Post Marketing Surveillance Study of Actimmune in Patients With Severe, Malignant Osteopetrosis - Full Text View

Purpose

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

Genetics Home Reference related topics:

Melnick-Needles syndrome

ChemIDplus related topics:

Interferon alfa-2b Interferons Interferon gamma-1b

U.S. FDA Resources

Study Type:	Observational
Study Design:	Other, Retrospective

Official Title:	Post-Marketing Surveillance Study of Actimmune (Interferon Gamma-1b) in Patients With Severe Malignant Osteopetrosis

Further study details as provided by InterMune:

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	6
Study Start Date:	January 2002
Study Completion Date:	September 2005

Intervention Details:

as administered by physician

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Osteopetrosis patients receiving Actimmune therapy

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043329

Locations


United States, California
	InterMune, Inc.
	Brisbane, California, United States, 94005

Sponsors and Collaborators

InterMune

Investigators


Study Director:	Steven Porter, MD	InterMune

More Information

Study ID Numbers:	GIOS-003
First Received:	August 7, 2002
Last Updated:	October 30, 2007
ClinicalTrials.gov Identifier:	NCT00043329
Health Authority:	United States: Food and Drug Administration

Keywords provided by InterMune:

Registry

Actimmune

osteopetrosis

Study placed in the following topic categories:

Osteopetrosis

Interferon Type II

Musculoskeletal Diseases

Interferons

Bone Diseases, Developmental

Osteochondrodysplasias

Interferon Alfa-2b

Bone Diseases

Albers-Schonberg disease

Interferon-gamma, Recombinant

Additional relevant MeSH terms:

Anti-Infective Agents

Antineoplastic Agents

Therapeutic Uses

Antiviral Agents

Pharmacologic Actions

Osteosclerosis

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	InterMune
Information provided by:	InterMune
ClinicalTrials.gov Identifier:	NCT00043329