Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT00004402
Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
* Biopsy and x-ray confirmed primary osteopetrosis
* Presence of anemia and/or cranial nerve compression
--Prior/Concurrent Therapy--
* Biologic therapy: No prior/concurrent bone marrow transplantation No prior interferon gamma No other investigational biologic agents
* Chemotherapy: No prior/concurrent chemotherapeutic agents for bone marrow transplantation
* Endocrine therapy: Prior/concurrent corticosteroid as supportive therapy allowed
* Radiotherapy: Not specified
* Surgery: At least 5 days since major surgery
* Other: Prior/concurrent calcitriol as supportive therapy allowed Prior/concurrent transfusion as supportive therapy allowed Prior/concurrent dietary therapy allowed
--Patient Characteristics--
* Age: 2 months to 10 years
* Performance status: Not specified
* Life expectancy: At least 6 months
* Hematopoietic: Not specified
* Hepatic: Bilirubin less than 2 mg/dL
* Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min
* Pulmonary: No uncorrected airway obstruction
* Other: No active infection requiring intravenous antibiotics No known seizure disorder not related to hypocalcemia No uncorrected hydrocephalus No MRI evidence of cerebral atrophy Must maintain or gain body weight No sleep apnea No thrombocytopenia No massive splenomegaly
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
10 Years
Study:
NCT00004402
Study Brief:
Protocol Section:
NCT00004402