Trial Condition(s):
Hemophilia A
Extension at 10 years of the: «Observational study evaluating efficacy and costs of secondary prophylaxis vs on-demand therapy with Kogenate Bayer in patients with severe haemophilia A.» (POTTER 10)
Bayer Identifier:
18251
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
Following the performance of the POTTER observational study, whose primary objective was to collect data on the benefits of secondary prophylaxis versus on demand treatment in terms of prevention of bleeding episodes, the present study aims to extend the observation time up to 10 years, of the same population involved in the previous study.
The present study has been designed to allow a focus on long term disease-related damage at joint level in subjects with severe haemophilia A, as well as on the pharmacoeconomics impact of the two different treatment regimens.
Inclusion Criteria
- Completion of follow-up in the original Potter study without having being excluded from the Intention To Treat efficacy analysis of the primary endpoint; - Written informed consent specifically issued for the 5-year extension.
Exclusion Criteria
- Switching of treatment to a Factor VIII concentrate different from Kogenate Bayer/Helixate NexGen after the end of the previous follow-up period.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Italy | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Extension at 10 years of the: «Observational study evaluating efficacy and costs of secondary prophylaxis vs on-demand therapy with Kogenate Bayer in patients with severe haemophilia A.» POTTER-10
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Number of joint bleeding episodes per yearTimeframe: 5 years period
Secondary Outcome
- Total number of bleeding episodes per yearTimeframe: 5 years period
- Total amount of Recombinant Factor VIII consumptionTimeframe: 5 years period
- Changes of prophylaxis doseTimeframe: 5 years period
- Changes of frequency of infusionsTimeframe: 5 years period
- Musculoskeletal evaluation by calculating the World Federation of Haemophilia Orthopedic Joint Score (Gilbert score)Timeframe: 5 years period
- Proportions of patients who will change the therapeutic regimen during the studyTimeframe: 5 years period
- Musculoskeletal evaluation by calculating the Radiological score (Pettersson Score)Timeframe: 5 years period
- Evaluating the Questionnaires of Health-Related Quality of Life _Haemo Quality of Life (HaemoQol)Timeframe: 5 years period
- Evaluating the Questionnaires of Health-Related Quality of Life _Short Form 36 questions (SF36)Timeframe: 5 years period
- Evaluating the Questionnaires of Health-Related Quality of Life _ Euro Quality 5 Dimension (EQ5D)Timeframe: 5 years period
- Number of days missed from work or school of patients and caregivers because of all the events haemophilia-relatedTimeframe: 5 years period
- Number of patients with poor complianceTimeframe: 5 years period
- Number of patients with adverse eventsTimeframe: 5 years period
Additional Information
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