Actively Recruiting
Oral Prednisone in Treating LCH of Bone in Childhood and Adolescence
Led by Shanghai Changzheng Hospital · Updated on 2024-02-01
118
Participants Needed
1
Research Sites
203 weeks
Total Duration
On this page
Sponsors
S
Shanghai Changzheng Hospital
Lead Sponsor
F
First Affiliated Hospital of Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 \[Control group\].
CONDITIONS
Official Title
Oral Prednisone in Treating LCH of Bone in Childhood and Adolescence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathological diagnosis of Langerhans cell histiocytosis (LCH) of bone
- Single-system involvement limited to the skeletal system
- No need for surgical intervention
- Ability to swallow tablets
- Signed informed consent form obtained
You will not qualify if you...
- Multi-system involvement affecting two or more systems including bone, liver, spleen, blood, or central nervous system
- Need for surgical intervention such as pathological fracture or spinal cord compression
- Allergy to glucocorticoids
- Immunodeficiency
- Severe infection
- Diabetes requiring insulin or not
- Use of glucocorticoids within the past two weeks
- Unable to swallow tablets
- Lack of signed informed consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 200003
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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