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Phase III Randomized Study of Interferon Gamma in Children With Severe, Congenital Osteopetrosis Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Phase III Randomized Study of Interferon Gamma in Children With Severe, Congenital Osteopetrosis conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Phase III Randomized Study of Interferon Gamma in Children With Severe, Congenital Osteopetrosis Clinical research trials and Phase III Randomized Study of Interferon Gamma in Children With Severe, Congenital Osteopetrosis health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Phase III Randomized Study of Interferon Gamma in Children With Severe, Congenital Osteopetrosis. Phase III Randomized Study of Interferon Gamma in Children With Severe, Congenital Osteopetrosis Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Phase III Randomized Study of Interferon Gamma in Children With Severe, Congenital Osteopetrosis clinical trial. Human subjects often get the best healthcare possible for their Phase III Randomized Study of Interferon Gamma in Children With Severe, Congenital Osteopetrosis condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase III Randomized Study of Interferon Gamma in Children With Severe, Congenital Osteopetrosis  Phase III Randomized Study of Interferon Gamma in Children With Severe, Congenital Osteopetrosis
Phase III Randomized Study of Interferon Gamma in Children With Severe, Congenital Osteopetrosis
For Condition: Osteopetrosis
Status: Completed
Sponsor(s): FDA Office of Orphan Products Development , Medical University of South Carolina
Synopsis: OBJECTIVES: I. Compare the rate of treatment failure in osteopetrosis patients receiving interferon gamma in combination with calcitriol to the rate of treatment failure in patients receiving calcitriol alone. II. Compare the number of adverse events or clinical manifestations of disease progression occurring in these patients. III. Assess the effects of interferon gamma on hematopoiesis, cranial nerve function, and rate of infection in these patients.
Details: PROTOCOL OUTLINE: This is a randomized, placebo controlled, open label study. Patients are randomized to one of two arms (interferon gamma in combination with calcitriol or calcitriol alone). Arm I: Patients receive calcitriol once daily. Interferon gamma is administered by subcutaneous injection three times a week. Arm II: Patients receive calcitriol once daily. Patients may continue treatment in the absence of toxicity and disease progression. If disease progression is diagnosed in the control group, patients will then receive interferon gamma in combination with calcitriol. Patients are followed every 4 weeks.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /10 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Biopsy and x-ray confirmed primary osteopetrosis - Presence of anemia and/or cranial nerve compression --Prior/Concurrent Therapy-- - Biologic therapy: No prior/concurrent bone marrow transplantation No prior interferon gamma No other investigational biologic agents - Chemotherapy: No prior/concurrent chemotherapeutic agents for bone marrow transplantation - Endocrine therapy: Prior/concurrent corticosteroid as supportive therapy allowed - Radiotherapy: Not specified - Surgery: At least 5 days since major surgery - Other: Prior/concurrent calcitriol as supportive therapy allowed Prior/concurrent transfusion as supportive therapy allowed Prior/concurrent dietary therapy allowed --Patient Characteristics-- - Age: 2 months to 10 years - Performance status: Not specified - Life expectancy: At least 6 months - Hematopoietic: Not specified - Hepatic: Bilirubin less than 2 mg/dL - Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min - Pulmonary: No uncorrected airway obstruction - Other: No active infection requiring intravenous antibiotics No known seizure disorder not related to hypocalcemia No uncorrected hydrocephalus No MRI evidence of cerebral atrophy Must maintain or gain body weight No sleep apnea No thrombocytopenia No massive splenomegaly
Total Enrollment: 30
Location and Contact Information:
Overall Study Official:
L.Key, Study Chair, Medical University of South Carolina
Additional Information:
Study ID Numbers: 199/13284; MUSC-FDR000768
Study Start Date: November 1999
Record last reviewed: January 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004402
Other Osteopetrosis Studies:
1. Post marketing surveillance study of Actimmune in patients with severe, malignant osteopetrosis.
2. Phase III Randomized Study of Interferon Gamma in Children With Severe, Congenital Osteopetrosis
3. Study of Unrelated Allogeneic Bone Marrow Transplantation in Patients With Benign Congenital Bone Marrow Failure Disorders
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Phase III Randomized Study of Interferon Gamma in Children With Severe, Congenital Osteopetrosis
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