Overview

Phase III Randomized Study of Interferon Gamma in Children With Severe, Congenital Osteopetrosis

Status:
Completed
Trial end date:
2000-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
FDA Office of Orphan Products Development
Collaborator:
Medical University of South Carolina
Treatments:
Calcitriol
Interferon-gamma
Interferons