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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."

NCT02581969 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2020-11-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Administered 20-30 IU/kg 3 times a week

DRUG

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Administered only for bleeding episodes

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Min Age
17 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-14
Primary Completion
2017-03-16
Completion
2018-06-21

Countries

  • Italy

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02581969 on ClinicalTrials.gov