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.”

Brief Title

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."

Official Title

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

Brief 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.

Study Type

Observational

Primary Outcome

Number of joint bleeding episodes per year

Secondary Outcome

 Total number of bleeding episodes per year

Condition

Hemophilia A

Intervention

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Study Arms / Comparison Groups

 Prophylaxis

Description:  Prophylaxis group: treatment is based on regularly repeated infusions of clotting factor, 20-30 IU/kg -3 times a week

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

April 14, 2016

Completion Date

June 21, 2018

Primary Completion Date

March 16, 2017

Eligibility Criteria

        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.

Gender

Male

Ages

17 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Bayer Study Director, ,

Location Countries

Italy

Location Countries

Italy

Administrative Informations

NCT ID

NCT02581969

Organization ID

Responsible Party

Sponsor

Study Sponsor

Bayer

Study Sponsor

Bayer Study Director, Study Director, Bayer

Verification Date

November 2020