N/A
N=86
PROPACT: Retrospective Prophylaxis Patient Case Collection
Congenital Bleeding Disorder · Haemophilia A With Inhibitors · Haemophilia B With Inhibitors
Bottom Line
View on ClinicalTrials.gov: NCT00882778 ↗Enrolled (actual)
86
Serious AEs
1.2%
Results posted
Jul 2011
Primary outcome: Primary: Percent Change in Total Bleed Episodes Per Month - Bleeding Population — -45 percent change (%) in bleeds per month
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- eptacog alfa (activated) (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Male
- Sponsor
- Novo Nordisk A/S
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Total Bleed Episodes Per Month - Bleeding Population |
-45 | — |
| PRIMARY Percent Change in Total Bleed Episodes Per Month - Frequent Bleeding Population |
-51 | — |
| PRIMARY Percent Change in Total Bleed Episodes Per Month Per Age Categories - Bleeding Population |
-48; 0; -56 | — |
| PRIMARY Percent Change in Total Bleed Episodes Per Month Per Age Categories - Frequent Bleeding Population |
-56; 5; -49 | — |
| PRIMARY Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Bleeding Population, Infrequent Dosing |
-6; -6; 0; 0 | — |
| PRIMARY Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Bleeding Population, Dosing Three Times Per Week |
-52; -50; 12; -72 | — |
| PRIMARY Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Bleeding Population, Daily Dosing |
-48; -48; -43; -51 | — |
| PRIMARY Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Bleeding Population, Frequent Dosing |
-18; -47; 40; 35 | — |
| PRIMARY Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Frequent Bleeding Population, Infrequent Dosing |
-6; -6; 0; 0 | — |
| PRIMARY Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Frequent Bleeding Population, Dosing Three Times Per Week |
-56; -57; -10; -76 | — |
| PRIMARY Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Frequent Bleeding Population, Daily Dosing |
-59; -62; 47; -51 | — |
| PRIMARY Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Frequent Bleeding Population, Frequent Dosing |
33; -13; 0; 35 | — |
| SECONDARY Individual Dose by Dose Regimen and Age Group - Bleeding Population, Paediatric |
133.3; 185.4; 141.9; 135 | — |
| SECONDARY Individual Dose by Dose Regimen and Age Group - Bleeding Population, Adolescent |
0; 198; 138.9; 138 | — |
| SECONDARY Individual Dose by Dose Regimen and Age Group - Bleeding Population, Adult |
0; 159.7; 117.6; 103.3 | — |
| SECONDARY Individual Dose by Dose Regimen and Age Group - Frequent Bleeding Population, Paediatric |
133.3; 197.2; 135.9; 131 | — |
| SECONDARY Individual Dose by Dose Regimen and Age Group - Frequent Bleeding Population, Adolescent |
0; 138; 280; 0 | — |
| SECONDARY Individual Dose by Dose Regimen and Age Group - Frequent Bleeding Population, Adult |
0; 162; 117.6; 103.3 | — |
| SECONDARY Total Bleed Episodes Per Month by Joint, Target Joint and Non-joint - Bleeding Population |
-39; -50; -33 | — |
| SECONDARY Total Bleed Episodes Per Month by Joint, Target Joint and Non-joint - Frequent Bleeding Population |
-46; -56; -42 | — |
| SECONDARY Healthcare Resource Consumption of Visits, Consultations, and Hospital Admissions Per Month - All Patients |
-0.011; 0.043; -0.097 | — |
| SECONDARY Healthcare Resource Consumption of Visits, Consultations and Hospital Admissions Per Month - Bleeding Population |
0.0090; 0.053; -0.11 | — |
| SECONDARY Healthcare Resource Consumption of Visits, Consultations and Hospital Admissions Per Month - Frequent Bleeding Population |
0.0576; 0.213; -0.11 | — |
| SECONDARY Healthcare Resource Consumption of Total Hospital Length of Stay and School/Work Absences Per Month - All Patients |
-0.654; -1.365 | — |
| SECONDARY Healthcare Resource Consumption of Total Hospital Length of Stay and School/Work Absences Per Month - Bleeding Population |
-0.794; -1.365 | — |
| SECONDARY Healthcare Resource Consumption of Total Hospital Length of Stay and School/Work Absences Per Month - Frequent Bleeding Population |
-1.064; -1.927 | — |
| SECONDARY Physician Reported Outcome Assessment in Prophylaxis in Number of Patients |
35; 20; 7; 9; 15 | — |
| SECONDARY Number of Physician Reported Outcome Assessment in Prophylaxis in Percentage of Patients |
40; 23; 8; 10; 17 | — |
Summary
This study is conducted in Europe and North and South America. The primary aim of this observational study is to evaluate the frequency and pattern of bleeding episodes in haemophilia patients receiving preventative treatment with activated recombinant human factor VII. The secondary aim is to evaluate which patients are selected for this treatment, the dose and dose intervals used, and the safety of activated recombinant human factor VII when used as prevention. The study also aims to increase understanding of the unmet medical need and clinical relevance of preventative treatment in haemophilia patients.
Eligibility Criteria
Inclusion Criteria
- Haemophilia A or B with inhibitors
- Prescribed use of activated recombinant human factor VII for any type of prophylaxis with a duration of at least 30 days
Exclusion Criteria
- Prophylaxis prescribed post-surgery
- One or more coagulation disorders in addition to haemophilia
Data sourced from ClinicalTrials.gov (NCT00882778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.