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Safety and Efficacy of QAX576 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01266135
First Posted: December 24, 2010
Last Update Posted: April 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
December 17, 2010
December 24, 2010
April 15, 2015
December 2010
April 2013   (Final data collection date for primary outcome measure)
  • To evaluate the safety, tolerability, and effect on lung function of multiple intravenous doses of QAX576 in patients with IPF [ Time Frame: 1 year ]
  • Change in forced vital capacity (FVC) at 52 weeks as compared to baseline [ Time Frame: 1 year ]
    Measure: FVC was measured using a spirometer according to American Thoracic Society / European Respiratory Society guidelines at screening and week 52 of the treatment period.
  • Safety and tolerability of QAX576. [ Time Frame: 1 year ]
    Measure safety and tolerability as assessed by reported AEs and effects on routine laboratory evaluations.
To evaluate the safety, tolerability, and effect on lung function of multiple intravenous doses of QAX576 in patients with IPF [ Time Frame: 1 year ]
Complete list of historical versions of study NCT01266135 on ClinicalTrials.gov Archive Site
  • To evaluate the effect of multiple intravenous doses of QAX576 on measures of clinical efficacy [ Time Frame: 1 year ]
  • To determine the pharmacokinetics of of QAX576 by measuring concentrations of QAX576 in blood [ Time Frame: 1 year ]
  • Time to clinical worsening: [ Time Frame: 1 year ]
    Measure: Time to clinical worsening defined as fall in FVC or Diffusing Capacity of the lung for Carbon Monoxide (DLco), lung transplant or lung disease (IPF)-related death
  • Exacerbation of IPF [ Time Frame: 1 year ]
    Measure: Incidence of exacerbation of IPF during the study
  • Progression of fibrosis [ Time Frame: 1 year ]
    Measure progression of fibrosis in the lungs as measured by Quantitative High Resolution Computerized Tomography (HRCT)
  • Pharmacokinetics of QAX576 [ Time Frame: 1 year ]
    Measure concentrations of QAX576 and its metabolites in blood throughout the study
  • To evaluate the effect of multiple intravenous doses of QAX576 on measures of clinical efficacy [ Time Frame: 1 year ]
  • To determine the pharmacokinetics of of QAX576 by measuring concentrations of QAX576 in blood [ Time Frame: 1 year ]
Not Provided
Not Provided
 
Safety and Efficacy of QAX576 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Randomized, Double-blind, Placebo-controlled, Multiple-dose, Exploratory Proof of Concept Study to Assess the Safety, Tolerability, Efficacy, Pharmacodynamic (PD) and Pharmacokinetics of QAX576 in Patients With Rapidly Progressive IPF
This study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of QAX576 in patients with idiopathic pulmonary fibrosis.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Idiopathic Pulmonary Fibrosis
  • Drug: QAX576
    QAX576 10 mg/kg intravenous infusion
  • Drug: Placebo
    Placebo to QAX576 intravenous infusion
  • Experimental: Arm 1: QAX576 10 mg/kg
    Intervention: Drug: QAX576
  • Placebo Comparator: Arm 2: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
April 2013
April 2013   (Final data collection date for primary outcome measure)

Inclusion criteria

  • Diagnosis of Idiopathic Pulmonary Fibrosis (IPF), based on an appropriate clinical definition of IPF as detailed in the ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management Diagnosis must be confirmed by a diagnostic HRCT or surgical lung biopsy.
  • A 6-minute walk test (6MWT) distance ≥50 meters at Screening (use of supplemental oxygen allowed).

Exclusion criteria

  • Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening for all subjects. Smokers will be defined as any subject who reports tobacco use or has a urine cotinine levels in the range defined as 'smokers' per the local lab.
  • Lung residual volume > 120% predicted at Screening.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   United States
 
 
NCT01266135
CQAX576A2203
2010-020688-18
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP