SD, IL-13 Production Rate in IPF

NCT ID: NCT00532233

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-06-30

Brief Summary

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The purpose of this study is to investigate how QAX576 affects levels of interleukin 13 (IL-13) in patients with idiopathic pulmonary fibrosis (IPF).

Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis

Keywords

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Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

QAX576

Group Type EXPERIMENTAL

QAX576

Intervention Type DRUG

Interventions

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QAX576

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men and women between the ages of 40 and 80 years with a confirmed diagnosis of idiopathic pulmonary fibrosis
* Both men and women must be on non-childbearing potential. Additional information regarding this requirement is available at screening.
* Capability to meet certain lung function tests at screening
* Non-smokers
* No participation in another clinical study within 4 weeks of study start.

Exclusion Criteria

* Certain medical conditions may exclude candidates from participation.
* Blood loss or donation of 400 mL or more within 2 months of study start Significant illness (other than respiratory) within 2 weeks of study start
* Past medical personal or close family history of clinically significant ECG abnormalities
* Connective tissue disorders
* Active infection or history of systemic parasitic infection
* Known hypersensitivity to the drug.
* History of immunocompromise, including a positive HIV test result.
* History of drug or alcohol abuse within 12 months of study start
* Any condition that may compromise patient safety
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Novartis

Role: PRINCIPAL_INVESTIGATOR

Investigative site

Locations

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Novartis Investigative Site

Denver, Colorado, United States

Site Status

Novartis Investigative Site

Atlanta, Georgia, United States

Site Status

Novartis Investigative Site

New Orleans, Louisiana, United States

Site Status

Novartis Investigative Site

Rochester, Minnesota, United States

Site Status

Novartis Investigative Site

Durham, North Carolina, United States

Site Status

Novartis Investigative Site

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=3024

Clinical Trial Results for CQAX576A2202 at Novartis Clinical Trials.com

Other Identifiers

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CQAX576A2202

Identifier Type: -

Identifier Source: org_study_id

NCT00843999

Identifier Type: -

Identifier Source: nct_alias