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Sponsored by: |
InterMune |
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Information provided by: | InterMune |
ClinicalTrials.gov Identifier: | NCT00043329 |
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.
Condition | Intervention | Phase |
---|---|---|
Osteopetrosis |
Drug: Actimmune Registry |
Phase IV |
Study Type: | Observational |
Study Design: | Retrospective |
Official Title: | Post-Marketing Surveillance Study of Actimmune (Interferon Gamma-1b) in Patients With Severe Malignant Osteopetrosis |
Enrollment: | 6 |
Study Start Date: | January 2002 |
Study Completion Date: | September 2005 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Osteopetrosis patients receiving Actimmune therapy
Study ID Numbers: | GIOS-003 |
Study First Received: | August 7, 2002 |
Last Updated: | October 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00043329 |
Health Authority: | United States: Food and Drug Administration |
Registry Actimmune osteopetrosis |
Osteopetrosis Interferon Type II Musculoskeletal Diseases Interferons Bone Diseases, Developmental |
Osteochondrodysplasias Bone Diseases Albers-Schonberg disease Interferon-gamma, Recombinant |
Anti-Infective Agents Antineoplastic Agents Therapeutic Uses |
Antiviral Agents Pharmacologic Actions Osteosclerosis |