NCT06078969 Oral Prednisone in Treating LCH of Bone in Childhood and Adolescence
| NCT ID | NCT06078969 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Changzheng Hospital |
| Condition | Langerhans Cell Histiocytosis of Bone |
| Study Type | INTERVENTIONAL |
| Enrollment | 118 participants |
| Start Date | 2023-11-04 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 118 participants in total. It began in 2023-11-04 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 \[Control group\].
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT06078969 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 17 Years, studying Langerhans Cell Histiocytosis of Bone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06078969 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06078969 currently recruiting?
Yes, NCT06078969 is actively recruiting participants. Visit ClinicalTrials.gov or contact Shanghai Changzheng Hospital to inquire about joining.
Where is the NCT06078969 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06078969 clinical trial?
NCT06078969 is sponsored by Shanghai Changzheng Hospital. The trial plans to enroll 118 participants.