Post Marketing Surveillance Study of Actimmune in Patients With Severe, Malignant Osteopetrosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00043329|
Recruitment Status : Completed
First Posted : August 20, 2002
Last Update Posted : November 1, 2007
|Condition or disease||Intervention/treatment|
|Osteopetrosis||Drug: Actimmune Registry|
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.
|Study Type :||Observational|
|Actual Enrollment :||6 participants|
|Official Title:||Post-Marketing Surveillance Study of Actimmune (Interferon Gamma-1b) in Patients With Severe Malignant Osteopetrosis|
|Study Start Date :||January 2002|
|Actual Study Completion Date :||September 2005|
Drug: Actimmune Registry
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00043329
|United States, California|
|Brisbane, California, United States, 94005|
|Study Director:||Steven Porter, MD||InterMune|