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Safety and Pharmacokinetics of Alpha-1 Proteinase Inhibitor in Subjects With Alpha1-Antitrypsin Deficiency

NCT01213043 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-05-20

Study results available
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Summary

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).

Conditions

  • Emphysema
  • Alpha 1-antitrypsin Deficiency (AATD)

Interventions

BIOLOGICAL

Prolastin-C, 60 mg/kg

60 mg/kg weekly infusion of Prolastin-C for 8 weeks

BIOLOGICAL

Prolastin-C, 120 mg/kg

120 mg/kg weekly infusion of Prolastin-C for 8 weeks

Sponsors & Collaborators

  • Grifols Therapeutics LLC

    lead INDUSTRY

Principal Investigators

  • 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

  • Charlie Strange, MD · Medical University of South Carolina, Division of Pulmonary and Critical Care Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01213043 on ClinicalTrials.gov