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Generated: February 19, 2019

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CLINICAL TRIALS PROFILE FOR AZATHIOPRINE

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Clinical Trials for Azathioprine

Trial ID Title Status Sponsor Phase Summary
NCT00000524 Myocarditis Treatment Trial Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 To determine whether immunosuppressive treatment improved cardiac function in patients with biopsy-proven myocarditis.
NCT00000524 Myocarditis Treatment Trial Completed University of Utah Phase 2 To determine whether immunosuppressive treatment improved cardiac function in patients with biopsy-proven myocarditis.
NCT00000936 A Study To Test An Anti-Rejection Therapy After Kidney Transplantation Terminated National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 Kidney transplantation is often successful. However, despite aggressive anti-rejection drug therapy, some patients will reject their new kidney. This study is designed to test two anti-rejection approaches. Two medications in this study are currently used in children, but there is no information regarding which drug is safer or more effective. Survival rates in renal transplantation are unacceptably low. Therefore, there is a need for an improved post-transplant treatment, such as the induction therapy used in this study.
NCT00001737 Cyclosporin Implant to Treat Uveitis Completed National Eye Institute (NEI) Phase 1 This study will evaluate the safety and effectiveness of a sustained-release cyclosporin implant to treat uveitis, a sight-threatening eye inflammation caused by an immune system abnormality. Previous studies in humans have shown that, taken by mouth, the drug cyclosporin is effective in treating chronic uveitis. Uveitis may require long-term treatment with potent immune-suppressing drugs, such as cyclosporin, cyclophosphamide, methotrexate, azathioprine or steroids. Taken systemically (by mouth or injection), however, these drugs can do serious damage to the kidneys, liver or lungs, and can raise blood pressure and lower blood cell counts. Because of this, some patients cannot or will not use these medicines. This small pilot study will evaluate the safety, and to some extent effectiveness, of cyclosporin delivered directly into the eye, to try to prevent harmful side effects. In animal studies, sustained-release cyclosporin implants did not cause the severe side effects seen with systemic use of the drug. Some animals developed opacity of the lens and slowed retinal responses, both of which reversed when the drug was stopped. Earlier animal studies of cyclosporin injected directly into the eye reduced inflammation that had been produced experimentally. Patients with uveitis who have active inflammation and poor vision are eligible to participate in this study. Patients will be randomly assigned to one of two treatment groups. One group will receive a 1-mg implant that releases 0.8 micrograms of drug each day; the second group will receive a 2-mg implant that delivers 1.4 micrograms of drug a day. Before surgery, patients will have a medical history, basic physical examination, and complete eye examination, including special tests called electroretinogram and fluorescein angiography. An electroretinogram measures the electrical responses generated in the retina in the back of the eye. Fluorescein angiography uses a special camera to photograph the retina, showing the condition of the blood vessels in the eye. The surgical procedure to place the implant takes about 1.5 hours and may be done under either local or general anesthesia. Patients will stay in the hospital overnight. After discharge from the hospital, they will return for follow-up visits 1 and 2 weeks after surgery, then once a month for 6 months, and then every 3 months until the implant is depleted of drug or removed. During these follow-up visits, eye examinations will be repeated to evaluate the effects of the implant on the eye. Repeat blood tests will measure the amount of cyclosporin in the blood and the drug's effect on the kidneys. When the implant runs out of drug (between 2 and 3 years), it may be removed or left in place.
NCT00001764 Mycophenolate Mofetil to Treat Wegener's Granulomatosis and Related Vascular Inflammatory Conditions Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 This study will examine the safety and effectiveness of the drug mycophenolate mofetil (MPM) in treating Wegener's granulomatosis and related inflammatory vessel diseases. Blood vessel inflammation in these patients may involve different parts of the body, including the brain, nerves, eyes, sinuses, lungs, kidneys, intestinal tract, skin, joints, heart, and other sites. The more severe the involvement, the more likely the disease will be life-threatening. Standard treatment consists of combination drug therapy with prednisone and a cytotoxic agent-usually cyclophosphamide or methotrexate. However, some patients in whom this treatment is initially successful have a disease relapse; other patients cannot take the medications because of other health problems or because of severe side effects of the drugs. MPM is approved by the Food and Drug Administration to prevent kidney transplant rejection. It is chemically similar to another cytotoxic drug called azathioprine, which has been beneficial in maintaining remission in patients with Wegener's granulomatosis who have been treated successfully with cyclophosphamide. Because MPM is more effective than azathioprine in preventing organ rejection, it may also prove beneficial as a second-line treatment for Wegener's granulomatosis. Patients with Wegener's granulomatosis or related inflammatory vessel diseases who have had a relapse following treatment with cyclophosphamide and methotrexate or who cannot take one or both of these drugs may be eligible for this study. Only patients who have been treated at NIH in the methotrexate protocol or the cyclophosphamide switching to methotrexate protocol, or who have received the exact same treatment from their own physician may participate. Participants will have a complete medical evaluation including laboratory studies. Consultations, X-rays and biopsies of affected organs may also be done if indicated for diagnosis or treatment. Patients with active disease will be given MPM and prednisone, both in tablet form. Patients with inactive disease will receive only prednisone if they are already taking it. In both cases, the prednisone will be reduced gradually and discontinued if the disease improves significantly. MPM therapy will continue for at least 2 years. If after 2 years the disease remains in remission, the MPM dose will be gradually reduced and then stopped. If active disease recurs while on MPM therapy, the treatment plan will likely be changed. The new regimen will be determined by the severity of disease, other medical conditions, and history of side effects to previous medications. Patients will be followed at the NIH clinic every month for the first 3 months on MPM and then every 3 months for another 18 months. Those whose disease has remained in remission and have stopped all medications will then be followed every 6 months for 4 visits. The follow-up visits will include a physical examination, blood draws, and, if needed, X-rays. Visits may be scheduled more frequently if medically indicated.
NCT00001863 Leflunomide to Treat Uveitis Completed National Eye Institute (NEI) Phase 2 This study will investigate the safety and effectiveness of the drug Leflunomide to treat uveitis-an inflammation of the eye caused by an immune system abnormality. Leflunomide suppresses immune system activity and has been shown to control autoimmune diseases, such as arthritis (joint inflammation), in animals. It has also improved symptoms in patients with rheumatoid arthritis, and the Food and Drug Administration has approved it for treating patients with this disease. Eye and joint inflammation may have similar causes, and medicines for arthritis often help patients with eye inflammation. This study will examine whether Leflunomide can help patients with uveitis. Patients with uveitis who are not responding well to steroid treatment and patients who have side effects from other medicines used to treat uveitis (such as cyclosporine, cyclophosphamide, methotrexate or azathioprine) or have refused treatment because of possible side effects of these medicines may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood test and eye examination. The eye exam includes a check of vision and eye pressure, examination of the back of the eye (retina) with an ophthalmoscope and the front of the eye with a microscope. They will also undergo a procedure called fluorescein angiography to look at the blood vessels of the eye. A dye called sodium fluorescein is injected into the bloodstream through a vein. After the dye reaches the blood vessels of the eye, photographs are taken of the retina. Study participants will be divided into two groups. One group will take 100 milligrams of Leflunomide once a day for 3 days and then 20 milligrams once a day for 6 months. The other group will take a placebo-a pill that looks like the Leflunomide pill but does not contain the medicine. All patients in both groups will also take prednisone. Patients will have follow-up examinations at weeks 1, 4, 8, 12, 16, and 24 (6 months) of the study. Each follow-up visit will include a repeat of the screening exams and an evaluation of side effects or discomfort from the medicine. Those who do well and want to continue their assigned treatment after 6 months can continue that treatment for another 6 months and will have follow-up exams at months 9 and 12.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Azathioprine

Condition Name

Condition Name for Azathioprine
Intervention Trials
Crohn's Disease 26
Ulcerative Colitis 17
Lupus Nephritis 15
Crohn Disease 10
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Condition MeSH

Condition MeSH for Azathioprine
Intervention Trials
Crohn Disease 37
Colitis, Ulcerative 22
Colitis 22
Ulcer 20
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Clinical Trial Locations for Azathioprine

Trials by Country

Trials by Country for Azathioprine
Location Trials
United States 390
Canada 44
France 35
Italy 28
Germany 27
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Trials by US State

Trials by US State for Azathioprine
Location Trials
California 28
New York 25
North Carolina 20
Pennsylvania 20
Illinois 18
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Clinical Trial Progress for Azathioprine

Clinical Trial Phase

Clinical Trial Phase for Azathioprine
Clinical Trial Phase Trials
Phase 4 59
Phase 3 67
Phase 2/Phase 3 11
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Clinical Trial Status

Clinical Trial Status for Azathioprine
Clinical Trial Phase Trials
Completed 105
Recruiting 50
Terminated 28
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Clinical Trial Sponsors for Azathioprine

Sponsor Name

Sponsor Name for Azathioprine
Sponsor Trials
Assistance Publique - Hôpitaux de Paris 14
National Institute of Allergy and Infectious Diseases (NIAID) 11
Hoffmann-La Roche 9
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Sponsor Type

Sponsor Type for Azathioprine
Sponsor Trials
Other 316
Industry 100
NIH 32
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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Moodys
QuintilesIMS
Johnson and Johnson
Dow
US Army
Daiichi Sankyo
Chubb
US Department of Justice

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