Gamma IFN in Idiopathic Pulmonary Fibrosis.

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000114
• Date of registration: 17/05/2011
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
• Public title: Gamma IFN in Idiopathic Pulmonary Fibrosis.
• Scientific title: Use of gamma interferon in patients with idiopathic pulmonary fibrosis.
• Date of first enrolment: 24/10/2000
• Target sample size: 12
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000114-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Dr. Lidia González Méndez
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

• Name: Dr. Lidia González Méndez
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

Key inclusion & exclusion criteria

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.

Age minimum: 18 years
Age maximum: 70 years
Gender: Both

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis.

Intervention(s)

Manage 1 million IU of gamma IFN (2 vials) 3 times a week intramuscularly for 6 months (24 weeks). Jointly administered prednisone (20 mg tablets), 3 tablets (60 mg) daily by mouth for the first 2 months of treatment, follow daily the 3rd month with 2 1/2 tablets (50 mg) daily, the 4th month with 2 tablets (40mg), the 5th month with 1 1/2 tablets (30 mg) and the 6th month with 1 tablet (20 mg). Will continue with 1/2 tablet (10 mg) daily until 9 months, followed by 1/4 tablet (5 mg) daily until the year.

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

IG/IG/FPI/0001

Source(s) of Monetary Support

HeberBiotec S.A. Ministry of Public Health, CUBA.

Secondary Sponsor(s)

Ministry of Public Health, CUBA.