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 @ 4:28 AM
Ignite Modification Date:
2025-12-25 @ 4:28 AM
NCT ID:
NCT00638820
Eligibility Criteria:
Inclusion Criteria:
* Patients eligible for transplantation under this protocol will be \<45 years of age, and will be diagnosed with severe osteopetrosis. This will be defined as having the following manifestations of the disease.
* Bones that are uniformly markedly dense based on skeletal survey
* No history that would suggest autosomal dominant inheritance
* Evidence of hematologic changes that are attributed to the underlying disease, including the need for ongoing transfusions, OR
* the presence of progressive anemia or thrombocytopenia, OR a white blood cell differential with a predominance of immature forms and evidence of extramedullary hematopoiesis, OR
* persistence of serious infectious complications that are thought to be due to the abnormal architecture of the bone that are resistant to surgical and medical interventions.
Exclusion Criteria:
* Patients \>45 years of age
* Evidence of hepatic failure
* pulmonary dysfunction sufficient to substantially increase the risk of transplant
* Renal dysfunction with glomerular filtration rate (GFR) \<30% of predicted.
* Cardiac compromise sufficient to substantially increase the risk of transplantation
* Severe, stable neurologic impairment.
* Human immunodeficiency virus (HIV) positivity.
* Pregnant or lactating females
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
45 Years
Study:
NCT00638820
Study Brief:
Protocol Section:
NCT00638820