Pulmonary Fibrosis Secondary to Systemic Sclerosis Clinical Trial
Official title:
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
| NCT number | NCT00581997 |
| Other study ID # | CQAX576A2201 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | December 2007 |
| Verified date | May 2012 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will evaluate the safety, tolerability, and mechanism of action of multiple doses of QAX576 in patients with pulmonary fibrosis secondary to systemic sclerosis
| Status | Terminated |
| Enrollment | 8 |
| Est. completion date | |
| Est. primary completion date | April 2009 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | - 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. | throughout the study | ||
| Secondary | - 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. | throughout the study |