Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A
Completed · Phase 3
Conditions studied: Severe Haemophilia A
In brief
The rationale of this study is to further fine-tune and individualize prophylactic treatment of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above 1% between doses. Because trough FVIII levels are likely to be important predictors of the efficacy of prophylaxis, the focus of this study is on pharmacokinetic (PK) data.
Key facts
- Study ID
- NCT02256917
- Run by
- Octapharma
- People needed
- 58
- Starts
- 2015-05-01
- Expected to finish
- 2018-09-01
- Last updated by the study team
- 2021-01-19
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Severe Haemophilia A (FVIII:C < 1%)
- Male patients >= 18 years of age
- Previous treatment with a FVIII concentrate for at least 150 EDs
- Good documentation regarding dosing and bleeding frequency in the 6 months preceding study start
- Immunocompetence (CD4+ count > 200/uL)
You may not qualify if…
- Any coagulation disorder other than Haemophilia A
- Present of past FVIII inhibitor activity
- Severe liver or kidney disease
Where it is running
- Octapharma Research Site — Sacramento, California, United States
- Octapharma Research Site — Aurora, Colorado, United States
- Octapharma Research Site — Washington D.C., District of Columbia, United States
- Octapharma Research Site — Miami, Florida, United States
- Octapharma Research Site — Chicago, Illinois, United States
- Octapharma Research Site — Indianapolis, Indiana, United States
- Octapharma Research Site — Memphis, Tennessee, United States
- Octapharma Research Site — Houston, Texas, United States
- Octapharma Research Site — Salt Lake City, Utah, United States
- Octapharma Research Site — Edmonton, Alberta, Canada
- Octapharma Research Site — St. John's, Newfoundland and Labrador, Canada
- McMaster University — Hamilton, Ontario, Canada
- University Hospital Centre Zagreb — Zagreb, Croatia
- Helsinki University Hospital — Helsinki, Finland
- Centre Régional de Traitement de l'Hémophilie — Bron, France
- CHU Estaing — Clermont-Ferrand, France
- Centre Hospitalier Universitaire Félix Guyon — La Réunion, France
- Centre Régional de Traitement de l'hémophilie — Nantes, France
- Hôpital Purpan - Centre de Traitment Regional de l'Hemophilie Pole — Toulouse, France
- Nagoya University Hospital — Nagoya, Aichi-ken, Japan
- Hospital of the Univ of Occupational and Environmental Health — Kitakyushu, Fukuoka, Japan
- St. Marianna Univ School of Medicine Hospital — Kawasaki, Kanagawa, Japan
- Nara Medical University Hospital — Kashihara, Nara, Japan
- Gunma University Hospital — Maebashi, Japan
- Osaka National Hospital — Osaka, Japan
Full record on ClinicalTrials.gov
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