Trial · NCT04953884
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Annualised Bleeding Rate (TABR) During Prophylactic Treatment With Wilate. | During 12 months of prophylactic treatment | TABR is defined as the total number of bleeding episodes (BEs) including spontaneous, traumatic, and other bleeds, occurring during the period from the first prophylactic dose of wilate to the study completion visit, divided by the duration (in years) between these two time points. Bleeding episodes that occurred during surgery periods were excluded from the calculation of TABR. Total BEs refers to all bleeding episodes that occurred during the study period, regardless of whether they were treated with wilate or not. Treated BEs are a subset of total BEs comprising of bleeding episodes that were treated with wilate. |
| Secondary | Area Under the Curve (AUC) of Wilate for VWF:Ac (VWF:RCo) Over Time | At baseline, 15 minutes, 3, 9, 24, 48 and 72 hours after dosing of 80 IU/kg BW wilate | Mean AUC of VWF:Ac after PK injection of wilate as measured by chromogenic assay. |
| Secondary | Area Under the Curve (AUC) of Wilate for FVIII (OS) Over Time | At baseline, 15 minutes, 3, 9, 24, 48 and 72 hours after dosing of 80 IU/kg BW wilate | Mean AUC of FVIII after PK injection of wilate as measured by chromogenic assay. |
| Secondary | AUC Normalised for the Administered Dose (AUCnorm) of Wilate for VWF:Ac (VWF:RCo) Over Time | At baseline, 15 minutes, 3, 9, 24, 48 and 72 hours after dosing of 80 IU/kg BW wilate | Mean AUC of VWF:Ac after PK injection of wilate, normalised for the actual administered dose (IU/kg), over time. AUC norm was measured and reported as \[h\*kg/IU\]/(dL/IU) which could also be reported as h\*kg/dL. |
| Secondary | AUC Normalised for the Administered Dose (AUCnorm) of Wilate for FVIII:C (OS) Over Time | At baseline, 15 minutes, 3, 9, 24, 48 and 72 hours after dosing of 80 IU/kg BW wilate | Mean AUC of FVIII after PK injection of wilate, normalised for the actual administered dose (IU/kg), over time. AUC norm was measured and reported as \[h\*kg/IU\]/(dL/IU) which could also be reported as h\*kg/dL. |
| Secondary | Clearance (CL) of Wilate for VWF:Ac (VWF:RCo) Over Time | At baseline, 15 minutes, 3, 9, 24, 48 and 72 hours after dosing of 80 IU/kg BW wilate | Mean clearance (CL) of VWF:Ac, measured by ristocetin cofactor assay \[VWF:RCo\]) after PK injection of wilate, calculated as the ratio of dose administered to the area under the plasma concentration-time curve (AUC), over time. Clearance was defined as the rate of drug elimination divided by plasma concentration, giving a volume of plasma from which drug is completely removed per unit of time. |
| Secondary | Clearance (CL) of Wilate for FVIII:C (OS) Over Time | At baseline, 15 minutes, 3, 9, 24, 48 and 72 hours after dosing of 80 IU/kg BW wilate | Mean clearance (CL) of FVIII:C, measured by one-stage assay \[OS\]) after PK injection of wilate, calculated as the ratio of dose administered to the area under the plasma concentration-time curve (AUC), over time. |
| Secondary | Maximum Plasma Concentration (Cmax) of Wilate for VWF:Ac (VWF:RCo) Over Time | At baseline, 15 minutes, 3, 9, 24, 48 and 72 hours after dosing of 80 IU/kg BW wilate | Mean maximum plasma concentration (Cmax) of VWF:Ac, measured by ristocetin cofactor assay \[VWF:RCo\]) after PK injection of wilate, as determined from the observed peak value in the plasma concentration-time profile. |
| Secondary | Maximum Plasma Concentration (Cmax) of Wilate for FVIII:C (OS) Over Time | At baseline, 15 minutes, 3, 9, 24, 48 and 72 hours after dosing of 80 IU/kg BW wilate | Mean maximum plasma concentration (Cmax) of FVIII:C, measured by one-stage assay \[OS\]) after PK injection of wilate, as determined from the observed peak value in the plasma concentration-time profile. |
| Secondary | Mean Residence Time (MRT) of Wilate for VWF:Ac (VWF:RCo) Over Time | At baseline, 15 minutes, 3, 9, 24, 48 and 72 hours after dosing of 80 IU/kg BW wilate | Mean residence time (MRT) of VWF:Ac, measured by ristocetin cofactor assay \[VWF:RCo\]) after PK injection of wilate, calculated as the average time a VWF:Ac molecule remains in the body, derived from the ratio of area under the first moment curve (AUMC) to AUC. |
| Secondary | Mean Residence Time (MRT) of Wilate for FVIII:C (OS) Over Time | At baseline, 15 minutes, 3, 9, 24, 48 and 72 hours after dosing of 80 IU/kg BW wilate | Mean residence time (MRT) of FVIII:C, measured by one-stage assay \[OS\]) after PK injection of wilate, calculated as the average time a FVIII:C molecule remains in the body, derived from the ratio of area under the first moment curve (AUMC) to AUC. |
| Secondary | In Vivo Half-life (T1/2) of Wilate for VWF:Ac (VWF:RCo) Over Time | At baseline, 15 minutes, 3, 9, 24, 48 and 72 hours after dosing of 80 IU/kg BW wilate | Mean in vivo half-life (T1/2) VWF:Ac, measured by ristocetin cofactor assay \[VWF:RCo\]) after PK injection of wilate, calculated as the time required for the plasma concentration to decrease by half during the terminal elimination phase. |
| Secondary | In Vivo Half-life (T1/2) of Wilate for FVIII:C (OS) Over Time | At baseline, 15 minutes, 3, 9, 24, 48 and 72 hours after dosing of 80 IU/kg BW wilate | Mean in vivo half-life (T1/2) of FVIII:C, measured by one-stage assay \[OS\]) after PK injection of wilate, calculated as the time required for the plasma concentration to decrease by half during the terminal elimination phase. |
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) of Wilate for VWF:Ac (VWF:RCo) Over Time | At baseline, 15 minutes, 3, 9, 24, 48 and 72 hours after dosing of 80 IU/kg BW wilate | Mean time to reach maximum plasma concentration (Tmax) of VWF:Ac, measured by ristocetin cofactor assay \[VWF:RCo\]) after PK injection of wilate, defined as the time from dosing to the observed peak plasma concentration. |
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) of Wilate for FVIII:C (OS) Over Time | At baseline, 15 minutes, 3, 9, 24, 48 and 72 hours after dosing of 80 IU/kg BW wilate | Mean time to reach maximum plasma concentration (Tmax) of FVIII:C, measured by one-stage assay \[OS\]) after PK injection of wilate, defined as the time from dosing to the observed peak plasma concentration. |
| Secondary | Volume of Distribution (Vd) of Wilate for VWF:Ac (VWF:RCo) Over Time | At baseline, 15 minutes, 3, 9, 24, 48 and 72 hours after dosing of 80 IU/kg BW wilate | Mean volume of distribution at steady state (Vd) of VWF:Ac, measured by ristocetin cofactor assay \[VWF:RCo\]) after PK injection of wilate, calculated as clearance (CL) multiplied by mean residence time (MRT). |
| Secondary | Volume of Distribution (Vd) of Wilate for FVIII:C (OS) Over Time | At baseline, 15 minutes, 3, 9, 24, 48 and 72 hours after dosing of 80 IU/kg BW wilate | Mean volume of distribution at steady state (Vd) of FVIII:C, measured by one-stage assay \[OS\]) after PK injection of wilate, calculated as clearance (CL) multiplied by mean residence time (MRT). |
| Secondary | Incremental In-vivo Recovery (IVR) of Wilate for VWF:Ac (VWF:RCo) Over Time | Measures were taken at the following timepoints: baseline and 1, 2, 3, 6, 9, and 12 months of treatment with IVR values reported at baseline and 12 months. | Mean incremental in vivo recovery (IVR) of VWF:Ac, measured by ristocetin cofactor assay \[VWF:RCo\]) after PK injection of wilate, calculated as the increase in plasma VWF:Ac concentration per IU/kg of wilate administered. |
| Secondary | Incremental In-vivo Recovery (IVR) of Wilate for FVIII:C (OS) Over Time | Measures were taken at the following timepoints: baseline and 1, 2, 3, 6, 9, and 12 months of treatment with IVR values reported at baseline and 12 months. | Mean incremental in vivo recovery (IVR) of FVIII:C, measured by one-stage assay \[OS\]) after PK injection of wilate, calculated as the increase in plasma FVIII:C concentration per IU/kg of wilate administered. |
| Secondary | Efficacy of Wilate Measured by the Proportion of BEs Successfully Treated With Wilate | Up to 12 months of treatment | Proportion of BEs successfully treated with wilate, as assessed using a predefined 4-point ordinal haemostatic efficacy scale. Each BE was rated at the end of treatment as "excellent", "good", "moderate", or "none" based on the time to bleeding cessation and the dose required. A BE is considered successfully treated if the efficacy rating is "excellent" (bleeding stopped within 3 days for minor bleeds, within 7 days for major bleeds, or within 10 days for gastrointestinal bleeds) or "good" (bleeding stopped, but time and/or dose slightly exceeded expectations). The outcome is reported as the percentage of BEs with a rating of "excellent" or "good" out of all treated BEs |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04953884/registered