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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."

NCT ID: NCT02581969

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-14

Study Completion Date

2018-06-21

Brief Summary

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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.

Detailed Description

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Conditions

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Hemophilia A

Keywords

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Hemophilia A, Congenital

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Prophylaxis

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

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Intervention Type DRUG

Administered 20-30 IU/kg 3 times a week

On-demand

On-demand group: treatment administered when bleeding episode occur

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Intervention Type DRUG

Administered only for bleeding episodes

Interventions

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Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Administered 20-30 IU/kg 3 times a week

Intervention Type DRUG

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Administered only for bleeding episodes

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

17 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Multiple Locations, , Italy

Site Status

Countries

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Italy

Other Identifiers

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18251

Identifier Type: -

Identifier Source: org_study_id