Trial · NCT01480180
Registered outcomes75
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 75
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Incidence Rate of FVIII-inhibitors ≥0.6 BU: After Approximately 19 Months | After approximately 19 months | All participants with neutralizing antibodies were included in the numerator and any participant with a minimum 50 exposure days plus any participant with inhibitory inhibitors was included in the denominator. A positive inhibitor test was defined as ≥0.6 bethesda unit (BU). Estimates are based on exact calculations for a binomial distribution. For the calculation of the 'inhibitor rate' the nominator included all participants with neutralising antibodies while the denominator included all participants with a minimum of 50 exposures plus any participant with less than 50 exposures but with neutralising inhibitors. |
| Primary | Annualised Bleeding Rate in the Prophylaxis Arm: After Approximately 19 Months | After approximately 19 months | Annualised bleeding rate (ABR) is the number of bleeding episodes per year. This was assessed only for the prophylaxis treatment with N8-GP. |
| Primary | The Incidence Rate of FVIII-inhibitors ≥0.6 BU: After Approximately 25 Months | After approximately 25 months | All participants with neutralizing antibodies were included in the numerator and any participant with a minimum 50 exposure days plus any participant with inhibitory inhibitors was included in the denominator. A positive inhibitor test was defined as ≥0.6 bethesda unit (BU). Estimates are based on exact calculations for a binomial distribution. For the calculation of the 'inhibitor rate' the nominator included all participants with neutralising antibodies while the denominator included all participants with a minimum of 50 exposures plus any participant with less than 50 exposures but with neutralising inhibitors. |
| Primary | Annualised Bleeding Rate in the Prophylaxis Arm: After Approximately 25 Months | After approximately 25 months | ABR is the number of bleeding episodes per year. This was assessed only for the prophylaxis treatment with N8-GP. |
| Primary | Incidence Rate of FVIII-inhibitors ≥0.6 BU: At Approximately 80 Months | At approximately 80 months | All participants with neutralizing antibodies were included in the numerator and any participant with a minimum 50 exposure days plus any participant with inhibitory inhibitors was included in the denominator. A positive inhibitor test was defined as ≥0.6 bethesda unit (BU). Estimates are based on exact calculations for a binomial distribution. For the calculation of the 'inhibitor rate' the nominator included all participants with neutralising antibodies while the denominator included all participants with a minimum of 50 exposures plus any participant with less than 50 exposures but with neutralising inhibitors. |
| Primary | Annualised Bleeding Rate in the Prophylaxis Arm: After Approximately 80 Months | After approximately 80 months | Annualised bleeding rate (ABR) is the number of bleeding episodes per year reported during the prophylactic treatment with N8-GP. |
| Secondary | Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 19 Months | After approximately 19 months | Haemostatic effect of N8-GP for treatment of bleeding episodes was assessed by 4-point response scale: none, moderate, good or excellent. Evaluation during trial was done by participant and/or parent(s)/caregiver within approximately 8 hours after a single injection as follows: Excellent: Abrupt pain relief and/or clear improvement in objective signs of bleeding within approximately 8 hrs after a single injection; Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hrs after a single injection, but possibly requiring more than one injection for complete resolution; Moderate: Probable or slight beneficial effect within approximately 8 hours after the first injection, but usually requiring more than one injection; None: No improvement, or worsening of symptoms. |
| Secondary | Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 25 Months | After approximately 25 months | Haemostatic effect of N8-GP for treatment of bleeding episodes was assessed by 4-point response scale: none, moderate, good or excellent. Evaluation during trial was done by participant and/or parent(s)/caregiver within approximately 8 hours after a single injection as follows: Excellent: Abrupt pain relief and/or clear improvement in objective signs of bleeding within approximately 8 hrs after a single injection; Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hrs after a single injection, but possibly requiring more than one injection for complete resolution; Moderate: Probable or slight beneficial effect within approximately 8 hours after the first injection, but usually requiring more than one injection; None: No improvement, or worsening of symptoms. |
| Secondary | Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 80 Months | After approximately 80 months | Haemostatic effect of N8-GP for treatment of bleeding episodes was assessed by 4-point response scale: none, moderate, good or excellent. Evaluation during trial was done by participant and/or parent(s)/caregiver within approximately 8 hours after a single injection as follows: Excellent: Abrupt pain relief and/or clear improvement in objective signs of bleeding within approximately 8 hrs after a single injection; Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hrs after a single injection, but possibly requiring more than one injection for complete resolution; Moderate: Probable or slight beneficial effect within approximately 8 hours after the first injection, but usually requiring more than one injection; None: No improvement, or worsening of symptoms. |
| Secondary | Consumption of N8-GP Per Bleeding Episode (Number of Infusions): After Approximately 19 Months | After approximately 19 months | The mean number of infusions of N8-GP used for treatment of a bleed from start to stop of a bleed was reported. |
| Secondary | Consumption of N8-GP Per Bleeding Episode (Number of Infusions): After Approximately 25 Months | After approximately 25 months | The mean number of infusions of N8-GP used for treatment of a bleed from start to stop of a bleed was reported. |
| Secondary | Consumption of N8-GP Per Bleeding Episode (Number of Infusions): After Approximately 80 Months | After approximately 80 months | The mean number of infusions of N8-GP used for treatment of a bleed from start to stop of a bleed was reported. |
| Secondary | Consumption of N8-GP Per Bleeding Episode (U/kg): After Approximately 19 Months | After approximately 19 months | The mean consumption of N8-GP (U/kg) used for treatment of a bleed from start to stop of a bleed was reported. |
| Secondary | Consumption of N8-GP Per Bleeding Episode (U/kg): After Approximately 25 Months | After approximately 25 months | The mean consumption of N8-GP (U/kg) used for treatment of a bleed from start to stop of a bleed was reported. |
| Secondary | Consumption of N8-GP Per Bleeding Episode (U/kg): After Approximately 80 Months | After approximately 80 months | The mean consumption of N8-GP (U/kg) used for treatment of a bleed from start to stop of a bleed was reported. |
| Secondary | Consumption of N8-GP (Number of Infusions) During Prophylaxis and On-demand Treatment: After Approximately 19 Months | After approximately 19 months | Number of infusions are presented as average dose used during propphylaxis and on-demand treatment. |
| Secondary | Consumption of N8-GP (Number of Infusions) During Prophylaxis and On-demand Treatment: After Approximately 25 Months | After approximately 25 months | Number of infusions are presented as average dose used during prophylaxis and on-demand treatment. |
| Secondary | Consumption of N8-GP (Number of Infusions) During Prophylaxis and On-demand Treatment: After Approximately 80 Months | After approximately 80 months | Number of infusions are presented as average dose used during prophylaxis and on-demand treatment. |
| Secondary | Consumption of N8-GP (U/kg Per Month) During Prophylaxis and On-demand Treatment: After Approximately 19 Months | After approximately 19 months | The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed (per month per participant) was reported. |
| Secondary | Consumption of N8-GP (U/kg Per Month) During Prophylaxis and On-demand Treatment: After Approximately 25 Months | After approximately 25 months | The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed (per month per participant) was reported. |
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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GET https://conductscience.org/api/trials/v1/NCT01480180/registered