drugset / Trial / NCT00004402
Phase III Randomized Study of Interferon Gamma in Children With Severe, Congenital Osteopetrosis
Phase 3
Completed
30 enrolled
FDA Office of Orphan Products Development
Medical University of South Carolina · collab
Treatment
Summary
OBJECTIVES: I. Compare the rate of treatment failure in osteopetrosis patients receiving interferon gamma in combination with calcitriol to the rate of treatment failure in patients receiving calcitriol alone. II. Compare the number of adverse events or clinical manifestations of disease progression occurring in these patients. III. Assess the effects of interferon gamma on hematopoiesis, cranial nerve function, and rate of infection in these patients.
Timeline
- Start
- 1999-11
- Primary completion
- —
- Completion
- 2000-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | interferon gamma | Protein / enzyme biologic | — | Subcutaneous |
| Background | Calcitriol | Small molecule | — | — |