SPARK
A Randomized Double-blind Crossover Study to Assess the Safety and Pharmacokinetics of Two Different Doses of Weekly Intravenous Administration of Alpha1-Proteinase Inhibitor (Human) Prolastin®-C in Subjects With Alpha1-Antitrypsin Deficiency
Sponsor study identifier
interventional
30
1 country
5
Study Start
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2012
Actual (reported)Study Completion
January 2012
Actual (reported)This is a study to assess the safety and pharmacokinetics of weekly infusions of 120 mg/kg of Prolastin-C (alpha1-proteinase inhibitor \[alpha1-PI\] \[Human\]), compared to weekly infusions of 60 mg/kg of Prolastin-C in patients with alpha 1-antitrypsin deficiency (AATD).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 29, 2010
Actual (reported)October 1, 2010
Actual (reported)November 2010
Date type not reportedThis date has not been verified as actual or estimated.
January 2012
Actual (reported)January 2012
Actual (reported)May 20, 2013
Actual (reported)Subjects With Treatment-Emergent Adverse Events (TEAEs)
Number of subjects experiencing at least one TEAE. TEAEs were defined as any adverse event (AE) during the study that began on or after the date of first dose of investigational product (i.e., Prolastin-C).
22 weeks
Subjects With Drug-Related TEAE(s)
Number of subjects with at least one TEAE that was determined by the Investigator to be either "possibly related" or "related" to the investigational product (i.e., Prolastin-C).
22 weeks
Subjects With Treatment-Emergent Serious Adverse Events (SAEs)
Number of subjects who experienced at least one treatment-emergent SAE.
22 weeks
Subjects Withdrawn Due to an AE(s)
Number of subjects who were withdrawn from the study due to at least one AE.
AUC0-7days
Week 8 and Week 18 at the following timepoints: 0 (pre-infusion), completion of first infusion bag, completion of 2nd infusion bag, and 15 min, 30 min, and 1, 2, 4, 8, 24, 48, 120, and 168 hours post-dose
Mean Trough
Single measurment immediately prior to infusion at Weeks 6, 7, 8, 9 and Weeks 16, 17, 18, 19
60 mg/kg weekly infusion of Prolastin-C for 8 weeks. Subjects were infused with 60 mg/kg Prolastin-C by means of one of two possible treatment sequences: 1) 60 mg/kg weekly infusion of Prolastin-C for 8 weeks followed by 120 mg/kg Prolastin-C for 8 weeks, or 2) 120 mg/kg Prolastin-C for 8 weeks followed by 60 mg/kg weekly infusion of Prolastin-C for 8 weeks (total of 16 weeks).
120 mg/kg weekly infusion of Prolastin-C for 8 weeks. Subjects were infused with 120 mg/kg Prolastin-C by means of one of two possible treatment sequences: 1) 60 mg/kg weekly infusion of Prolastin-C for 8 weeks followed by 120 mg/kg Prolastin-C for 8 weeks, or 2) 120 mg/kg Prolastin-C for 8 weeks followed by 60 mg/kg weekly infusion of Prolastin-C for 8 weeks (total of 16 weeks).
60 mg/kg weekly infusion of Prolastin-C for 8 weeks
120 mg/kg weekly infusion of Prolastin-C for 8 weeks
University of Florida College of Medicine
Gainesville, Florida, 32610-0225, United States
University of Miami
Miami, Florida, 33136, United States
Temple University Hosptial/Temple Lung Center
Philadelphia, Pennsylvania, 19140, United States
Medical University of South Carolina, Division of Pulmonary and Critical Care Medicine
Charleston, South Carolina, 29425-6300, United States
The University of Texas Health Science Center at Tyler
Tyler, Texas, 75708, United States
Willis T, Wee K, Mohn G. A high-purity Alpha-1 proteinase inhibitor from human plasma, TAL6004. Proceeding of the 19th European Respiratory Society Annual Congress; 2009 Sep 12-16; Vienna, Austria. Abstracts;34:S53.
Mark Brantly, MD
University of Florida
Michael Campos, MD
University of Miami
Friedrich Kueppers, MD
Temple University Hospital/Temple Lung Center
James Stocks, MD
The University of Texas Health Science Center at Tyler
30 participants (actual enrollment reported by the registry).
First Submitted
September 29, 2010
First Posted
October 1, 2010
Study Start
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
Cost-Effectiveness of Lung Volume Reduction Surgery
22 weeks
Subjects With Treatment-Emergent Pulmonary Exacerbation(s)
Number of subjects with at least one treatment-emergent pulmonary exacerbation
22 weeks
Subjects With Severe TEAE(s) or Pulmonary Exacerbation(s)
Number of subjects who experienced at least one severe TEAE or pulmonary exacerbation.
22 weeks
Number of TEAEs
Total number of TEAEs reported.
22 Weeks
Number of Drug-related TEAEs
Total number of drug-related TEAEs reported
22 Weeks
Number of Treatment-Emergent Pulmonary Exacerbations
Total number of treatment-emergent pulmonary exacerbations.
22 Weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Charlie Strange, MD
Medical University of South Carolina, Division of Pulmonary and Critical Care Medicine
Primary Completion
January 2012
Actual (reported)Study Completion
January 2012
Actual (reported)Last Updated
May 20, 2013
Results First Posted
May 20, 2013
Record last verified: 2013-04
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Source: ClinicalTrials.gov.
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