Gamma IFN in Idiopathic Pulmonary Fibrosis.

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Use of gamma interferon in patients with idiopathic pulmonary fibrosis.

Secondary indentifying numbers:

IG/IG/FPI/0001

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB).

Source(s) of monetary or material support:

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

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

04/08/2000

Reference number:

93/70091

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Isis Cayon Escobar MD

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Clinical - Surgical Hospital "Hermanos Ameijeiras", Carlos Gassiot Nuño MD.

Research ethics committees:

“Benéfico-Jurídico” Hospital, April 14, 2000. Clinical - Surgical Hospital "Hermanos Ameijeiras", May 5, 2000.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

24/10/2000

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

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.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

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.

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

70 years

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Dr. Lidia

Last Name:

González Méndez

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

Email :

lidia.gonzalez@cigb.edu.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Dr. Lidia

Last Name:

González Méndez

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

Email :

lidia.gonzalez@cigb.edu.cu [2]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000114

Date of Registration in Primary Registry:

2011-05-17

Record Verification Date:

2011-05-07 20:00

Link to the spanish version:

Click here [3]