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Pharmacokinetic Study of ARALAST (Human Alpha1- PI)
Phase 1 trial testing Dose of 60 mg/kg Fraction IV-1 Alpha1-Proteinase Inhibitor in Alpha 1-Antitrypsin Deficiency in 25 participants. Completed in 5 June 2006.
| Lead sponsor | Baxalta now part of Shire |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 20 December 2005 |
| Primary completion | 5 June 2006 |
| Estimated completion | 5 June 2006 |
| Sites | 7 locations across New Zealand, Australia |
Baxalta now part of Shire — full company profile →
18 and older, any sex, with Alpha 1-Antitrypsin Deficiency. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Area under the plasma alpha1-proteinase inhibitor (α1-PI) concentration versus time curve (AUC) calculated by linear trapezoidal method per dose.
| Group | Value | 95% CI |
|---|---|---|
| ARALAST Fr. IV-1 | 0.0822 | 0.0750 – 0.094 |
| ARALAST | 0.0920 | 0.0804 – 0.098 |
Total area under the α1-PI concentration vs. time curve from pharmacokinetic day 0 to time infinity (AUC 0-infinity) per dose
| Group | Value | 95% CI |
|---|---|---|
| ARALAST Fr. IV-1 | 0.0825 | 0.0750 – 0.095 |
| ARALAST | 0.0928 | 0.0812 – 0.099 |
Computed as dose divided by AUC 0-infinity (AUC 0-infinity was calculated as the sum of AUC from time 0 to the time of last quantifiable concentration plus a tail area correction)
| Group | Value | 95% CI |
|---|---|---|
| ARALAST Fr. IV-1 | 951 | 782 – 1115 |
| ARALAST | 856 | 782 – 918 |
Computed as total area under the moment curve (AUMC) divided by total AUC
| Group | Value | 95% CI |
|---|---|---|
| ARALAST Fr. IV-1 | 6.8 | 4.5 – 7.8 |
| ARALAST | 6.9 | 5.8 – 7.5 |
Computed as weight-adjusted CL \* MRT
| Group | Value | 95% CI |
|---|---|---|
| ARALAST Fr. IV-1 | 5606 | 4624 – 6162 |
| ARALAST | 5405 | 4454 – 6703 |
Computed from the terminal or disposition rate constant obtained from log\_e -linear fitting using the least squares deviation to the last five quantifiable concentrations above pre-infusion level.
| Group | Value | 95% CI |
|---|---|---|
| ARALAST Fr. IV-1 | 4.1 | 3.1 – 5.4 |
| ARALAST | 4.2 | 4.0 – 5.2 |
Maximum α1-PI concentration following infusion
| Group | Value | 95% CI |
|---|---|---|
| ARALAST Fr. IV-1 | 1.7 | 1.4 – 1.8 |
| ARALAST | 1.7 | 1.5 – 1.8 |
Time to reach C-max. Tmax is the number of days from infusion to maximum concentration. Samples drawn at the end of infusion are considered to be time zero.
| Group | Value | 95% CI |
|---|---|---|
| ARALAST Fr. IV-1 | 0.00 | 0.00 – 0.00 |
| ARALAST | 0.00 | 0.00 – 0.00 |
Computed from Cmax (mg/ml) divided by dose per kg body weight (mg/kg).
| Group | Value | 95% CI |
|---|---|---|
| ARALAST Fr. IV-1 | 0.0259 | 0.0234 – 0.028 |
| ARALAST | 0.0258 | 0.0237 – 0.027 |
Investigators assessed severity of AEs (occurring during or after infusions) based on: MILD: Transient discomfort, does not interfere in a significant manner with participant's normal functioning level; Resolves spontaneously or may require minimal therapeutic intervention MODERATE: AE produces limited impairment of function, can require therapeutic intervention; AE produces no sequelae; SEVERE: AE results in marked impairment of function, can lead to temporary inability to resume usual life pattern; AE produces sequelae, which require prolonged therapeutic intervention
| Group | Value | 95% CI |
|---|---|---|
| ARALAST Fr. IV-1 | 0 | |
| ARALAST | 0 |
| Group | Value | 95% CI |
|---|---|---|
| ARALAST Fr. IV-1 | 43 | |
| ARALAST | 45 |
| Group | Value | 95% CI |
|---|---|---|
| ARALAST Fr. IV-1 | 16 | |
| ARALAST | 12 |
| Group | Value | 95% CI |
|---|---|---|
| ARALAST Fr. IV-1 | 2 | |
| ARALAST | 3 |
Time frame: Throughout the entire study period (7 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | ARALAST Fr. IV-1 | ARALAST |
|---|---|---|---|
| Headache | Nervous system disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Vessel puncture site bruise | General disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Contusion | Injury, poisoning and procedural complications | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Muscle strain | Musculoskeletal and connective tissue disorders | — | — |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Lethargy | Nervous system disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Blister | Skin and subcutaneous tissue disorders | — | — |
Data from ClinicalTrials.gov NCT00242385 adverse events section.
The primary purpose of this study is to characterize the pharmacokinetic profile of intravenous Aralast Fraction (Fr.) IV-1, a sterile, stable, lyophilized preparation of functionally intact human Alpha1- Proteinase Inhibitor (α1-PI). This pharmacokinetic study will be a randomized controlled clinical trial with a cross-over design. Twenty-four subjects will be enrolled into the study. Overall study duration will be approximately 6-8 months.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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