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. Identifier: NCT01712438
Recruitment Status : Active, not recruiting
First Posted : October 23, 2012
Last Update Posted : June 1, 2018
Information provided by (Responsible Party):

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

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
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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 [ Time Frame: maximum 5 years (100 exposure days) ]
    Number of patients that develop an inhibitor

Secondary Outcome Measures :
  1. Efficacy [ Time Frame: Maximum 5 years (100 exposure days) ]
    Efficacy of human cl rhFVIII during prophylactic treatment (frequency of break thorugh blleds) Efficacy of human cl rhFVIII during treatment of bleeds (Number of injections needed to stop a bleed) Efficacy of human cl rhFVIII during surgical prophylaxis (compare expected estimated blood loss versus actual estimated blood loss)

Other Outcome Measures:
  1. Safety and tolerability [ Time Frame: 5 years ]
    Measure vital signs, Adverse events, and standard hematology and chemistry laboratory parameters. This assessment is descriptive)

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

Inclusion Criteria:

  • Male patients
  • Severe Hemophilia A (FVIII:C <1%)
  • No previous treatment with with FVIII concentrates or other blood prodcuts 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 identifier (NCT number): NCT01712438

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Sponsors and Collaborators

Responsible Party: Octapharma 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: June 1, 2018
Last Verified: May 2018

Keywords provided by Octapharma:
Previously untreated patients

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