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

This study has been completed.
Sponsor:
Information provided by:
InterMune
ClinicalTrials.gov Identifier:
NCT00043329
First received: August 7, 2002
Last updated: October 30, 2007
Last verified: October 2007

August 7, 2002
October 30, 2007
January 2002
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Complete list of historical versions of study NCT00043329 on ClinicalTrials.gov Archive Site
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Post Marketing Surveillance Study of Actimmune in Patients With Severe, Malignant Osteopetrosis
Post-Marketing Surveillance Study of Actimmune (Interferon Gamma-1b) in Patients With Severe Malignant Osteopetrosis

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.

It is made by white blood cells and appears to be involved in regulating the body's ability to fight off infection. Actimmune is a synthetic form of Interferon gamma which is similar to that normally made by white blood cells.

IFN-g 1b (Actimmune®) is currently approved by the United States Food and Drug Administration (FDA) for the treatment of patients with chronic granulomatous disease (CGD) to reduce the frequency and severity of serious infections. It is also approved in patients with severe, malignant osteopetrosis to delay the time to disease progression. In research trials, IFN-g 1b has been given to over 2,000 patients in diseases such as CGD, osteopetrosis, atopic dermatitis, pulmonary fibrosis, atypical mycobacteria and various cancers.

Observational
Time Perspective: Retrospective
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Non-Probability Sample

Osteopetrosis patients receiving Actimmune therapy

Osteopetrosis
Drug: Actimmune Registry
as administered by physician
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
September 2005
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  • 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
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00043329
GIOS-003
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InterMune
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Study Director: Steven Porter, MD InterMune
InterMune
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP