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

This study has been completed.
Information provided by:
InterMune Identifier:
First received: August 7, 2002
Last updated: October 30, 2007
Last verified: October 2007
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 4

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Post-Marketing Surveillance Study of Actimmune (Interferon Gamma-1b) in Patients With Severe Malignant Osteopetrosis

Resource links provided by NLM:

Further study details as provided by InterMune:

Enrollment: 6
Study Start Date: January 2002
Study Completion Date: September 2005
Intervention Details:
    Drug: Actimmune Registry
    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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Osteopetrosis patients receiving Actimmune therapy
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00043329

United States, California
InterMune, Inc.
Brisbane, California, United States, 94005
Sponsors and Collaborators
Study Director: Steven Porter, MD InterMune
  More Information Identifier: NCT00043329     History of Changes
Other Study ID Numbers: GIOS-003
Study First Received: August 7, 2002
Last Updated: October 30, 2007

Keywords provided by InterMune:

Additional relevant MeSH terms:
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Antiviral Agents
Anti-Infective Agents processed this record on September 21, 2017