Trial · NCT02932618
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hemostatic Efficacy | Within 24 hours after the last infusion of study drug following the onset of the bleeding episode (if/when the severity and/or duration of the bleeding requires the infusion of the study drug) | Treatment success for vonicog alfa-treated nonsurgical bleeding episodes (using a 4-point scale: Excellent, Good, Moderate, None). |
| Secondary | Number of Treated Nonsurgical Bleeding Episodes With an Efficacy Rating of 'Excellent' or 'Good' | Throughout the study duration of approximately 8.5 years | If/when the severity and/or duration of the bleeding requires the infusion of the study drug. |
| Secondary | Number of Infusions per Bleeding Episode | Throughout the study duration of approximately 8.5 years | |
| Secondary | Number of Vonicog Alfa Units per Bleeding Episode | Throughout the study duration of approximately 8.5 years | |
| Secondary | Number of ADVATE Units (if needed) per Bleeding Episode | Throughout the study duration of approximately 8.5 years | |
| Secondary | Elective or Emergency Surgery: Assessment of Hemostatic Efficacy - Immediately After Surgery | Immediately after surgery | Assessed by the operating surgeon, based on a 4-point ordinal scale: Excellent, Good, Moderate, None. |
| Secondary | Elective or Emergency Surgery: Overall Assessment of Hemostatic Efficacy 24 Hours After the Last Perioperative Infusion of rVWF | 24 hours after last perioperative rVWF infusion | Assessed by the Investigator (hematologist) on a 4-point ordinal scale: Excellent, Good, Moderate, None. |
| Secondary | Elective or Emergency surgery: Overall Assessment of Hemostatic Efficacy Day 7 Post-operative | Post-operative Day 7 | Assessed by the Investigator (hematologist) on a 4-point ordinal scale: Excellent, Good, Moderate, None. |
| Secondary | Elective or Emergency surgery: Overall Assessment of Hemostatic Efficacy Day 14 Post-operative | Post-operative Day 14 | Assessed by the Investigator (hematologist) on a 4-point ordinal scale: Excellent, Good, Moderate, None. |
| Secondary | Incidence and Severity of Adverse Events (AEs) | Throughout the study period of approximately 8.5 years | |
| Secondary | Incidence of Thromboembolic Events | Throughout the study period of approximately 8.5 years | |
| Secondary | Incidence of Severe Hypersensitivity Reactions | Throughout the study period of approximately 8.5 years | |
| Secondary | Development of Neutralizing Antibodies to von Willebrand Factor (VWF) and Factor VIII (FVIII) | Throughout the study period of approximately 8.5 years | |
| Secondary | Development of Total Binding Antibodies to von Willebrand Factor (VWF) | Throughout the study period of approximately 8.5 years | |
| Secondary | Development of Antibodies to Chinese Hamster Ovary (CHO) Proteins, Murine Immunoglobulin G (IgG), and rFurin | Throughout the study period of approximately 8.5 years | |
| Secondary | Area Under the Plasma Concentration/Time Curve From 0 to 96 Hours Post-Infusion (AUC0-96h) for Von Willebrand factor: ristocetin cofactor (VWF:Rco), von Willebrand factor: antigen (VWF:Ag) and von Willebrand factor: collagen binding capacity (VWF:CB) | Within 30 minutes prior to infusion and post infusion at: SEQUENCE 1: 1, 24, 72 hours; SEQUENCE 2: 0.25, 12, and 48 hours; SEQUENCE 3: 6, 30, and 96 hours | |
| Secondary | Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-inf) for VWF:RCo, VWF:Ag and VWF:CB | Within 30 minutes prior to infusion and post infusion at: SEQUENCE 1: 1, 24, 72 hours; SEQUENCE 2: 0.25, 12, and 48 hours; SEQUENCE 3: 6, 30, and 96 hours | |
| Secondary | Mean Residence Time (MRT) for VWF:RCo, VWF:Ag and VWF:CB | Within 30 minutes prior to infusion and post infusion at: SEQUENCE 1: 1, 24, 72 hours; SEQUENCE 2: 0.25, 12, and 48 hours; SEQUENCE 3: 6, 30, and 96 hours | |
| Secondary | Time to Reach Maximal Plasma Concentration (Tmax) for VWF:RCo, VWF:Ag and VWF:CB | Within 30 minutes prior to infusion and post infusion at: SEQUENCE 1: 1, 24, 72 hours; SEQUENCE 2: 0.25, 12, and 48 hours; SEQUENCE 3: 6, 30, and 96 hours | |
| Secondary | Maximal Plasma Concentration (Cmax) for VWF:RCo, VWF:Ag and VWF:CB | Within 30 minutes prior to infusion and post infusion at: SEQUENCE 1: 1, 24, 72 hours; SEQUENCE 2: 0.25, 12, and 48 hours; SEQUENCE 3: 6, 30, and 96 hours |
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.
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GET https://conductscience.org/api/trials/v1/NCT02932618/registered