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4-PBA: Will it increase the level of Alpha 1-Antitrypsin(AAT) in persons with AAT deficiency? - Article


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Folate Deficiency

 



Clinical Trial: 4-PBA: Will it increase the level of Alpha 1-Antitrypsin(AAT) in persons with AAT deficiency?

This study is currently recruiting patients.

Sponsored by: Alpha-1 Foundation
Information provided by: Brantly, Mark L, MD

Purpose

The purpose of this study is to find out whether 4-PBA will increase the level of AAT in persons with AAT deficiency whether or not they have liver disease.

Condition Treatment or Intervention Phase
alpha 1-Antitrypsin Deficiency
  Drug: 4 Phenyl Butyrate (4PBA)
 Phase II

MedlinePlus related topics:  Alpha-1 Antitrypsin Deficiency
Genetics Home Reference related topics:  alpha-1 antitrypsin deficiency

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title: "4 Phenyl Butyrate Mediated Secretion Rescue in Alpha 1-Antitrypsin Deficient Individuals"

Further Study Details: 

Study start: November 2001

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Age 18-65
  • Serum A1-PI levels <11uM an appropriate genetic phenotype/genotype
  • 5 of 10 subjects must have documented laboratory evidence of liver disease
  • Willingness to withold Prolastin therapy for 6 weeks prior to screening and throughout the 4-PBA dosing period (up to 3 months)

Exclusion Criteria:

  • Any cause of liver disease other than Alpha-1 Antitrypsin deficiency
  • Evidence of advanced liver disease
  • HIV positive
  • Use of systemic steroids, ursodeoxycholic acid (Actigall, Urso), or herbs in the prior 6 months

Location and Contact Information

Dawn Baker, MSN      (352) 392-8284    dawn@alphaone.ufl.edu
Pam Schreck, MSN      (352)294-0512    pschreck@ufl.edu

Florida
      University of Florida Health Science Center, Gainesville,  Florida,  32610-0225,  United States; Recruiting

Study chairs or principal investigators

Mark L Brantly, MD,  Principal Investigator,  University of Florida   

More Information

Alpha-1 Foundation Alpha-1 Research Program

Study ID Numbers:  87-2001
Record last reviewed:  August 2003
Last Updated:  October 13, 2004
Record first received:  August 26, 2003
ClinicalTrials.gov Identifier:  NCT00067756
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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November 25, 2009


Page Updated: October 15, 2009
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