- Trials with a EudraCT protocol (26)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (26)

These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006). | |
Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records. |
Study title: A Postlicensing Study to Determine Long-Term Safety of Alphanate® in Previously-Treated Patients Diagnosed with Severe Hemophilia A |
Active substance: HUMAN COAGULATION FACTOR VII |
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Document reference: 29144 |
Study title: Clinical Study of Recovery and Half-Life of Factor VII Concentrate (Human Immuno 1988-1991) |
Active substance: HUMAN COAGULATION FACTOR VII |
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Document reference: 29142 |
Study title: Compassionate Use of Factor VII, VH |
Active substance: HUMAN COAGULATION FACTOR VII |
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Document reference: 29141 |
Study title: Low risk if viral infection after administration of vapor heated factor VII concentrate or factor IX complex in first time recipients of blood components |
Active substance: HUMAN COAGULATION FACTOR VII |
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Document reference: 29140 |
Study title: Open-Label Clinical Study of Long-Term Treatment and Prophylaxis with Factor VII Concentrate (Human) Immuno, Vapor Heated" |
Active substance: HUMAN COAGULATION FACTOR VII |
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Document reference: 29138 |
Study title: Single Patient Use of Factor VII Concentrate |
Active substance: HUMAN COAGULATION FACTOR VII |
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Document reference: 29143 |
Study title: Study to determine the safety of virus inactivated factor concentrates in hemophiliacs naive to blood product administration (IFSS) |
Active substance: HUMAN COAGULATION FACTOR VII |
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Document reference: 29139 |
Study title: A study on the safety and efficacy of FEIBA VH Immuno in Hemophilia Patients with Inhibitors Hemophiliac Treatment Research Study |
Active substance: HUMAN COAGULATION FACTOR VIII |
Study summary document link (including results): 05 ATG95-03 (full).pdf |
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Document reference: 29148 |
Study title: Clinical study to investigate the efficacy, safety and immunogenicity of Wilate in children < 6 years of age with inherited von willebrand disease. |
Active substance: HUMAN COAGULATION FACTOR VIII |
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Document reference: 29157 |
Study title: Efficacy and safety in children with severe Haemophilia A treated with OCTANATE (Phase III) |
Active substance: HUMAN COAGULATION FACTOR VIII |
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Document reference: 29156 |
Study title: Efficacy of factor VIII/von Willebrand factor concentrate Alphanate in preventing excessive bleeding during surgery or invasive procedures in subjects with congenital von Willebrand disease |
Active substance: HUMAN COAGULATION FACTOR VIII |
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Document reference: 29146 |
Study title: Efficacy Study of FEIBA IMMUNO Vapor Heated Versus Factor IX Complex (Human) IMMUNO, Vapor Heated, in the Management of Patients with Hemophilia A with Inhibitors |
Active substance: HUMAN COAGULATION FACTOR VIII |
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Document reference: 29150 |
Study title: Evaluation of the Pharmacokinetic, Clinical Efficacyand Safety of the Concentrate of Factor VIII, Emoclot D.I., in patients affected by Haemophilia A |
Active substance: HUMAN COAGULATION FACTOR VIII |
Study summary document link (including results): 06 IG95-01B (full).pdf |
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Document reference: 29154 |
Study title: Familiarization Phase of FEIBA Immuno Study (Hilgartner) |
Active substance: HUMAN COAGULATION FACTOR VIII |
Study summary document link (including results): 03 IG405 (synopsis).pdf |
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Document reference: 29149 |
Study title: Human Plasma derived Antihemophilic Factor VIII: Evaluation of Efficacy, Tolerability and Safety in Previously Treated Severe Hemophilia A Patients. An Open non-Comparative Phase III Study. |
Active substance: HUMAN COAGULATION FACTOR VIII |
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Document reference: 29153 |
Study title: IG 95-01B: Retrospective pharmacovilance study. Safety study on the double-inactivated human antihaemophilic factor concentrate (Fanhdi) Grifols, during prophylaxis and/or treatment of patients with haemophilia A. |
Active substance: HUMAN COAGULATION FACTOR VIII |
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Document reference: 29151 |
Study title: Incidence of inhibitors in previously untreated patients with severe haemophilia A treated with Octanate |
Active substance: HUMAN COAGULATION FACTOR VIII |
Study summary document link (including results): 04 UK95-02 (full).pdf |
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Document reference: 29155 |
Study title: Post Marketing Pharmacovigilance Study (ATC 9503) with Profilate (SD, HT) |
Active substance: HUMAN COAGULATION FACTOR VIII |
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Document reference: 29145 |
Study title: Report UK 95-02: Retrospective review of inhibitor formation in a cohort of haemophilia A patients who received Alphanate (Alpha 8 ST) prophylactically |
Active substance: HUMAN COAGULATION FACTOR VIII |
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Document reference: 29152 |
Study title: |
Active substance: HUMAN COAGULATION FACTOR VIII AND HUMAN VON WILLEBRAND FACTOR |
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Document reference: 29159 |