Idiopathic Pulmonary Fibrosis (IPF)
Conditions
Interventions
Trade Name: Immukin
Product Name: Interferon gamma-1b
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Sub
Sponsors
InterMune
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study will be conducted, following their written informed consent, in patients of both sexes, aged between 40 and 79 years, inclusive, with clinical and radiographic diagnosis of IPF without evidence or suspicion of an alternative diagnosis that may contribute to the patient’s interstitial lung disease, and with evidence of IPF disease progression. In addition, patients must have FVC>55% e DLCO>35% at the screening visit. Patients must be able to understand the importance to adhere to the study treatment and the study protocol, including the concomitant medication restrictions throughout the study period Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -patients not able to comply with the instructions received from the Investigator -patients with any of the diseases and symptoms listed in the exclusion criteria reported in protocol no. GIPF-007 (items 2-20 re disease-related exclusions, medical exclusions and abnormal laboratory results) -pregnant or lactating women. Females of childbearing potential are required to have a negative serum pregnancy test before starting treatment and must agree to practice abstinence or prevent pregnancy by at least a barrier method for the entire duration of the study -patients who have had prior treatment with IFN-g 1b, beta interferon or other interferons -patients who have had treatment with other investigational drugs for any indication within 28 days of the screening visit -patients who have had treatment within 28 days of the screening visit with other investigational therapy for IPF, any cytotoxic/immunosuppressive agent (except corticosteroids), any cytokine modulator, any therapy targeted to treat IPF. - patients who have received therapy with prednisone (or equivalent compounds, with dose adjusted for potency) doses higher than 0.125 mg/kg ideal body weight (IBW) per day or doses in excess of 0.25 mg/kg IBW every other day. Patients on corticosteroid therapy which have not been on a stable dose for at least 28 days will also be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of treatment with 200mcg of Interferon gamma-1b administered by subcutaneous (SC) injection three times oer week (tiw) compared with placebo on survival time in patients with idiopathic pulmonary fibrosis (IPF).;Secondary Objective: To assess the safety of 200 mcg of Interferon gamma-1b administered by SC injection tiw compared with placebo in patients with IPF.;Primary end point(s): | — |
Countries
Ireland
Outcome results
None listed