Using Avatrombopag to Help Platelet Recovery After Cord Blood Transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the efficacy and safety of Avatrombopag in promoting platelet recovery in patients with bone marrow failure disease following umbilical cord blood transplantation (UCBT). It is a single-center, single-arm phase II trial involving patients diagnosed with various forms of bone marrow failure who are undergoing UCBT. Participants will receive Avatrombopag treatment from the first day to the 28th day post-transplantation, with the primary outcome being the cumulative platelet implantation rate at 28 days. A total of 40 patients are planned for enrollment in this study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥12 years old, male or female;
* Patients diagnosed with bone marrow failure disease including aplastic anemia (AA), Fanconi anemia (FA), paroxysmal nocturnal hemoglobinuria (PNH) and undergoing UCBT;
* ECOG score ≤2;
* Voluntary participation in this clinical trial, patients fully understand the trial content and sign the informed consent；

Exclusion Criteria:

* Pregnant or lactating women；
* Known allergy to Avatrombopag;
* A history of severe thrombotic events or known risk factors for thrombosis or active thromboembolism requiring anticoagulation;
* A history of platelet dysfunction or bleeding prone disease or severe bleeding (requiring more than 2 units of red blood cell infusion or a hematocrit drop of ≥10%) within 7 days prior to screening;
* Chronic active hepatitis B and C;
* Repeat or multiple transplantation or multiple organ transplantation;
* HIV positive, EBV-DNA positive, CMV-DNA positive;
* Have severe infection or complicated with serious heart, liver, lung, kidney, neurological or metabolic diseases;
* A serious adverse event (Level 4 or 5) as defined by the Standard General Terminology for Adverse Events Version 4.0 occurred during the pre-treatment period;
* Participants participate in another clinical study with any exploratory drug or device within 30 days prior to baseline visit; Observational studies are allowed;
* Subjects with cognitive impairment or uncontrolled mental illness;
* Subjects and/or authorized family members to refuse treatment with Avatrombopag;
* Those who are judged by the researchers as not suitable for inclusion (such as accompanying medical history, which may affect the safety of the subjects or it is estimated that the treatment cannot be adhered to due to financial problems).

Where it's running

• The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
  Hefei, Anhui, China Recruiting

Study contacts

• Principal investigator: Xiaoyu Zhu, ph.D — The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
• Study coordinator: Xiaoyu Zhu, ph.D
• Email: xiaoyuz@ustc.edu.cn
• Phone: 15255456091

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using Romiplostim N01 to help platelet recovery after umbilical cord blood transplantation

  This study is testing if a medication called Romiplostim N01 can help adults recover their platelet levels faster after receiving umbilical cord blood transplants.

  Recruiting Phase 2 Anhui Provincial Hospital · Hefei, Anhui · NCT06693791

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.