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Human-cl-rhFVIII in Previously Untreated Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT01712438
First received: October 18, 2012
Last updated: October 19, 2016
Last verified: October 2016
  Purpose
Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated patients with severe Hemophilia A.

Condition Intervention Phase
Severe Hemophilia A
Biological: Human cl rhFVIII
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Octapharma:

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


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


Enrollment: 110
Study Start Date: February 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Human cl rhFVIII Biological: Human cl rhFVIII

  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712438

  Show 37 Study Locations
Sponsors and Collaborators
Octapharma
  More Information

Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01712438     History of Changes
Other Study ID Numbers: GENA-05
2012-002554-23 ( EudraCT Number )
Study First Received: October 18, 2012
Last Updated: October 19, 2016

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

ClinicalTrials.gov processed this record on May 25, 2017