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