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Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients with Wegener's Granulomatosis Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients with Wegener's Granulomatosis conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients with Wegener's Granulomatosis Clinical research trials and Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients with Wegener's Granulomatosis medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients with Wegener's Granulomatosis. Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients with Wegener's Granulomatosis Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients with Wegener's Granulomatosis clinical trial. Test subjects typically obtain the finest healthcare available for their Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients with Wegener's Granulomatosis condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients with Wegener's Granulomatosis  Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients with Wegener's Granulomatosis
Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients with Wegener's Granulomatosis
For Condition: Vasculitis,Wegener's Granulomatosis
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to assess the safety, tolerance, and immunologic effects of interleukin-10 (IL-10), in patients with Wegener's granulomatosis. A secondary objective is to determine if IL-10 demonstrates sufficient anti-inflammatory activity in the treatment of Wegener's granulomatosis to warrant further study in a larger trial. In this study, IL-10 will be given either alone or in combination with standard therapeutic agents, usually consisting of cyclophosphamide, methotrexate, and/or prednisone. Patients will be eligible to receive IL-10 when there is evidence of active disease. IL-10 will be administered by subcutaneous injection at a dose of 4 µ (Micro)g/kg/day for 28 days.
Details: The purpose of the study is to assess the safety, tolerance, and immunologic effects of interleukin-10 (IL-10), in patients with Wegener's granulomatosis. A secondary objective is to determine if IL-10 demonstrates sufficient anti-inflammatory activity in the treatment of Wegener's granulomatosis to warrant further study in a larger trial. In this study, IL-10 will be given either alone or in combination with standard therapeutic agents, usually consisting of cyclophosphamide, methotrexate, and/or prednisone. Patients will be eligible to receive IL-10 when there is evidence of active disease. IL-10 will be administered by subcutaneous injection at a dose of 4 µ (Micro)g/kg/day for 28 days.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Diagnosis of Wegener's granulomatosis based on clinical characteristics and histopathological and/or angiographic evidence of vasculitis or the presence of glomerulonephritis and a positive assay for anti-neutrophil cytoplasmic autoantibodies (ANCA). Age between 18 to 65 years. No change in immunosuppressive drug therapy during the prior 4 weeks and one of the following: Persistent disease activity ("Vasculitis Activity Index" score of greater than or equal to 3) despite optimal therapy; Persistent or recurrent disease activity in a patient who cannot tolerate optimal therapy; Patients not on maximal immunosuppressive therapy but with persistent or recurrent disease activity that is not, in the judgment of investigators, immediately threatening the function of a major organ system; No evidence of active infection. Patients may not be pregnant or nursing infants. Fertile women must have a negative pregnancy test within one week prior to study entry and all participants must be using effective means of birth control. Serum creatinine is less than 3.5 mg/dL. Hemocytopenia (platelet count is greater than 100,000/mm(3), leukocyte count is greater than 3,500/mm(s), hemoglobin is greater than 9 mg/dL). Liver function test abnormalities is less than 3x upper limits of normal (either serum GOT, GPT, alkaline phosphatase, and/or bilirubin). Patients cannot be anti-HIV, anti-HCV, or anti-Hepatitis B surface antigen (HBsAG) positive. Weight greater less than 104 Kg (because of SCH 52000 concentration and volume limitations for subcutaneous injection). No treatment with any investigational drug within 30 days. No pre-existing malignancy. No known allergy to E. coli protein or IL-10. No history of psychiatric illness that in the opinion of the principal investigator would preclude entrance into the study.
Total Enrollment: 15
Location and Contact Information:
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 980059; 98-I-0059
Study Start Date: February 2, 1998
Record last reviewed: January 4, 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001761
Other Vasculitis Studies:
1. Steroids and Methotrexate to Treat Systemic Vasculitis
2. Cyclophosphamide and Prednisone Followed by Methotrexate To Treat Vasculitides
3. Inflammatory Responses in Normal Volunteers and Patients with Abnormal Immune Responses
4. Treatment of Wegener's Granulomatosis with Cyclophosphamide
5. Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients with Wegener's Granulomatosis
Related Studies:
Other Vasculitis Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients with Wegener's Granulomatosis
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