QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic Sclerosis
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.
ClinicalTrials.gov Identifier: NCT00581997
Recruitment Status :
(Concerns about risk of bronchoscopy procedure in the selected patient population and frequency of SAEs observed to date.)
A Randomized, Double-blinded, Placebo Controlled, Multiple-dose, Multi-center Pilot Study, to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous Doses of QAX576 in Patients With Pulmonary Fibrosis Secondary to System Sclerosis
Study Start Date :
Actual Primary Completion Date :
Resource links provided by the National Library of Medicine
- Safety assessments including vital Signs, ECG's, Echocardiograms and blood draws. - The pharmacokinetics and pharmacodynamics of multiple doses of the drug will be assessed by blood draws at the 3 dosing visits. A blood sample will also be collected. [ Time Frame: throughout the study ]
Secondary Outcome Measures :
- The effect of the drug on biomarkers of pulmonary fibrosis and systemic sclerosis. - Pulmonary function tests. - Disease specific measurements, active hand extension, oral aperture, MRSS. [ Time Frame: throughout the study ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Men and women between the ages of 18 and 65 years with a confirmed diagnosis of pulmonary fibrosis secondary to systemic sclerosis
Both men and women must be willing to use two forms of contraception. Additional information regarding this requirement is available at screening
Certain medical conditions may exclude patients from participation.
Should not have participated in another clinical study within 4 weeks of study start
Smokers are not eligible for participation
Blood loss of donation of 400 mL or more within 2 months of study start
Pregnant women or women who are breast feeding
Past medical history of clinically significant ECG abnormalities
Connective tissue disorders other than systemic sclerosis.
Active infection or history of systemic parasitic infection
History of immunodeficiency diseases, 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
Other protocol-defined inclusion/exclusion criteria may apply