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A Randomized, Double-Blind, Three-Arm, Phase 3b Study Comparing the Safety and Efficacy of Interferon Gamma-1b With Azathioprine, and Azathioprine Alone in Patients With IPF Receiving Prednisone

2014-08-27 03:55:34 | BioPortfolio

Summary

Study GIPF-003 is a Phase 3b study designed to define better therapeutic use of IFN-gamma 1b in patients wtih IPF. The study will be conducted primarily in Europe and will enroll 210 patients.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Lung Disease

Intervention

interferon-gamma 1b, azathioprine

Location

Ospedale S. Luigi Gonzaga - Regione
Torino
Orbassano
Italy
10043

Status

Terminated

Source

InterMune

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:34-0400

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Medical and Biotech [MESH] Definitions

The assay of INTERFERON-GAMMA released from lymphocytes after their exposure to a specific test antigen, to check for IMMUNOLOGIC MEMORY resulting from a previous exposure to the antigen. The amount of interferon-gamma released is usually assayed by an ENZYME-LINKED IMMUNOSORBENT ASSAY.

A type II interferon produced by recombinant DNA technology. It is similar to the interferon secreted by lymphocytes and has antiviral and antineoplastic activity.

The major interferon produced by mitogenically or antigenically stimulated LYMPHOCYTES. It is structurally different from TYPE I INTERFERON and its major activity is immunoregulation. It has been implicated in the expression of CLASS II HISTOCOMPATIBILITY ANTIGENS in cells that do not normally produce them, leading to AUTOIMMUNE DISEASES.

An interferon regulatory factor that recruits STAT1 PROTEIN and STAT2 PROTEIN heterodimers to interferon-stimulated response elements and functions as an immediate-early protein.

A multimeric complex that functions as a ligand-dependent transcription factor. ISGF3 is assembled in the CYTOPLASM and translocated to the CELL NUCLEUS in response to INTERFERON signaling. It consists of ISGF3-GAMMA and ISGF3-ALPHA, and it regulates expression of many interferon-responsive GENES.

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