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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01266135 |
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Date of registration:
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17/12/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of QAX576 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
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Scientific title:
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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 |
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Date of first enrolment:
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December 2010 |
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Target sample size:
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40 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01266135 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United Kingdom
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United States
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Idiopathic Pulmonary Fibrosis
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Intervention(s)
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Drug: Placebo
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Drug: QAX576
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Primary Outcome(s)
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To evaluate the safety, tolerability, and effect on lung function of multiple intravenous doses of QAX576 in patients with IPF
[Time Frame: 1 year]
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Change in forced vital capacity (FVC) at 52 weeks as compared to baseline
[Time Frame: 1 year]
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Safety and tolerability of QAX576.
[Time Frame: 1 year]
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Secondary Outcome(s)
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Progression of fibrosis
[Time Frame: 1 year]
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Pharmacokinetics of QAX576
[Time Frame: 1 year]
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To determine the pharmacokinetics of of QAX576 by measuring concentrations of QAX576 in blood
[Time Frame: 1 year]
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To evaluate the effect of multiple intravenous doses of QAX576 on measures of clinical efficacy
[Time Frame: 1 year]
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Exacerbation of IPF
[Time Frame: 1 year]
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Time to clinical worsening:
[Time Frame: 1 year]
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Secondary ID(s)
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CQAX576A2203
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2010-020688-18
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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