BridgeMD
New treatment option for Platelet Recovery After Umbilical Cord Blood Transplantation
Official title Romiplostim N01 for Platelet Recovery in Adult Hematologic Malignancies Patients Undergoing UCBT
ClinicalTrials.gov ID: NCT06693791
What this study is testing
What is Romiplostim N01?
Romiplostim N01 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for platelet recovery after umbilical cord blood transplantation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the efficacy and safety of Romiplostim N01 for platelet recovery after umbilical cord blood transplantation (UCBT) in patients with hematological malignancies.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Chronic active hepatitis B and C;
- Repeat or multiple transplantation or multiple organ transplantation;
See the full eligibility 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
- 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;
- people with cognitive impairment or uncontrolled mental illness;
- people 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 people or it is estimated that the treatment cannot be adhered to due to...
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.