A Phase 3 interventional study of Alpha-1 MP and alpha-1 proteinase inhibitor (human) in Alpha 1-Antitrypsin Deficiency, sponsored by Grifols Therapeutics LLC. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-09.
Sponsored by Grifols Therapeutics LLC · Phase 3, Interventional, and Treatment
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).
94 studies on the registry are indexed under Alpha 1-Antitrypsin Deficiency; 5 are open to participants now.
This study's enrollment of 24 is below the median of 27 across 58 interventional studies indexed under Alpha 1-Antitrypsin Deficiency.
Browse Alpha 1-Antitrypsin Deficiency studies →Grifols Therapeutics LLC is the lead sponsor of 43 studies on the registry; 4 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP
Drug: 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
Drug: alpha-1 proteinase inhibitor (human)
alpha-1 proteinase inhibitor (human), 60 mg/kg body weight
Also known as: Alpha-1 antitrypsin (AAT), TAL6004
Prolastin
Also known as: Alpha-1 antitrypsin (AAT), BAY x 5747, BAY 10-5233, TAL-05-00007
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
First-subject-first-dose was on 22 May 2006, Last-subject-last-visit was on 28 Feb 2007. The trial was performed at 6 clinical sites in the United States.
| Milestone | Alpha-1 MP / Prolastin | Prolastin / Alpha-1 MP |
|---|---|---|
| Started | 12 | 12 |
| Completed | 12 | 12 |
| Not completed | 0 | 0 |
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.
| mg*h/mL | Alpha-1 MP | Prolastin |
|---|---|---|
| Alpha-1 MP vs. Prolastin® of Area Under the Curve (AUC) From Day 0 to Day 7 | 155.9 (0.97 to 1.09) | 152.4 (0.97 to 1.09) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alpha-1 MP | — | 0/24 (0%) | 3/24 (12.5%) |
| Prolastin | — | 1/24 (4.2%) | 5/24 (20.8%) |
| Event | Alpha-1 MP | Prolastin |
|---|---|---|
| Cervical spinal stenosisMusculoskeletal and connective tissue disorders | 0/24 | 1/24 |
| Spinal osteoarthritisMusculoskeletal and connective tissue disorders | 0/24 | 1/24 |
| Event | Alpha-1 MP | Prolastin |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 2/24 | 1/24 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/24 | 2/24 |
| HeadacheNervous system disorders | 1/24 | 2/24 |
| Age, Categorical(Participants) | Alpha-1 MP / Prolastin | Prolastin / Alpha-1 MP | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 10 | 20 |
| >=65 years | 2 | 2 | 4 |
| Age, Continuous(years) | Alpha-1 MP / Prolastin | Prolastin / Alpha-1 MP | Total |
|---|---|---|---|
| Mean | 58.4 ± 6.86 | 57.0 ± 9.33 | 57.7 ± 8.04 |
| Sex: Female, Male(Participants) | Alpha-1 MP / Prolastin | Prolastin / Alpha-1 MP | Total |
|---|---|---|---|
| Female | 6 | 8 | 14 |
| Male | 6 | 4 | 10 |
| Region of Enrollment(participants) | Alpha-1 MP / Prolastin | Prolastin / Alpha-1 MP | Total |
|---|---|---|---|
| United States | 12 | 12 | 24 |
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Alpha 1-Antitrypsin Deficiency→
Grifols Therapeutics LLC