Trial · NCT01410890
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Alglucosidase Alfa | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | Cmax was defined as maximum observed plasma concentration. |
| Primary | Pharmacokinetics: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alglucosidase Alfa | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | Tmax was defined as time to reach maximum observed plasma concentration. |
| Primary | Pharmacokinetics: Area Under the Plasma Concentration-Time Curve (AUC) of Alglucosidase Alfa | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | AUC was defined as area under the plasma concentration-time curve from time 0 to 24 hours post-dose. |
| Primary | Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Alglucosidase Alfa | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | AUC0-last was defined as area under the concentration-time curve from time 0 to the time of the last quantifiable concentration. |
| Primary | Pharmacokinetics: Terminal Elimination Half-life (T1/2) of Alglucosidase Alfa | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | T1/2 was defined as the time taken by drug to reduce to half of its initial plasma concentration. |
| Primary | Pharmacokinetics: Total Systemic Clearance (CL) of Alglucosidase Alfa | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | CL of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. |
| Primary | Pharmacokinetics: Volume of Distribution at Steady State (Vss) of Alglucosidase Alfa | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | Volume of distribution (Vd) is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss is the apparent volume of distribution at steady-state. |
| Secondary | Pharmacokinetics: Maximum Observed Plasma Concentration of Alglucosidase Alfa in Anti-Recombinant Human Acid Alpha-Glucosidase Antibody Positive and Negative Participants | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | Cmax was defined as maximum observed plasma concentration. |
| Secondary | Pharmacokinetics: Time to Reach Maximum Observed Plasma Concentration in Anti-rhGAA Antibody Positive and Negative Participants | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | Tmax was defined as time to reach maximum observed plasma concentration. |
| Secondary | Pharmacokinetics: Terminal Elimination Half-life of Alglucosidase Alfa in Anti-rhGAA Antibody Positive and Negative Participants | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | T1/2 was defined as the time taken by drug to reduce to half of its initial plasma concentration. |
| Secondary | Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of Alglucosidase Alfa in Anti-rhGAA Antibody Positive and Negative Participants | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | AUC0-last was defined as area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration. |
| Secondary | Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 and Extrapolated to Infinite Time (AUC0-inf) in Anti-rhGAA Antibody Positive and Negative Participants | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | AUC0-inf was defined as area under the concentration-time curve from time 0 extrapolated to infinite time. |
| Secondary | Pharmacokinetics: Total Systemic Clearance in Anti-rhGAA Antibody Positive and Negative Participants | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | CL of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. |
| Secondary | Pharmacokinetics: Volume of Distribution in Anti-rhGAA Antibody Positive and Negative Participants | Pre-dose and at 1, 2, 4, 8, 12, and 24 hours Post-dose on Day 1 | Vd is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss is the apparent volume of distribution at steady-state. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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