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

Sponsor
InterMune (Industry)
Overall Status
Completed
CT.gov ID
NCT00043329
Collaborator
(none)
6
Enrollment
1
Location
44
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: Actimmune Registry

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.

Study Design

Study Type:
Observational
Actual Enrollment :
6 participants
Time Perspective:
Retrospective
Official Title:
Post-Marketing Surveillance Study of Actimmune (Interferon Gamma-1b) in Patients With Severe Malignant Osteopetrosis
Study Start Date :
Jan 1, 2002
Actual Study Completion Date :
Sep 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    • 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

    Locations

    Site City State Country Postal Code
    1 InterMune, Inc. Brisbane California United States 94005

    Sponsors and Collaborators

    • InterMune

    Investigators

    • Study Director: Steven Porter, MD, InterMune

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00043329
    Other Study ID Numbers:
    • GIOS-003
    First Posted:
    Aug 20, 2002
    Last Update Posted:
    Nov 1, 2007
    Last Verified:
    Oct 1, 2007
    Keywords provided by , ,
    Registry
    Actimmune
    osteopetrosis
    Additional relevant MeSH terms:
    Osteopetrosis
    Interferon-gamma

    Study Results

    No Results Posted as of Nov 1, 2007