Overview

Post Marketing Surveillance Study of Actimmune in Patients With Severe, Malignant Osteopetrosis

Status:
Completed
Trial end date:
2005-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to establish a registry of all children with severe, malignant osteopetrosis who are treated with Actimmune (IFN-g 1b or Interferon gamma-1b) to monitor the effects of IFN-g 1b on preventing progression of this disease and to follow the safety of patients receiving it on a long-term basis. In addition, evaluation of the possible effect of Actimmune therapy on the humoral response to normal childhood vaccinations in this same patient population will be examined.Interferon gamma is a substance that the body makes naturally.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
InterMune
Treatments:
Interferon-gamma
Criteria
- Male or female

- Diagnosis of severe, malignant osteopetrosis

- Currently receiving or planning to initiate therapy with Actimmune (Interferon
gamma-1b)

- Willing to attend follow-up appointments every 6 months following enrollment into the
study, if clinically indicated