Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06078969
Status:
RECRUITING
Last Update Posted:
2024-02-01
First Post:
2023-09-27
Brief Title:
Oral Prednisone in Treating LCH of Bone in Childhood and Adolescence
Sponsor:
Shanghai Changzheng Hospital
Organization:
Shanghai Changzheng Hospital
Study Overview
Official Title:
The Efficacy of Oral Prednisone in Treating Langerhans Cell Histiocytosis of Bone in Childhood and Adolescence A Multi-center Open-label Randomized-controlled Phase II Study
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Langerhans cell histiocytosis LCH of bone is a benign-tumor-like osteolytic lesion in childhood and adolescence which is characterized by the aberrant activation of antigen presenting cells Rather than the multi-system involvements of LCH no standard or widely-accepted therapeutic regimens were established for LCH of bone In the previous clinical practice several LCH patients obtained remarkable pain relief after taking prednisone Therefore the investigators aim to conducting a multi-center open-labelled randomized-controlled Phase II study to investigate the efficacy and safety of oral prednisone in treating LCH of bone in children and adolescents The enrolled patients will be randomly recruited to the following groups 1 Oral prednisone Test group 2 Regular observation Control group
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None