A clinical trial to test the use of a drug called Romiplostim in children after stem cell transplantation for early platelet recovery

Romiplostim in pediatric patients post hematopoietic stem cell transplantation for early platelet engraftment: An open label randomised controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064716

Enrollment

Registered

2024-03-22

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C81-C96- Malignant neoplasms of lymphoid, hematopoietic and related tissue

Interventions

Intervention1: Romiplostim: It is a thrombopoietin receptor agonist. Dose - 5 mcg/kg subcutaneously injected. Two doses on day +1 and +7 (day +5 and +12 for haploidentical ) of transplant. site of i

Eligibility

Inclusion criteria

Inclusion criteria: undergoing allogenic or autologous hematopoietic stem cell transplantation

Exclusion criteria

Exclusion criteria: 1. History of thrombotic events in the past 2. Received thrombopoietic agents in the past 3. non consenting guardian 4. Second transplant 5. Bone marrow not in remission at the transplant 6. Reduced-intensity conditioning transplant 7. Umbilical cord blood transplant

Design outcomes

Primary

Measure	Time frame
To compare the number of days to platelet engraftment, in children aged between 1 and 18 years, post hematopoietic stem cell transplantation, between the control and intervention groups. Timepoint: Day of platelet engraftment (expected between 12-18 days as per retrospective cohort)	—

Secondary

Measure	Time frame
To compare the following parameters between children aged 1 to 18 years requiring stem cell transplantation and controls- Need for platelet transfusions Platelet count at day +28 Depth of platelet nadir Number of significant bleeding episodes Rates of thrombotic eventsTimepoint: Need for platelet transfusions till engraftment thrombotic events clinical follow up till 3 months post last dose of drug	—

Measure

Time frame

To compare the following parameters between children aged 1 to 18 years requiring stem cell transplantation and controls- Need for platelet transfusions Platelet count at day +28 Depth of platelet nadir Number of significant bleeding episodes Rates of thrombotic eventsTimepoint: Need for platelet transfusions till engraftment thrombotic events clinical follow up till 3 months post last dose of drug

—

Countries

India

Contacts

Public ContactDr.Aditya Kumar Gupta

AIIMS, New Delhi

adivick@gmail.com7838379837

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026