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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00043329
First Posted: August 20, 2002
Last Update Posted: November 1, 2007
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.
Information provided by:
InterMune
  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 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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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
Information from the National Library of Medicine

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


Locations
United States, California
InterMune, Inc.
Brisbane, California, United States, 94005
Sponsors and Collaborators
InterMune
Investigators
Study Director: Steven Porter, MD InterMune
  More Information

ClinicalTrials.gov Identifier: NCT00043329     History of Changes
Other Study ID Numbers: GIOS-003
First Submitted: August 7, 2002
First Posted: August 20, 2002
Last Update Posted: November 1, 2007
Last Verified: October 2007

Keywords provided by InterMune:
Registry
Actimmune
osteopetrosis

Additional relevant MeSH terms:
Osteopetrosis
Osteosclerosis
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Interferon-gamma
Antiviral Agents
Anti-Infective Agents