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Post marketing surveillance study of Actimmune in patients with severe, malignant osteopetrosis. Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Post marketing surveillance study of Actimmune in patients with severe, malignant osteopetrosis. conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Post marketing surveillance study of Actimmune in patients with severe, malignant osteopetrosis. Clinical research trials and Post marketing surveillance study of Actimmune in patients with severe, malignant osteopetrosis. medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Post marketing surveillance study of Actimmune in patients with severe, malignant osteopetrosis.. Post marketing surveillance study of Actimmune in patients with severe, malignant osteopetrosis. Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Post marketing surveillance study of Actimmune in patients with severe, malignant osteopetrosis. clinical trial. Subjects often receive the most expert healthcare possible for their Post marketing surveillance study of Actimmune in patients with severe, malignant osteopetrosis. condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Post marketing surveillance study of Actimmune in patients with severe, malignant osteopetrosis.  Post marketing surveillance study of Actimmune in patients with severe, malignant osteopetrosis.
Post marketing surveillance study of Actimmune in patients with severe, malignant osteopetrosis.
For Condition: Osteopetrosis
Status: Recruiting
Sponsor(s): InterMune ,
Synopsis: 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.
Details: 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:
Study Type: Observational, Natural History, Longitudinal, Defined Population, Prospective Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
NCGS Laboratories, Inc. *Recruiting*
, ,
Recruiting Project Manager 843-402-9505
Additional Information:
Study ID Numbers: GIOS-003;
Study Start Date: January 2002
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043329
Other Osteopetrosis Studies:
1. Phase III Randomized Study of Interferon Gamma in Children With Severe, Congenital Osteopetrosis
2. Study of Unrelated Allogeneic Bone Marrow Transplantation in Patients With Benign Congenital Bone Marrow Failure Disorders
3. Post marketing surveillance study of Actimmune in patients with severe, malignant osteopetrosis.
Related Studies:
Other Osteopetrosis Clinical Trials
Other Clinical Trials
Other Clinical Trials
Post marketing surveillance study of Actimmune in patients with severe, malignant osteopetrosis.
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