NCT00075998

Brief Summary

  • Purpose: A phase 3, randomized, double-blind, placebo-controlled trial to determine the efficacy and safety of 200 µg of recombinant Interferon gamma-1b administered by subcutaneous (SC) injection, compared with placebo, in patients with IPF
  • Enrollment: Approximately 800 patients will be enrolled from approximately 80 centers in North America and Europe
  • Randomization: 2:1 active-to-placebo ratio
  • Duration: at least 2 years active drug or placebo (rescue therapy will be permitted for patients who meet predefined criteria)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
826

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2003

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2004

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

July 2, 2009

Status Verified

July 1, 2009

First QC Date

January 12, 2004

Last Update Submit

July 1, 2009

Conditions

Idiopathic Pulmonary FibrosisLung DiseasePulmonary Fibrosis

Keywords

IdiopathicPulmonaryFibrosisIPFLungInterferonGammaActimmuneINSPIREInterMune

Outcome Measures

Primary Outcomes (1)

  • Survival time from randomization to treatment completion visit, or, end of treatment period, or, last known vital status.

    3.5 years

Secondary Outcomes (3)

  • Lung transplant-free survival time (ongoing assessment up to end of study).

    3.5 years

  • Total number of days without hospitalization resulting from respiratory admission diagnosis (ongoing assessment up to end of study).

    3.5 years

  • Changes from baseline measurement to week 96 measurement in the following (measured every 24 weeks): 6-minute walk test, shortness of breath

    96 weeks

Interventions

Interferon gamma-1b ("Actimmune")DRUG

200 mcg, SQ, 3x per week

Eligibility Criteria

Age40 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical symptoms consistent with IPF of \>= 3 months duration
  • Diagnosis of IPF within 48 months before randomization
  • Age 40 through 79, inclusive
  • High-resolution computed tomographic scan (HRCT) showing definite IPF. For patients with surgical lung biopsy showing definite or probable usual interstitial pneumonia (UIP), the HRCT criterion of probable IPF is sufficient.
  • For patients aged \< 50 years: open or video-assisted thoracoscopic (VATS) lung biopsy showing definite or probable UIP within 48 months before randomization. In addition, there are no features supporting an alternative diagnosis on transbronchial biopsy or bronchoalveolar lavage (BAL) if performed.
  • For patients aged \< 50 years: At least one of the following diagnostic findings, as well as the absence of any features on specimens resulting from any of these procedures that support an alternative diagnosis, within 48 months before randomization:
  • Open or VATS lung biopsy showing definite or probable UIP
  • Transbronchial biopsy showing no features to support an alternative diagnosis
  • BAL showing no features to support an alternative diagnosis IPF Disease Severity and Progression
  • FVC \>= 55% of predicted value (post administration of bronchodilator)
  • Hemoglobin (Hb)-corrected carbon monoxide diffusing capacity/carbon monoxide transfer capacity (DLCO/TLCO) \>= 35% of predicted value
  • At least one of either FVC or Hb-corrected DLCO/TLCO \<= 90% of predicted value
  • IPF disease progression evidenced by one or more of the following within the past year and the absence of evidence of improvement in the past year:
  • Absolute decrease of \>= 10% in FVC
  • Absolute decrease of \>= 15% in DLCO/TLCO
  • +3 more criteria

You may not qualify if:

  • Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study, in the opinion of the Principal Investigator (PI)
  • Forced expiratory volume in the first second (FEV1)/FVC ratio \< 0.6 (after administration of bronchodilator)
  • Residual volume (RV) \> 140% of predicted (before administration of bronchodilator)
  • History of clinically significant environmental exposure known to cause pulmonary fibrosis (including but not limited to drugs, asbestos, beryllium, radiation, domestic birds)
  • Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, and cancer
  • Diagnosis of any connective tissue disease, including but not limited to scleroderma, systemic lupus erythematosus, and rheumatoid arthritis
  • Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis, urinary tract infection, and cellulitis
  • On a lung transplantation waiting list at time of randomization
  • Any history of malignancy likely to result in death, significant disability, or likely to require significant medical or surgical intervention within the next 3 years. This does not include minor surgical procedures for localized carcinoma (e.g., basal cell carcinoma)
  • Any condition other than IPF which, in the opinion of the PI, is likely to result in the death of the patient within the next 3 years
  • History of unstable or deteriorating cardiac, vascular, or neurologic disease within the previous 6 months, including but not limited to the following:
  • Myocardial infarction, unstable angina pectoris, coronary artery bypass surgery, or coronary angioplasty
  • Congestive heart failure requiring hospitalization
  • Uncontrolled arrhythmias
  • Thromboembolic event (e.g., deep vein thrombosis, pulmonary embolism)
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

InterMune, Inc.

Brisbane, California, 94005, United States

Location

Related Publications (7)

  • Wells AU, Jacob J, Sverzellati N, Cross G, Barnett J, De Lauretis A, Antoniou K, Weycker D, Atwood M, Kirchgaessler KU, Cottin V. A formula for predicting emphysema extent in combined idiopathic pulmonary fibrosis and emphysema. Respir Res. 2024 Jan 18;25(1):33. doi: 10.1186/s12931-023-02589-x.

    PMID: 38238788DERIVED

  • Allen RJ, Stockwell A, Oldham JM, Guillen-Guio B, Schwartz DA, Maher TM, Flores C, Noth I, Yaspan BL, Jenkins RG, Wain LV; International IPF Genetics Consortium. Genome-wide association study across five cohorts identifies five novel loci associated with idiopathic pulmonary fibrosis. Thorax. 2022 Aug;77(8):829-833. doi: 10.1136/thoraxjnl-2021-218577. Epub 2022 Jun 10.

    PMID: 35688625DERIVED

  • Kreuter M, Lee JS, Tzouvelekis A, Oldham JM, Molyneaux PL, Weycker D, Atwood M, Kirchgaessler KU, Maher TM. Monocyte Count as a Prognostic Biomarker in Patients with Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2021 Jul 1;204(1):74-81. doi: 10.1164/rccm.202003-0669OC.

    PMID: 33434107DERIVED

  • Kreuter M, Lederer DJ, Molina-Molina M, Noth I, Valenzuela C, Frankenstein L, Weycker D, Atwood M, Kirchgaessler KU, Cottin V. Association of Angiotensin Modulators With the Course of Idiopathic Pulmonary Fibrosis. Chest. 2019 Oct;156(4):706-714. doi: 10.1016/j.chest.2019.04.015. Epub 2019 Apr 29.

    PMID: 31047956DERIVED

  • Cottin V, Hansell DM, Sverzellati N, Weycker D, Antoniou KM, Atwood M, Oster G, Kirchgaessler KU, Collard HR, Wells AU. Effect of Emphysema Extent on Serial Lung Function in Patients with Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2017 Nov 1;196(9):1162-1171. doi: 10.1164/rccm.201612-2492OC.

    PMID: 28657784DERIVED

  • du Bois RM, Albera C, Bradford WZ, Costabel U, Leff JA, Noble PW, Sahn SA, Valeyre D, Weycker D, King TE Jr. 6-Minute walk distance is an independent predictor of mortality in patients with idiopathic pulmonary fibrosis. Eur Respir J. 2014 May;43(5):1421-9. doi: 10.1183/09031936.00131813. Epub 2013 Dec 5.

    PMID: 24311766DERIVED

  • King TE Jr, Albera C, Bradford WZ, Costabel U, Hormel P, Lancaster L, Noble PW, Sahn SA, Szwarcberg J, Thomeer M, Valeyre D, du Bois RM; INSPIRE Study Group. Effect of interferon gamma-1b on survival in patients with idiopathic pulmonary fibrosis (INSPIRE): a multicentre, randomised, placebo-controlled trial. Lancet. 2009 Jul 18;374(9685):222-8. doi: 10.1016/S0140-6736(09)60551-1. Epub 2009 Jun 29.

    PMID: 19570573DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary FibrosisLung DiseasesPulmonary FibrosisFibrosis

Interventions

interferon gamma-1b

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • InterMune, Inc.

    Medical Information

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 12, 2004

First Posted

January 14, 2004

Study Start

December 1, 2003

Study Completion

May 1, 2007

Last Updated

July 2, 2009

Record last verified: 2009-07

Locations

US(1)