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

This study has been completed.
Sponsor:
Information provided by:
InterMune
ClinicalTrials.gov Identifier:
NCT00043329
First received: August 7, 2002
Last updated: October 30, 2007
Last verified: October 2007
History of Changes
  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:

U.S. FDA Resources

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

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

No publications provided

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

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013