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Human-cl-rhFVIII in Previously Untreated Patients

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ClinicalTrials.gov Identifier: NCT01712438
Recruitment Status : Active, not recruiting
First Posted : October 23, 2012
Last Update Posted : November 30, 2017
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

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
U.S. FDA Resources

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, Senior
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 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 ClinicalTrials.gov identifier (NCT number): NCT01712438


  Show 37 Study Locations
Sponsors and Collaborators
Octapharma

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: November 30, 2017
Last Verified: November 2017

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