Post Marketing Surveillance Study of Actimmune in Patients With Severe, Malignant Osteopetrosis
Information source: InterMune
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteopetrosis
Intervention: Actimmune Registry (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: InterMune Official(s) and/or principal investigator(s):
Steven Porter, MD, Study Director, Affiliation: InterMune
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.
Clinical Details
Official title: Post-Marketing Surveillance Study of Actimmune (Interferon Gamma-1b) in Patients With Severe Malignant Osteopetrosis
Study design: Other, Retrospective
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 (ActimmuneŽ) 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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
InterMune, Inc., Brisbane, California 94005, United States
Additional Information
Starting date: January 2002
Ending date: September 2005
Last updated: October 30, 2007
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