A Study of Romiplostim for the Treatment of Refractory Tr... | NCT06535685

NCT06535685

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
Romiplostim group	Experimental	Romiplostim group	Drug: Romiplostim

Name	Type	Description	Arm Group Labels	Other Names
Romiplostim	Drug	Enrolled patients will be given Romiplostim (20 µg/kg subcutaneously once a week) for a minimum of 3 months.	Romiplostim group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall response rate (ORR)	Overall response rate (ORR) was defined as the ratio of complete response (CR) + partial response (PR).CR was defined as a haemoglobin level ≥120 g/L, neutrophil count >1.5 × 10^9/L and platelet count >150 × 10^9/L in patients who did not receive a transfusion.PR was defined as not being transfusion-dependent (if previously transfusion-dependent), or doubling or normalisation of at least one cell line or baseline increase, or initial ANC <0.5 × 10^9/L increased by at least 0.5 × 10^9/L after treatment, or initial PLT <20 × 10^9/L increased by at least 20 × 10^9/L after treatment.	3 months
Overall response rate (ORR)	Overall response rate (ORR) was defined as the ratio of complete response (CR) + partial response (PR).CR was defined as a haemoglobin level ≥120 g/L, neutrophil count >1.5 × 10^9/L and platelet count >150 × 10^9/L in patients who did not receive a transfusion.PR was defined as not being transfusion-dependent (if previously transfusion-dependent), or doubling or normalisation of at least one cell line or baseline increase, or initial ANC <0.5 × 10^9/L increased by at least 0.5 × 10^9/L after treatment, or initial PLT <20 × 10^9/L increased by at least 20 × 10^9/L after treatment.	6 months
CRR	CR was defined as a haemoglobin level ≥120 g/L, neutrophil count >1.5 × 10^9/L and platelet count >150 × 10^9/L in patients who did not receive a transfusion.	3 months
CRR	CR was defined as a haemoglobin level ≥120 g/L, neutrophil count >1.5 × 10^9/L and platelet count >150 × 10^9/L in patients who did not receive a transfusion.	6 months

Secondary Outcomes

Measure	Description	Time Frame
safety events	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	3 months
safety events	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital		Beijing	Beijing Municipality	100730	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
7616805	Background	Young NS. Aplastic anaemia. Lancet. 1995 Jul 22;346(8969):228-32. doi: 10.1016/s0140-6736(95)91273-8. No abstract available.
30354958	Background	Young NS. Aplastic Anemia. N Engl J Med. 2018 Oct 25;379(17):1643-1656. doi: 10.1056/NEJMra1413485. No abstract available.

ID	Term
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D000080983	Bone Marrow Failure Disorders