NCT06202625 Efficacy and Safety of Avatrombopag in the Treatment of Thrombocytopenia After Haplo-HSCT
| NCT ID | NCT06202625 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Peking University People's Hospital |
| Condition | Thrombocytopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 142 participants |
| Start Date | 2024-05-13 |
| Primary Completion | 2024-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 142 participants in total. It began in 2024-05-13 with a primary completion date of 2024-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this study, investigators aim to evaluate the efficacy of avatrombopag in thrombocytopenic patients after haploidentical hematopoietic stem cell transplantation (haplo-HSCT) through a prospective, multi-center, double-blinded, randomized placebo-controlled clinical trial.
Eligibility Criteria
Inclusion Criteria: 1. Male or female, aged between 18-65 years; 2. PLT\<20×10\^9/L or transfusion dependent on +D7 after haplo-HSCT; 3. Agree to receive the treatment of avatrombopag after Haplo-HSCT and sign the informed consent form. Exclusion Criteria: 1. With active infection; 2. ALT or AST\>3ULN, or total Bil\>2ULN 3. Ccr\<50 mL/min; 4. With the history of arteriovenous thrombosis; 5. With history of cardiovascular disease (such as NYHA Class III/IV congestive heart failure, arrhythmia that increases the risk of thromboembolic events \[such as atrial fibrillation\] and angina), and subjects who have undergone coronary stent implantation, angioplasty, or coronary artery bypass grafting; 6. With treatment of drugs to promote platelet production two weekes before enrollment, including but not limited to rhTPO and TPO-RA; 7. HBsAg or anti-HCV or anti-HIV positive; 8. Known to be allergic to avatrombopag and any of its excipients; 9. With secondary or multiple HSCT; 10. Females who were pregnant or breastfeeding or who had fertile ability but refuse to take effective contraceptive measures during and one month after this trial; 11. With any other clinical trial of investigational product or device within 30 days prior to the baseline visit, except for observational study; 12. Deemed unsuitable for enrollment by the investigator for any history of or concomitant medical condition. 13. Concomitant medication:The rhIL-11, rhTPO or TPO-RA(such as eltrombopag, hetrombopag and romiplostim) and desitabine, etc. were not allowed for use during this trial.
Contact & Investigator
Xiaohui Zhang
PRINCIPAL INVESTIGATOR
Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT06202625 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Thrombocytopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06202625 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06202625 currently recruiting?
Yes, NCT06202625 is actively recruiting participants. Contact the research team at fuhaixia_210@163.com for enrollment information.
Where is the NCT06202625 trial being conducted?
This trial is being conducted at Beijing, China, Guangzhou, China, Shenzhen, China, Harbin, China and 10 additional locations.
Who is sponsoring the NCT06202625 clinical trial?
NCT06202625 is sponsored by Peking University People's Hospital. The principal investigator is Xiaohui Zhang at Peking University People's Hospital. The trial plans to enroll 142 participants.