Clinical Trials Logo
  1. Home
  2. Idiopathic Pulmonary Fibrosis
  3. NCT00047645
  4. Details
NCT00047645 Clinical Trial

A Study of the Safety and Efficacy Interferon-Gamma 1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b in Patients With Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00047645
Other study ID # GIPF-001
Secondary ID
Status Completed
Phase Phase 3
First received October 9, 2002
Last updated November 1, 2007
Start date April 2000
Est. completion date December 2002

Study information
Verified date November 2007
Source InterMune
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Study GIPF-001 is phase 3 study designed to determine the safety and efficacy of IFN-g 1b administered by subcutaneous injection; compared to placebo in patients with IPF who are unresponsive to steroids. 330 patients have been enrolled and were assigned to either a IFN-g 1b group or a placebo group.

Recruitment information / eligibility
Status Completed
Enrollment 330
Est. completion date December 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 79 Years
Eligibility Male or Female, 20-79 years old

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Interferon-gamma 1b
200 mcg, SQ, 3x per week

Locations
Country Name City State
United States University of Washington Medical Center Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
InterMune

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression-free survival time 2 years
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05984992 - The First-in-human Study of SRN-001 in Healthy Participants Phase 1
Active, not recruiting NCT04312594 - Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis Phase 2
Recruiting NCT03865927 - GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis Phase 2
Completed NCT03979430 - Early Detection of Acute Exacerbation in Patients With Idiopathic Lung Fibrosis - a Pilot Study N/A
Enrolling by invitation NCT04905693 - Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis Phase 3
Not yet recruiting NCT06241560 - A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood Phase 2
Terminated NCT04419558 - Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF) Phase 3
Completed NCT03725852 - A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF) Phase 2
Terminated NCT03573505 - An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis Phase 2
Recruiting NCT04148157 - Quality of Life in IPF - Patient and Physician Perceptions
Completed NCT03222648 - Structured Exercise Training Programme in Idiopathic Pulmonary Fibrosis N/A
Not yet recruiting NCT06422884 - A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial) Phase 2
Completed NCT02268981 - Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF) N/A
Completed NCT02257177 - RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients Phase 1/Phase 2
Withdrawn NCT01524068 - A MultiCenter Study of Combined PEX, Rituximab, and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations Phase 2
Enrolling by invitation NCT01382368 - Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients Phase 4
Completed NCT01110694 - Prospective Observation of Fibrosis in the Lung Clinical Endpoints Study
Completed NCT01199887 - Trial Of IW001 in Patients With Idiopathic Pulmonary Fibrosis Phase 1
Active, not recruiting NCT02951416 - Clinical Course of Interstitial Lung Diseases: European IPF Registry and Biobank
Terminated NCT00981747 - Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis Phase 2/Phase 3