se of gamma interferon in patients with idiopathic pulmonary fibrosis.

Center for Genetic Engineering and Biotechnology (CIGB), in Havana.0 个研究点目标入组 12 人开始时间: 2011年5月17日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment

•1) In the case of patients aged between 18 and 34 (both inclusive) should have clinical diagnostic and functional tests for high-resolution helical computed tomography and bronchoscopy with transbronchial biopsy (or video-assisted thoracic surgery). 2) In the case of patients aged between 35 and 70 (both inclusive) have made the diagnosis of idiopathic pulmonary fibrosis probable or definite by clinical, functional tests and through the high-resolution helical computed tomography. 3) General condition index according to WHO under 3 or Karnofsky index greater than 50. 4) Values ??of WBC = 4 x 109 / L and platelets = 100 000 uL. 5) hemoglobin above 10 g / L. 6) Patients with acceptable renal function (serum creatinine <132 umol / L, proteinuria <2 g / L). 7) acceptable hepatic function (serum bilirubin <18.3 umol / L, alkaline phosphatase <90 IU, prothrombin time <1.3 times control) 8) Patients who have not been treated with glucocorticoids, or who have not obtained a favorable response to corticosteroids measured by lung function test. 9) Patients with a forced vital capacity between 85% and 41% at diagnosis or following continuous or repeated treatment with corticosteroids for 6 months. 10) patients without immunosuppressive treatment in the last 3 months. 11) Women of childbearing age who used no hormonal contraceptive method. 12) Willingness of the patient by signing written consent.

•1) Another disease that compromises the patient's life. 2) Patients with a history of exposure to drugs or inorganic agents known to cause pulmonary fibrosis and other connective tissue disease or other lung diseases that cause pulmonary fibrosis. 3) Patients with end-stage pulmonary fibrosis identified by a forced vital capacity less than 40% of predicted normal. 4) Pregnancy and lactation. 5) Hypersensitivity to interferon or other preparations used in the study. 6) severe psychiatric disorder or other constraints that prevent the patient's consent. 7) Multiple sclerosis and other autoimmune diseases. 8) and hypertensive diabetic patients with moderate or severe.

发起方

Center for Genetic Engineering and Biotechnology (CIGB), in Havana.