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QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic Sclerosis

This study has been terminated.
(Concerns about risk of bronchoscopy procedure in the selected patient population and frequency of SAEs observed to date.)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00581997
First received: December 21, 2007
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Pulmonary Fibrosis Secondary to Systemic Sclerosis
 Drug: QAX576
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • - 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: December 2007
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
QAX576
 Drug: QAX576
Placebo Comparator: 2
Placebo
 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581997

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Principal Investigator: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00581997     History of Changes
Other Study ID Numbers: CQAX576A2201
Study First Received: December 21, 2007
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Pulmonary fibrosis, systemic sclerosis

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
 Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013