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临床试验/NL-OMON30290
NL-OMON30290已完成3 期

Mycophenolate sodium (Myfortic) in the Treatment of Uveitis: a Pilot Study. - Myfortic in Uveitis

Academisch Medisch Centrum0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
24

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • patients with steroid refractory non-infectious uveitis

排除标准

  • 1. fundus not visualizable opacities.
  • 2. requiring ocular surgery < 3 months of treatment, or surgery in the prior 3 months.
  • 3. pregnancy , nursing, or planning pregnancy within 6 months after screening (i.e., approximately 6 weeks following last treatment).
  • 4. Use of any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer.
  • 5. History of systemic immunosuppressive therapy, other than steroids for ocular disease.
  • 6. Creatinine clearance of < 20ml/min.
  • 7. Patients with known hypersensitivity to prednisone, cyclosporine, Myfortic® or to drugs with similar chemical structures.
  • 8. Patients with any clinically significant infection.
  • 9. Documented HIV infection.
  • 10. Patients with active TB or evidence of latent TB.
  • 11. Patients with opportunistic infections, including but not limited to evidence of active cytomegalovirus, active Pneumocystis carinii, Aspergillosis, Histoplasmosis or atypical mycobacterium infection, etc, within the previous 6 months.
  • 12. Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
  • 13. Presence of a transplanted organ (with the exception of a corneal transplant 3 months prior to screening).
  • 14. Malignancy within the past 5 years (except for treated squamous or basal cell carcinoma of the skin without evidence of recurrence).
  • 15. History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly.
  • 16. Known recent substance abuse (drugs or alcohol).
  • 17. Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling during the study period.
  • 18. Recent live vaccinations
  • 19. Lues infection or serology

研究者

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