Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043329
Status:
COMPLETED
Last Update Posted:
2007-11-01
First Post:
2002-08-07
Brief Title:
Post Marketing Surveillance Study of Actimmune in Patients With Severe Malignant Osteopetrosis
Sponsor:
InterMune
Organization:
InterMune
Study Overview
Official Title:
Post-Marketing Surveillance Study of Actimmune Interferon Gamma-1b in Patients With Severe Malignant Osteopetrosis
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 examinedInterferon gamma is a substance that the body makes naturally
Detailed Description:
It is made by white blood cells and appears to be involved in regulating the bodys 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 2000 patients in diseases such as CGD osteopetrosis atopic dermatitis pulmonary fibrosis atypical mycobacteria and various cancers
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 2000 patients in diseases such as CGD osteopetrosis atopic dermatitis pulmonary fibrosis atypical mycobacteria and various cancers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None