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Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults

Information source: Grifols Therapeutics Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alpha 1-Antitrypsin Deficiency

Intervention: Alpha-1 MP (Drug); alpha-1 proteinase inhibitor (human) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Grifols Therapeutics Inc.

Official(s) and/or principal investigator(s):
Kim Hanna, MSc, Study Director, Affiliation: Grifols Therapeutics Inc.

Summary

The purpose of this clinical study (ChAMP - Comparability pharmacokinetics of Alpha-1

Modified Process) is to compare the pharmacokinetic, safety and tolerability of Alpha-1 Proteinase Inhibitor (Human), modified process (Alpha-1 MP) and Prolastin in adult Alpha1-antitrypsin deficient patients. Patients will be infused intravenously with study drug on a weekly schedule for 24 weeks.

Clinical Details

Official title: Multi-center, Randomized, Double-blind, Crossover Trial to Evaluate the Pharmacokinetic Comparability of Alpha-1 MP to Prolastin in Subjects With Alpha1-antitrypsin Deficiency.

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Alpha-1 MP vs. Prolastin® of Area Under the Curve (AUC) From Day 0 to Day 7

Detailed description: The objective of this study is to demonstrate the pharmacokinetic comparability of Alpha-1 MP to Prolastin® in subjects with Alpha1-antitrypsin deficiency. This study is divided into three 8-week treatment sequences including an initial 8-week double-blind treatment period (with one of the 2 study drugs), a second 8-week double-blind treatment period (with the other study drug), and a third 8-week open-label treatment period (with Alpha-1 MP).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Documented diagnosis of congenital Alpha1-antitrypsin deficiency

- Must be receiving augmentation therapy with plasma-derived (human) Alpha1-Proteinase

Inhibitor (Prolastin®) for at least one month prior to study entry.

- Signed written informed consent prior to initiation of any study related procedures

Exclusion Criteria:

- Females who are pregnant, breast feeding, or if of child-bearing potential, unwilling

to practice adequate contraception throughout the study

- Use of systemic steroids within the 2 weeks prior to receiving study treatment (this

does not include the use of inhaled steroids used on a routine or as needed basis).

- Subjects who have had exacerbations of their disease within one month of trial entry.

Locations and Contacts

National Jewish Medical and Research Center, Denver, Colorado 80206, United States

University of Florida College of Medicine, Gainesville, Florida 32610-0225, United States

University of Miami School of Medicine, Miami, Florida 33101, United States

St Lukes-Roosevelt Hospital Center, New York, New York, New York 10019, United States

Cleveland Clinic Foundation, Cleveland, Ohio 44122, United States

Temple University Hospital, Philadelphia, Pennsylvania 19140, United States

Medical University of South Carolina, Charleston, South Carolina 29425, United States

University of Texas Health Center at Tyler, Tyler, Texas 75708-3154, United States

Additional Information

The "Alpha-1 Foundation", dedicated to providing the leadership and resources that will result in increased research, improved health, worldwide detection and a cure for Alpha-1 Antitrypsin Deficiency

AlphaNet, Inc devoted to improving the lives of individuals with Alpha-1 antitrypsin deficiency through comprehensive disease management services, clinical research administration, and consultative services

Starting date: May 2006
Last updated: August 28, 2014

Page last updated: August 23, 2015

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