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Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01712438
Recruitment Status : Active, not recruiting
First Posted : October 23, 2012
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Octapharma

Brief Summary:
Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated patients with severe Hemophilia A.

Condition or disease Intervention/treatment Phase
Severe Hemophilia A Biological: Human cl rhFVIII Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunogenicity, Efficacy and Safety of Treatment With Human-cl-rhFVIII in Previously Untreated Patients With Severe Hemophilia A
Study Start Date : February 2013
Actual Primary Completion Date : December 14, 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia
Drug Information available for: Chlorine

Arm Intervention/treatment
Experimental: Human cl rhFVIII Biological: Human cl rhFVIII



Primary Outcome Measures :
  1. Immunogenicity of Human-cl rhFVIII [ Time Frame: maximum 5 years (100 exposure days) ]
    Number of patients that develop an inhibitor in 100 previously untreated patients (PUPs) suffering from severe Haemophilia A (FVIII:C < 1%)


Secondary Outcome Measures :
  1. Frequency of spontaneous break-through bleeds [ Time Frame: Maximum 5 years (100 exposure days) ]
    Frequency of spontaneous break-through bleeds during prophylactic treatment with human cl rhFVIII

  2. Number of injections needed to stop a bleed [ Time Frame: Maximum 5 years (100 exposure days) ]
    Number of injections of human cl rhFVIII needed to stop a bleed

  3. Average expected estimated blood loss versus actual blood loss [ Time Frame: Maximum 5 years (100 exposure days) ]
    Average expected estimated blood loss will be compared to actual blood loss during surgical prophylaxis with human cl rhFVIII. Prior to surgery, the surgeon will provide written estimates of volume (mL) of average expected blood loss for the planned surgical procedure, as it would be expected for the same procedure in a patient with normal haemostasis, of the same sex, age, and stature. Following the surgery, the actual blood loss will be estimated by the surgeon.


Other Outcome Measures:
  1. The occurrence of any adverse event (AE) [ Time Frame: 5 years ]
    The frequency of AEs, as monitored throughout the whole study



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male patients
  • Severe Hemophilia A (FVIII:C <1%)
  • No previous treatment with with FVIII concentrates or other blood products containing FVIII

Exclusion Criteria:

  • Diagnosis with a coagulation disorder other than Hemophilia A
  • Severe liver or kidney disease
  • Concomitant treatment with any systemic immunosuppressive drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01712438


  Show 37 Study Locations
Sponsors and Collaborators
Octapharma
Investigators
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Study Director: Sigurd Knaub Octapharma

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Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01712438     History of Changes
Other Study ID Numbers: GENA-05
2012-002554-23 ( EudraCT Number )
First Posted: October 23, 2012    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019

Keywords provided by Octapharma:
Previously untreated patients

Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn