Romiplostim N01 for Platelet Recovery in Adult Hematologic Malignancies Patients Undergoing UCBT
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnhui Provincial Hospital
About this trial
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
Qualifiers
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
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Romiplostim N01
Treatment groups
34 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov