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

Primary Purpose

Alpha 1-Antitrypsin Deficiency

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Alpha-1 MP
alpha-1 proteinase inhibitor (human)
Sponsored by
Grifols Therapeutics LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alpha 1-Antitrypsin Deficiency focused on measuring alpha 1-Antitrypsin Deficiency, alpha 1-Antitrypsin, pulmonary emphysema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Jewish Medical and Research Center
  • University of Florida College of Medicine
  • University of Miami School of Medicine
  • St Lukes-Roosevelt Hospital Center, New York
  • Cleveland Clinic Foundation
  • Temple University Hospital
  • Medical University of South Carolina
  • University of Texas Health Center at Tyler

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1 Alpha-1 MP

2 Prolastin

Arm Description

Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP

Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 20, 2006
Last Updated
August 28, 2014
Sponsor
Grifols Therapeutics LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00295061
Brief Title
Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults
Acronym
ChAMP
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 Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Grifols Therapeutics LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alpha 1-Antitrypsin Deficiency
Keywords
alpha 1-Antitrypsin Deficiency, alpha 1-Antitrypsin, pulmonary emphysema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Alpha-1 MP
Arm Type
Experimental
Arm Description
Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP
Arm Title
2 Prolastin
Arm Type
Active Comparator
Arm Description
Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP
Intervention Type
Drug
Intervention Name(s)
Alpha-1 MP
Other Intervention Name(s)
Alpha-1 antitrypsin (AAT), TAL6004
Intervention Description
alpha-1 proteinase inhibitor (human), 60 mg/kg body weight
Intervention Type
Drug
Intervention Name(s)
alpha-1 proteinase inhibitor (human)
Other Intervention Name(s)
Alpha-1 antitrypsin (AAT), BAY x 5747, BAY 10-5233, TAL-05-00007
Intervention Description
Prolastin
Primary Outcome Measure Information:
Title
Alpha-1 MP vs. Prolastin® of Area Under the Curve (AUC) From Day 0 to Day 7
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Hanna, MSc
Organizational Affiliation
Grifols Therapeutics LLC
Official's Role
Study Director
Facility Information:
Facility Name
National Jewish Medical and Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
University of Florida College of Medicine
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0225
Country
United States
Facility Name
University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33101
Country
United States
Facility Name
St Lukes-Roosevelt Hospital Center, New York
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Texas Health Center at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708-3154
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20920295
Citation
Stocks JM, Brantly ML, Wang-Smith L, Campos MA, Chapman KR, Kueppers F, Sandhaus RA, Strange C, Turino G. Pharmacokinetic comparability of Prolastin(R)-C to Prolastin(R) in alpha(1)-antitrypsin deficiency: a randomized study. BMC Clin Pharmacol. 2010 Sep 30;10:13. doi: 10.1186/1472-6904-10-13.
Results Reference
derived
Links:
URL
http://www.alphaone.org
Description
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
URL
http://www.alphanet.org
Description
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

Learn more about this trial

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

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