NCT06693791 Romiplostim N01 for Platelet Recovery in Adult Hematologic Malignancies Patients Undergoing UCBT
| NCT ID | NCT06693791 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Anhui Provincial Hospital |
| Condition | Platelet Recovery After Umbilical Cord Blood Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2026-11-01 |
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 34 participants in total. It began in 2024-12-01 with a primary completion date of 2026-11-01.
⚠ 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
To evaluate the efficacy and safety of Romiplostim N01 for platelet recovery after umbilical cord blood transplantation (UCBT) in patients with hematological malignancies.
Eligibility Criteria
Inclusion Criteria: * Age ≥12 years old, male or female; * Patients diagnosed with hematological malignancies 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 Romiplostim N01; * 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 Romiplostim N01; * 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06693791 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Platelet Recovery After Umbilical Cord Blood Transplantation. 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 NCT06693791 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 NCT06693791 currently recruiting?
Yes, NCT06693791 is actively recruiting participants. Contact the research team at xiaoyuz@ustc.edu.cn for enrollment information.
Where is the NCT06693791 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT06693791 clinical trial?
NCT06693791 is sponsored by Anhui Provincial Hospital. The trial plans to enroll 34 participants.