Trial · NCT01486927
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Success | Up to 24 months | The investigator rated the efficacy of the treatment based on a 4-point rating scale "excellent, good, moderate or poor/no response". Efficacy ratings of "excellent" or "good" were considered treatment success for this end point; the percentage of bleeding events with a rating of excellent or good and the 95% confidence interval are presented. The denominator includes all treated bleeding events. The 95% confidence interval is based on a model to account for within-subject correlation. |
| Primary | Inhibitor Formation to FVIII | Up to 24 months | Number of subjects who develop inhibitors to FVIII |
| Primary | Annualized Spontaneous Bleeding Rate | Up to 24 months | The annualized spontaneous bleeding rate (AsBR) was derived for each subject as follows: 365.25\*(number of spontaneous bleeding episodes requiring treatment) / (observed treatment period of interest). |
| Primary | Treatment Success During the Peri-operative Surgical Sub-study | From the start of surgery through the post-operative recovery (generally up to 14 days after surgery) | Subjects received rVIII-SingleChain before and during surgery based on the type of surgery and the clinical status of the subject. The investigator rated the efficacy of the treatment based on a 4-point surgical treatment rating scale of "excellent, good, moderate or poor/no response". Efficacy ratings of "excellent" or "good" were considered treatment success for this end point. The rate of success, defined as the percentage of surgeries with a rating of excellent or good for hemostatic efficacy on the surgical treatment scale is presented for the Surgical Population, based on the total number of surgeries (N=16) as denominator. |
| Secondary | AUC0-∞ (Part 1) | Before infusion and at up to 10 time points within 72 hours of infusion | AUC0-∞ (AUC from 0 extrapolated to infinity) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency. |
| Secondary | Cmax (Part 1) | Before infusion and at up to 10 time points within 72 hours of infusion | Cmax of a single infusion of octocog alfa and rVIII-SingleChain with correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency. |
| Secondary | Tmax (Part 1) | Before infusion and at up to 10 time points within 72 hours of infusion | Tmax = time of Cmax (with correction for subject's predose plasma FVIII activity) after a single infusion of octocog alfa and rVIII-SingleChain. |
| Secondary | Half-life (t1/2) (Part 1) | Before infusion and at up to 10 time points within 72 hours of infusion. | Half-life (t1/2) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. |
| Secondary | Mean Residence Time (MRT) (Part 1) | Before infusion and at up to 10 time points within 72 hours of infusion | Mean residence time (MRT) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. |
| Secondary | Clearance (Cl) (Part 1) | Before infusion and at up to 10 time points within 72 hours of infusion | Clearance (Cl) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency. |
| Secondary | Volume of Distribution at Steady-state (Vss) (Part 1) | Before infusion and at up to 10 time points within 72 hours of infusion | Volume of distribution at steady-state (Vss) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency. |
| Secondary | Incremental Recovery (Part 1) | At 30 minutes after infusion | Incremental recovery of a single infusion of octocog alfa and rVIII-SingleChain with correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency. |
| Secondary | Annualized Bleeding Rate for Total Bleeds and Traumatic Bleeds | Up to 24 months | The annualized bleeding rate was derived for each subject as follows: 365.25\*(number of bleeding episodes requiring treatment) / (observed treatment period of interest). |
| Secondary | Proportion of Bleeding Episodes Requiring 1, 2, 3 or > 3 Infusions of rVIII-SingleChain to Achieve Hemostasis | During the study (up to 24 months; assessed at Months 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24) | Percentage of bleeding episodes requiring 1, 2, 3 or \> 3 infusions of rVIII-SingleChain to achieve hemostasis. The denominator includes all treated bleeding episodes. |
| Other | Incremental Recovery (Part 3) | At 30 minutes after infusion | Incremental recovery of an initial and repeat infusion of rVIII-SingleChain with correction for subject's predose plasma FVIII activity. |
| Other | Volume of Distribution at Steady-state (Vss) (Part 3) | Before infusion and at up to 12 time points within 96 hours of infusion. | Volume of distribution at steady-state (Vss) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity. |
| Other | Clearance (Cl) (Part 3) | Before infusion and at up to 12 time points within 96 hours of infusion. | Clearance (Cl) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity. |
| Other | Mean Residence Time (MRT) (Part 3) | Before infusion and at up to 12 time points within 96 hours of infusion. | Mean residence time (MRT) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity. |
| Other | Half-life (t1/2) (Part 3) | Before infusion and at up to 12 time points within 96 hours of infusion. | Half-life (t1/2) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity. |
| Other | Tmax (Part 3) | Before infusion and at up to 12 time points within 96 hours of infusion. | Tmax = time of Cmax (with correction for subject's predose plasma FVIII activity) after an initial and repeat infusion of rVIII-SingleChain. |
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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