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Prophylaxis Versus On-demand Therapy Through Economic Report (POTTER)

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Bayer

Status

Completed

Conditions

Hemophilia A

Treatments

Drug: Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

The project is a controlled observational, multicenter, prospective data collection on secondary prophylaxis with Kogenate Bayer in adolescents and adults with severe haemophilia A (FVIII < 1%).

The observational period will cover at least 5 years per patient.

The long-term secondary prophylaxis group will be compared versus on-demand treatment group by the assessment of orthopedic status progression and pharmacoeconomics evaluation.

Enrollment

58 patients

Sex

All

Ages

12 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • age ≥ 12 years and ≤ 55 years
  • severe haemophilia A (FVIII < 1%)
  • absence of inhibitors (Bethesda titre < 0.6 BU/ml)
  • Previous Treated Patients (prior exposure days > 200)
  • Kogenate Bayer administered 20-30 IU/kg -3 times a week, for the prophylaxis group
  • ≥ 6 joint bleeds requiring treatment with FVIII concentrates in the previous 6 months before enrollment, for on-demand group
  • written informed consent

Exclusion criteria

  • concomitant severe and chronic diseases or congenital skeletal malformation
  • unreliability of patient or likelihood of follow-up failure
  • presence of inhibitors or history of inhibitors (in the previous 2 years)
  • currently on immune tolerance treatment
  • hepatic cirrhosis or liver disease in rapid progression
  • AIDS
  • platelet count < 75,000/mm3
  • presence of conditions that influence negatively patient´s compliance
  • participation in another study

Trial design

58 participants in 2 patient groups

Group 1
Treatment:
Drug: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Drug: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Group 2
Treatment:
Drug: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Drug: Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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