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Human-cl-rhFVIII in Previously Untreated Patients

This study is currently recruiting participants.
Verified March 2013 by Octapharma
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT01712438
First received: October 18, 2012
Last updated: March 15, 2013
Last verified: March 2013
History of Changes
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Hemophilia
U.S. FDA Resources

Further study details as provided by Octapharma:

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


Secondary Outcome Measures:
  • Efficacy [ Time Frame: Maximum 5 years (100 exposure days) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Measure vital signs, Adverse events, and standard hematology and chemistry laboratory parameters. This assessment is descriptive)


Estimated Enrollment: 100
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

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

Contacts
Contact: Sigurd Knaub, PhD 01141 55452141 sigurd.knaub@octapharma.com

Locations
United Kingdom
Great Ormond Street Hospital for Children Recruiting
London, United Kingdom, WC1N3JH
Contact: Raina Liesner, MD            
Principal Investigator: Raina Liesner, MD            
Sponsors and Collaborators
Octapharma
  More Information

No publications provided

Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01712438     History of Changes
Other Study ID Numbers: GENA-05, 2012-002554-23
Study First Received: October 18, 2012
Last Updated: March 15, 2013
Health Authority: United States: Food and Drug Administration
EMA: European Medical Agency

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 23, 2013