Trial · NCT02093897
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Success | Up to 1 year | Rate of treatment success where treatment success of a bleeding episode is defined as a rating of "excellent" or "good" based on the investigator's overall clinical assessment of hemostatic efficacy (using a 4-point scale of excellent, good, moderate or poor/no response) on the on-demand and prophylaxis regimens combined. The rate of success was based on the number of treated bleeding events; there were 347 treated bleeding events in the Efficacy Population. |
| Secondary | Annualized Bleeding Rate | Up to 1 year | The annualized bleeding rate was defined as the number of bleeding episodes requiring treatment divided by the efficacy evaluation period in days, x 365.25, and is presented separately for the on-demand regimen and the prophylaxis regimens. |
| Secondary | Percentage of Bleeding Episodes Requiring 1, 2, 3, or More Than 3 Infusions of rVIII-SingleChain to Achieve Hemostasis. | Up to 1 year | |
| Secondary | Consumption of rVIII-SingleChain - IU/kg Per Subject Per Month | Up to 1 year | |
| Secondary | Consumption of rVIII-SingleChain - IU/kg Per Subject Per Year | Up to 1 year | |
| Secondary | Consumption of rVIII-SingleChain - IU/kg Per Bleeding Event | Up to 1 year | |
| Secondary | Consumption of rVIII-SingleChain (On-demand Regimen) - Number of Infusions Per Subject Per Month | Up to 1 year | |
| Secondary | Consumption of rVIII-SingleChain (On-demand Regimen) - Number of Infusions Per Subject Per Year | Up to 1 year | |
| Secondary | Incremental Recovery | At 1 hour after the start of infusion | Incremental recovery expressed as (IU/dL)/(IU/kg) corrected for subject's predose plasma FVIII activity measured using the chromogenic substrate assay. |
| Secondary | Half-life (t1/2) of rVIII-SingleChain | Immediately before dosing, and at approximately 1, 5, 10, 24, and 48 hours after dosing. | Half-life (t1/2) of rVIII-SingleChain, baseline uncorrected; plasma FVIII activity measured using the chromogenic substrate assay. |
| Secondary | Area Under the Concentration Curve (AUC) | Immediately before dosing, and at approximately 1, 5, 10, 24, and 48 hours after dosing. | AUC to the last sample with quantifiable drug concentration (AUC0-t), baseline uncorrected; plasma FVIII activity measured using the chromogenic substrate assay. |
| Secondary | Clearance (Cl) of rVIII-SingleChain | Immediately before dosing, and at approximately 1, 5, 10, 24, and 48 hours after dosing. | Clearance (Cl) of rVIII-SingleChain, baseline uncorrected; plasma FVIII activity measured using the chromogenic substrate assay. |
| Secondary | Number of Subjects With Inhibitor Formation to rVIII-SingleChain | At screening, then after dosing at approximately monthly intervals for 6 months, then every 3 months until reaching 50 EDs, and at the end of study visit (up to approximately 12 months). | The number of subjects who develop inhibitors to rVIII-SingleChain, defined as a rVIII-SingleChain antibody titer of at least 0.6 Bethesda Units (BU) per mL after receiving study drug. |
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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