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Gamma IFN in Idiopathic Pulmonary Fibrosis.

Phase 1
Conditions
Idiopathic Pulmonary Fibrosis.
Registration Number
RPCEC00000114
Lead Sponsor
Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
12
Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Overall rating (given by 3 categories of response: improved stability and progression. Considering the clinical course, progression of fibrosis and improvement of pulmonary ventilation), a month of starting treatment, at 3 and 6 months (end of treatment) as well as a year.
Secondary Outcome Measures
NameTimeMethod
Response time (defined as the time from the date of start of treatment until the date on which improvement is achieved). Measuring time: months 1, 3, 6 and 12 after starting treatment. Quality of life (defined in terms of indices of dyspnea and the need for oxygen consumption). Measuring time: months 1, 3, 6 and 12 after starting treatment. Adverse short and long term, including the formation of anti-interferon. Measuring time: months 1, 3, 6 and 12 after starting treatment.
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