Prospective, Open-label, Multi-centre Phase 3b Study to Assess the Efficacy and Safety of Personalized Prophylaxis With Human-cl rhFVIII in Previously Treated Adult Patients With Severe Haemophilia A

Status: Completed
Location: See all (29) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: No
View:

• 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)

Locations
United States
California
Octapharma Research Site
Sacramento
Colorado
Octapharma Research Site
Aurora
Washington, D.c.
Octapharma Research Site
Washington
Florida
Octapharma Research Site
Miami
Illinois
Octapharma Research Site
Chicago
Indiana
Octapharma Research Site
Indianapolis
Tennessee
Octapharma Research Site
Memphis
Texas
Octapharma Research Site
Houston
Utah
Octapharma Research Site
Salt Lake City
Other Locations
Canada
Octapharma Research Site
Edmonton
McMaster University
Hamilton
Octapharma Research Site
St. John's
Croatia
University Hospital Centre Zagreb
Zagreb
Finland
Helsinki University Hospital
Helsinki
France
Centre Régional de Traitement de l'Hémophilie
Bron
CHU Estaing
Clermont-ferrand
Centre Hospitalier Universitaire Félix Guyon
La Réunion
Centre Régional de Traitement de l'hémophilie
Nantes
Hôpital Purpan - Centre de Traitment Regional de l'Hemophilie Pole
Toulouse
Japan
Nara Medical University Hospital
Kashihara
St. Marianna Univ School of Medicine Hospital
Kawasaki
Hospital of the Univ of Occupational and Environmental Health
Kitakyushu
Gunma University Hospital
Maebashi
Nagoya University Hospital
Nagoya
Osaka National Hospital
Osaka
Ogikubo Hospital
Tokyo
Teikyo University Hospital
Tokyo
Netherlands
University Medical Center Groningen
Groningen
Slovenia
University Medical Centre Ljubljana
Ljubljana
Time Frame
Start Date: May 2015
Completion Date: September 2018
Participants
Target number of participants: 58
Treatments
Experimental: Human-cl rhFVIII
Related Therapeutic Areas
Sponsors
Leads: Octapharma

This content was sourced from clinicaltrials.gov

Similar Clinical Trials