot join
- History of sensitivity to study medications or any of their excipients
- Renal failure (eGFR <30 or requiring dialysis)
- A known bleeding diathesis, hemostatic or coagulation disorder, or prior major bleeding
- Prior stroke
- Active pathological bleeding
- History of intracranial haemorrhage
Show all 11Show fewer
- Life expectancy <12 months based on investigator's judgement
- Patients considered to be at risk of bradycardic events (e.g., known sick sinus syndrome or second or third degree atrioventricular [AV)] block) unless already treated with a permanent pacemaker
- Anemia (hematocrit < 27%)
- Platelet count < 100,000/ml
- Concomitant use of strong CYP 3A inhibitors or inducers
Trial locations and contacts
1 site in 1 country.
China1 site
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, 200127
About this study
Official title: Determine the Safety/Efficacy of Ticagrelor in Post-transplant Patients With Hepatic Artery Thrombosis (HAT)
Hepatic artery thrombosis (HAT) represents a major cause of graft loss and mortality after Pediatric liver transplantation. Ticagrelor (a new reversible inhibitor of P2Y12 receptor with faster onset of action and greater platelet inhibition) was used to treat patients with pediatric post-transplant hepatic artery thrombosis (HAT) compared to low molecular weight heparin.
Read the detailed description
In pediatric patients with post-transplant hepatic artery thrombosis (HAT) , low molecular weight heparin is a commonly used method. Ticagrelor, a direct-acting and reversible ADP receptor antagonist, is now the most commonly used ADP receptor antagonist in the treatment of coronary diseases. Compared to its predecessor clopidogrel, the pharmacokinetic profil of ticagrelor is more predictable, demonstrating a faster onset of action and a more consistent platelet inhibition. However, because of the excellent antithrombotic effect and increased bleeding potential, it is recommended that major bleeding, such as OPCAB or CABG surgery, be expected with a high probability, and in case of fatal surgery, the drug should be discontinued for 5 days. The present study is to evaluate the safety and efficacy of Ticagrelor in pediatirc receipt with post-operative HAT.
- Being tested
- Ticagrelor Oral Tablet [Brilinta], Low molecular weight heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor Oral Tablet [Brilinta]Drug
Also called Ticagrelor
Ticagrelor, 2-3mg/kg, 12h, p.o.
Low molecular weight heparinDrug
half amount low molecular weight heparin
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor, 2-3mg/kg, 12h | Experimental | 2-3mg/kg, q12h, p.o. for 2w Receives: Drug: Ticagrelor Oral Tablet [Brilinta] |
| low molecular weight heparin | Active comparator | half amount low molecular weight heparin Receives: Drug: Low molecular weight heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast-Enhanced Ultrasonography-Based Hepatic Perfusion Index
The peak systolic maximum velocity (Vmax) of the HA, and HA resistive index (HARI)
Measured: 3 months
Secondary outcomes (2)
High on-treatment platelet reactivity (HPR)
HPR defined as platelet reactivity index (PRI) ≥50% using VASP analysis
Measured: Two hours after the injection of either active drug or placebo
Post-operative major bleeding event
post-operative major bleeding defined as HAT related bleeding
Measured: within 72 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start31 Jul 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Artery ThrombosisStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hao Feng, MD. Ph.D, Principal investigator, Dept. Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of MedicineChuan Shen, MD, Principal investigator, Dept. Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of MedicineXiaosong Chen, MD, Study director, Dept. Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of MedicineQiang XIA, MD. Ph.D, Study chair, Dept. Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946929
- Sponsor's protocol ID
- KY2021-083
- Acronym
- Tip-HAT
- Status last verified
- Jun 2021
- First submitted
- 23 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determine the Safety/Efficacy of Ticagrelor in Post-transplant Patients With Hepatic Artery Thrombosis (HAT)
- ClinicalTrials.gov ID
- NCT04946929
- Acronym / sponsor ID
- Tip-HAT / KY2021-083
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 31 Jul 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 1 Jul 2021 (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.
Hepatic artery thrombosis (HAT) represents a major cause of graft loss and mortality after Pediatric liver transplantation. Ticagrelor (a new reversible inhibitor of P2Y12 receptor with faster onset of action and greater platelet inhibition) was used to treat patients with pediatric post-transplant hepatic artery thrombosis (HAT) compared to low molecular weight heparin.
Detailed description
In pediatric patients with post-transplant hepatic artery thrombosis (HAT) , low molecular weight heparin is a commonly used method. Ticagrelor, a direct-acting and reversible ADP receptor antagonist, is now the most commonly used ADP receptor antagonist in the treatment of coronary diseases. Compared to its predecessor clopidogrel, the pharmacokinetic profil of ticagrelor is more predictable, demonstrating a faster onset of action and a more consistent platelet inhibition. However, because of the excellent antithrombotic effect and increased bleeding potential, it is recommended that major bleeding, such as OPCAB or CABG surgery, be expected with a high probability, and in case of fatal surgery, the drug should be discontinued for 5 days. The present study is to evaluate the safety and efficacy of Ticagrelor in pediatirc receipt with post-operative HAT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor, 2-3mg/kg, 12h | Experimental | Drug: Ticagrelor Oral Tablet [Brilinta]2-3mg/kg, q12h, p.o. for 2w |
| low molecular weight heparin | Active comparator | Drug: Low molecular weight heparinhalf amount low molecular weight heparin |
Who may qualify
- Ages
- 2 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age from 2 months to 5 years old.
- voluntary participation in clinical trials, and informed consent;
- Contrast- Enhanced Ultrasonography proved HAT
Key exclusion criteria (11 listed)
- History of sensitivity to study medications or any of their excipients
- Renal failure (eGFR <30 or requiring dialysis)
- A known bleeding diathesis, hemostatic or coagulation disorder, or prior major bleeding
- Prior stroke
- Active pathological bleeding
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 |
|---|---|---|
| Ticagrelor Oral Tablet [Brilinta]Also: TicagrelorTicagrelor, 2-3mg/kg, 12h, p.o. | Drug | Ticagrelor, 2-3mg/kg, 12h |
| Low molecular weight heparinhalf amount low molecular weight heparin | Drug | low molecular weight heparin |
Primary outcome
Contrast-Enhanced Ultrasonography-Based Hepatic Perfusion Index
Time frame: 3 months
The peak systolic maximum velocity (Vmax) of the HA, and HA resistive index (HARI)
2 secondary outcomes
High on-treatment platelet reactivity (HPR)
Time frame: Two hours after the injection of either active drug or placebo
Post-operative major bleeding event
Time frame: within 72 hours after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
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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.
Hao Feng, MD. Ph.D principal investigator
Dept. Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Chuan Shen, MD principal investigator
Dept. Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Xiaosong Chen, MD study director
Dept. Liver Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine
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 Ticagrelor Oral Tablet [Brilinta] and Low molecular weight heparin in people with Hepatic Artery Thrombosis and Liver Transplant; Complications, run by RenJi Hospital at 1 site in China.
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 3 inclusion and 11 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 1 Jul 2021. 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 China. 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 Hao Feng, MD. Ph.D (+8615000901110, surgeonfeng@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast-Enhanced Ultrasonography-Based Hepatic Perfusion Index (time frame: 3 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 1 Jul 2021.