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Grifols Therapeutics Inc. conducted a multi-center, randomized, double-blind, crossover study to evaluate the safety, immunogenicity, and pharmacokinetics (PK) of Liquid Alpha₁-PI compared to the currently licensed product, Prolastin-C, in subjects with Alpha₁-Antitrypsin Deficiency (AATD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1 | Other | Subjects were treated first with Liquid Alpha₁-PI and then treated with Prolastin-C |
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| Treatment Sequence 2 | Other | Subjects were treated first with Prolastin-C and then treated with Liquid Alpha₁-PI |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liquid Alpha₁-PI | Biological | Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-7 Days) Based on Antigenic Content | The primary PK objective of this study was to demonstrate the bioequivalence of Liquid Alpha₁-PI 60 mg/kg to Prolastin-C 60 mg/kg, as measured by AUC from 0 to 7 days (AUC0-7days) using an antigenic content assay of alpha₁-PI, at approximate steady state in subjects with AATD. | pre-dose, 0, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 1 day, 2 days, 5 days, 7 days post dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-7 Days) Based on Functional Activity | The exploratory PK objective of this study was to demonstrate the bioequivalence of Liquid Alpha₁-PI 60 mg/kg to Prolastin-C 60 mg/kg, as measured by AUC from 0 to 7 days (AUC 0-7 days) using a functional activity assay of alpha₁-PI, at approximate steady state in subjects with AATD. | pre-dose, 0, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 1 day, 2 days, 5 days, 7 days post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Denver | Colorado | 80206 | United States | ||
| University of Florida Gainesville |
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This study was performed at 6 investigative centers in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Liquid Alpha₁-PI/Prolastin-C | Subjects were treated first with Liquid Alpha₁-PI and then treated with Prolastin-C Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions |
| FG001 | Prolastin-C/Liquid Alpha₁-PI |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Prolastin-C | Biological | Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions |
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| Number of Subjects With Immunogenicity Response | Blood samples for immunogenicity testing were collected at Weeks 1 (Baseline), 9, 17, and 20. Any samples that tested positive for alpha₁-PI antibodies were tested for neutralizing antibodies and antibody titer. Immunogenicity testing was performed using validated assays in a multitiered approach. Samples collected at Week 1 (Baseline) and at Weeks 9 and 20 were tested for immunogenicity while samples collected at Week 17 were to be tested for immunogenicity only if deemed appropriate (eg, unexpected PK profile). | Weeks 1, 9, 17, and 20 |
| Gainesville |
| Florida |
| 32610 |
| United States |
| University of Miami - Miller School of Medicine | Miami | Florida | 33136 | United States |
| PMG Research of Wilmington | Wilmington | North Carolina | 28401 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| University of Texas Health Science Center | Tyler | Texas | 75708 | United States |
Subjects were treated first with Prolastin-C and then treated with Liquid Alpha₁-PI Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Liquid Alpha₁-PI/Prolastin-C | Subjects were treated first with Liquid Alpha₁-PI and then treated with Prolastin-C Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions |
| BG001 | Prolastin-C/Liquid Alpha₁-PI | Subjects were treated first with Prolastin-C and then treated with Liquid Alpha₁-PI Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Alpha1-PI concentration | One subject in the Liquid Alpha₁-PI/Prolastin -C non-naïve population was missing baseline alpha₁-PI concentration due to sample instability. | Mean | Standard Deviation | mg/mL |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUC(0-7 Days) Based on Antigenic Content | The primary PK objective of this study was to demonstrate the bioequivalence of Liquid Alpha₁-PI 60 mg/kg to Prolastin-C 60 mg/kg, as measured by AUC from 0 to 7 days (AUC0-7days) using an antigenic content assay of alpha₁-PI, at approximate steady state in subjects with AATD. | Posted | Mean | Standard Deviation | mg*h/mL | pre-dose, 0, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 1 day, 2 days, 5 days, 7 days post dose |
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| Secondary | AUC(0-7 Days) Based on Functional Activity | The exploratory PK objective of this study was to demonstrate the bioequivalence of Liquid Alpha₁-PI 60 mg/kg to Prolastin-C 60 mg/kg, as measured by AUC from 0 to 7 days (AUC 0-7 days) using a functional activity assay of alpha₁-PI, at approximate steady state in subjects with AATD. | Posted | Mean | Standard Deviation | mg*h/mL | pre-dose, 0, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 1 day, 2 days, 5 days, 7 days post dose |
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| Secondary | Number of Subjects With Immunogenicity Response | Blood samples for immunogenicity testing were collected at Weeks 1 (Baseline), 9, 17, and 20. Any samples that tested positive for alpha₁-PI antibodies were tested for neutralizing antibodies and antibody titer. Immunogenicity testing was performed using validated assays in a multitiered approach. Samples collected at Week 1 (Baseline) and at Weeks 9 and 20 were tested for immunogenicity while samples collected at Week 17 were to be tested for immunogenicity only if deemed appropriate (eg, unexpected PK profile). | Posted | Count of Participants | Participants | Weeks 1, 9, 17, and 20 |
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20 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liquid Alpha₁-PI | Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions | 0 | 32 | 9 | 32 | ||
| EG001 | Prolastin-C | Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions | 1 | 31 | 3 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (17.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
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The site may publish results from the study, after providing Sponsor at least 30 days notice prior to submitting a manuscript or other materials related to the study to any outside party. At Sponsor's request, Site will remove any any confidential information (other than study results), and incorporate all reasonable comments by Sponsor, or delay publication or presentation for a period of up to 120 days to allow Sponsor to protect its interests in any Sponsor's Inventions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Henry Li | Grifols Therapeutics Inc. | 1-919-316-6042 | henry.li@grifols.com |
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| Non-naive |
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