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Oral Prednisone in Treating LCH of Bone in Childhood and Adolescence

RecruitingPhase 2Ages 2 Years - 17 YearsAllShanghai Changzheng Hospital
NCT06078969 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 \[Control group\].

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📋 Eligibility rules (as published)
Inclusion Criteria: * Pathological diagnosis of Langerhans cell histiocytosis (LCH) of bone; * Single-system involvement (skeletal system); * No need of surgical intervention; * Must be able to swallow tablets; * Signing informed consent form. Exclusion Criteria: * Multi-system involvements (≥2 systems, including bone, liver, spleen, hematologic system, central nerve system); * Need of surgical intervention (e.g. pathological fracture and/or spinal cord compression) * Glucocorticoid allergy; * Immunodeficiency; * Severe infection; * Insulin dependent/independent Diabetes; * Having taken glucocorticoid in the past two weeks; * Not capable of swallowing tablets; * Without signed informed consent inform.
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What it tests

  • Prednisone
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Where

1 site
Shanghai Changzheng Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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