Trial · NCT02234310
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 32
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Confirmed Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay | Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc) | 3.03 | 95% Confidence Interval 0.08 to 15.76 | percentage of participants | |
| Annualized Number of Bleeding Episodes (Spontaneous and Traumatic) Per Participant (Annualized Bleeding Rate [ABR]) | Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc) | Episodic regimen | 0.21 | Full Range 0.0 to 6.8 | episodes per participant per year |
| Annualized Number of Bleeding Episodes (Spontaneous and Traumatic) Per Participant (Annualized Bleeding Rate [ABR]) | Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc) | Prophylaxis regimen | 1.24 | Full Range 0.0 to 5.4 | episodes per participant per year |
| Annualized Number of Spontaneous Joint Bleeding Episodes | Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc) | Episodic regimen | 0.00 | Full Range 0.0 to 5.6 | episodes per participant per year |
| Annualized Number of Spontaneous Joint Bleeding Episodes | Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc) | Prophylaxis regimen | 0.00 | Full Range 0.0 to 2.6 | episodes per participant per year |
| Number of rFIXFc Injections With Excellent or Good, Moderate or None Treatment Response Assessed Using a 4-Point Scale | Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc) | Episodic regimen / Excellent or Good | 22 | responses to injections | |
| Number of rFIXFc Injections With Excellent or Good, Moderate or None Treatment Response Assessed Using a 4-Point Scale | Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc) | Episodic regimen / Moderate | 0 | responses to injections | |
| Number of rFIXFc Injections With Excellent or Good, Moderate or None Treatment Response Assessed Using a 4-Point Scale | Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc) | Episodic regimen / None | 0 | responses to injections | |
| Number of rFIXFc Injections With Excellent or Good, Moderate or None Treatment Response Assessed Using a 4-Point Scale | Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc) | Episodic regimen / Response not provided | 58 | responses to injections | |
| Number of rFIXFc Injections With Excellent or Good, Moderate or None Treatment Response Assessed Using a 4-Point Scale | Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc) | Prophylaxis regimen / Excellent or Good | 50 | responses to injections | |
| Number of rFIXFc Injections With Excellent or Good, Moderate or None Treatment Response Assessed Using a 4-Point Scale | Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc) | Prophylaxis regimen / Moderate | 6 | responses to injections | |
| Number of rFIXFc Injections With Excellent or Good, Moderate or None Treatment Response Assessed Using a 4-Point Scale | Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc) | Prophylaxis regimen / None | 1 | responses to injections | |
| Number of rFIXFc Injections With Excellent or Good, Moderate or None Treatment Response Assessed Using a 4-Point Scale | Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc) | Prophylaxis regimen / Response not provided | 17 | responses to injections | |
| Total Number of Exposure Days (EDs) | Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc) | 76.0 | Full Range 1 to 137 | days | |
| Total Annualized rFIXFc Consumption Per Participant for the Prevention and Treatment of Bleeding Episodes | Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc) | Episodic regimen | 203.2 | Full Range 0 to 5719 | IU per kilogram per participant per year |
| Total Annualized rFIXFc Consumption Per Participant for the Prevention and Treatment of Bleeding Episodes | Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc) | Prophylaxis regimen | 3175.0 | Full Range 2544 to 13164 | IU per kilogram per participant per year |
| Number of Injections of rFIXFc Required to Resolve a Bleeding Episode | Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc) | Episodic regimen | 1.0 | Full Range 1 to 31 | injections |
| Number of Injections of rFIXFc Required to Resolve a Bleeding Episode | Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc) | Prophylaxis regimen | 1.0 | Full Range 1 to 4 | injections |
| Average Dose Per Injection of rFIXFc Required to Resolve a Bleeding Episode | Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc) | Episodic regimen | 88.50 | Full Range 41.7 to 178.6 | IU/kg |
| Average Dose Per Injection of rFIXFc Required to Resolve a Bleeding Episode | Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc) | Prophylaxis regimen | 71.92 | Full Range 23.3 to 181.8 | IU/kg |
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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