An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b (IFN-Gamma 1b) in Patients With Idiopathic Pulmonary Fibrosis (IPF)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00052052
• Date of registration: 21/01/2003
• Prospective Registration: No
• Primary sponsor: InterMune
• Public title: An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b (IFN-Gamma 1b) in Patients With Idiopathic Pulmonary Fibrosis (IPF)
• Scientific title: An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis.
• Date of first enrolment: September 2002
• Target sample size: 210
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00052052
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Javier Szwarcberg, MD
• Affiliation: InterMune

Key inclusion & exclusion criteria

Male or Female

Idiopathic Pulmonary Fibrosis

20-79 years

Must have participated in the InterMune protocol GIPF-001 study.



Age minimum: 20 Years
Age maximum: 79 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Lung Disease

Pulmonary Fibrosis

Intervention(s)

Drug: interferon-gamma 1b

Primary Outcome(s)

FVC, dyspnea, DLCO, A-a gradient at rest,SGRQ,survival time, use of supplemental oxygen, QOL SF-36, TLC, time to lung transplantation or death due to IPF [Time Frame: 48 weeks]

Secondary ID(s)

GIPF-004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors