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

Grifols Therapeutics LLC24 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Alpha 1-Antitrypsin Deficiency

Interventions

Alpha-1 MPDRUG

alpha-1 proteinase inhibitor (human), 60 mg/kg body weight

alpha-1 proteinase inhibitor (human)DRUG

Prolastin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (8)

National Jewish Medical and Research Center

Denver, Colorado, United States

University of Florida College of Medicine

Gainesville, Florida, United States

University of Miami School of Medicine

Miami, Florida, United States

St Lukes-Roosevelt Hospital Center, New York

Outcomes

Primary Outcomes

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

The primary objective of this study was to demonstrate the pharmacokinetic comparability (geometric least square mean ratio of AUC between the Alpha-1 MP vs. Prolastin®, 90% confidence interval falls within 0.80-1.25, FDA Guidance as being "bioequivalent" between two treatments) of Alpha-1 MP to Prolastin® in subjects with alpha-1-anti-trypsin (AAT) deficiency by comparing AUC from Day 0 to Day 7 of plasma Alpha1-PI measured by the functional activity (potency) assay. AUC from Day 0 to Day 7 was calculated at steady state at the end of the first and second 8-week treatment periods during the 16-week double-blind, crossover phase.

Time frame: Day 0 to Day 7

Data from ClinicalTrials.gov

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