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Clinical Trials/EUCTR2012-002554-23-PL
EUCTR2012-002554-23-PL
Active, not recruiting
Phase 1

Immunogenicity, Efficacy and Safety of Treatment with Human-cl rhFVIII in Previously Untreated Patients with Severe Haemophilia A

OCTAPHARMA AG0 sites108 target enrollmentFebruary 26, 2013
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ConditionsSevere Haemophilia AMedDRA version: 20.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 100000004850Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Severe Haemophilia A
Sponsor
OCTAPHARMA AG
Enrollment
108
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 26, 2013
End Date
March 24, 2020
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • •In order to qualify for study enrolment, the following criteria must be fulfilled before study entry:
  • •1\. Male patients
  • •2\. Severe haemophilia A (FVIII:C \< 1%)
  • •3\. No previous treatment with FVIII concentrates or other blood products containing FVIII
  • •4\. Voluntarily given, fully informed written and signed consent given before any study related procedures are conducted (obtained from the patient’s parent(s)/legal guardian(s))
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 100
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range 0
  • •F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

  • •Patients will not be included if any of the following exclusion criteria are met:
  • •1\. Diagnosis of a coagulation disorder other than haemophilia A
  • •2\. Severe liver or kidney disease (ALT or AST levels \>5 times of upper limit of normal (ULN), creatinine \>120 µmol/L)
  • •3\. Concomitant treatment with any systemic immunosuppressive drug
  • •4\. Participation in another interventional clinical study currently or during the past

Outcomes

Primary Outcomes

Not specified

Similar Trials

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The ability to induce an immune response, efficacy and safety of treatment with Human-cl rhFVIII in previously Untreated Patients, affected by inherited gender-related coagulation disorder ,in which affected males do not produce functional coagulation factor VIII (FVIII) in sufficient quantities to achieve satisfactory blood clotting.Severe Haemophilia AMedDRA version: 20.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 100000004850Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
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The ability to induce an immune response, efficacy and safety of treatment with Human-cl rhFVIII in previously Untreated Patients ,affected by inherited gender-related coagulation disorder ,in which affected males do not produce functional coagulation factor VIII (FVIII) in sufficient quantities to achieve satisfactory blood clotting.Severe Haemophilia AMedDRA version: 15.1Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 100000004850Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
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The ability to induce an immune response, efficacy and safety of treatment with Human-cl rhFVIII in previously Untreated Patients ,affected by inherited gender-related coagulation disorder ,in which affected males do not produce functional coagulation factor VIII (FVIII) in sufficient quantities to achieve satisfactory blood clotting.Severe Haemophilia AMedDRA version: 18.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 100000004850Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
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The ability to induce an immune response, efficacy and safety of treatment with Human-cl rhFVIII in previously Untreated Patients ,affected by inherited gender-related coagulation disorder ,in which affected males do not produce functional coagulation factor VIII (FVIII) in sufficient quantities to achieve satisfactory blood clotting.Severe Haemophilia AMedDRA version: 20.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 100000004850Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
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The ability to induce an immune response, efficacy and safety of treatment with Human-cl rhFVIII in previously Untreated Patients ,affected by inherited gender-related coagulation disorder ,in which affected males do not produce functional coagulation factor VIII (FVIII) in sufficient quantities to achieve satisfactory blood clotting.
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