Ropustin for Refractory Aplastic Anaemia After Radiothera... | NCT06516484

NCT06516484

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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Romiplostim group	Experimental	Enrolled patients were given roprostin (20 µg/kg subcutaneously once weekly) for at least 3 months, with discontinuation of roprostin for platelet counts ≥50 x 10^9/L and continuation of roprostin for platelet counts <50 x 10^9/L. Responders were continued to 6 months. Responders continue to use the drug until 6 months.	Drug: Romiplostim

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Romiplostim	Drug	Enrolled patients were given roprostin (20 µg/kg subcutaneously once weekly) for at least 3 months, with discontinuation of roprostin for platelet counts ≥50 x 10^9/L and continuation of roprostin for platelet counts <50 x 10^9/L. Responders were continued to 6 months. Responders continue to use the drug until 6 months.

Outcomes Module

Primary Outcomes

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

Measure	Description	Time Frame
safety events	Proportion and severity of adverse events in patients during the study period	3 months，6months

Eligibility Module

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Bing Han, PhD	Contact	+8613601059938		Hanbing_li@sina.com.cn
Leyu Wang	Contact	18239490957		wangleyu_ys@163.com

Name	Affiliation	Role
Bing Han, PhD	Peking Union Medical College	Principal Investigator

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
23821332	Background	Kuter DJ. The biology of thrombopoietin and thrombopoietin receptor agonists. Int J Hematol. 2013 Jul;98(1):10-23. doi: 10.1007/s12185-013-1382-0. Epub 2013 Jul 3.
31474546	Background	Lee JW, Lee SE, Jung CW, Park S, Keta H, Park SK, Kim JA, Oh IH, Jang JH. Romiplostim in patients with refractory aplastic anaemia previously treated with immunosuppressive therapy: a dose-finding and long-term treatment phase 2 trial. Lancet Haematol. 2019 Nov;6(11):e562-e572. doi: 10.1016/S2352-3026(19)30153-X. Epub 2019 Aug 29.

IPD Sharing Statement Module

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