E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Severe Acute Haemorrhage (SAH) The main clinical situations of SAH are trauma and surgery-related haemorrhages and obstretical haemorrheges. Othopedic procedures can induce SAH. One of the most haemorrhagic types of surgery is revision total hip arthroplasty (THA). For the purpose of the study patient with elective revision THA including major acetabular and/or femoral reconstruction. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066691 |
E.1.2 | Term | Acute haemorrhage |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the study is to assess the clinical efficacy of 2 dose regimens of FGT1 in reducing peri-operative bleeding in patients undergoing revision THA. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are: To assess the clinical efficacy of 2 dose regimens of FGT1 in reducing transfusion needs, To assess the safety of 2 dose regimens of FGT1 in patients undergoing revision THA.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Signed and dated informed consent form, 2.Age > 18 years old, 3.For women of childbearing potential, a pregnancy test before inclusion and a medically acceptable method of birth control throughout the study are required, 4.Known serology status (including vaccination), 5.Elective revision THA including major acetabular and/or femoral reconstruction, 6.Covered by healthcare insurance in accordance with local requirements.
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E.4 | Principal exclusion criteria |
1.Congenital bleeding disorder, 2.Personal history of thrombosis (deep vein thrombosis, pulmonary embolism, cerebral thrombosis), 3.Anaemia (Hb < 10 g/dL), 4.Total white blood cells > 12000 cells/mm3, 5.Platelets < 100 G/L, 6.Plasma fibrinogen concentration > 4 g/L, 7.Revision of infected THA, 8.Plasma creatinine > 120 µmol/mL 9.Pregnancy or breastfeeding, 10.Known history of hypersensitivity or other severe reaction to any component of the investigational medicinal products, including placebo or any component, administered during the study, 11.Treatment with any investigational medicinal product or participation in another clinical study within 30 days prior to screening, 12.Previously randomised in this clinical study, 13.Known neoplastic disorder that is currently active or currently treated with a drug known to have a thrombotic effect, 14.Current clinically significant gastrointestinal, neurological, renal, hepatic, endocrine, cardiac or pulmonary disease, diabetes, hypertension, asthma or COPD that is not well controlled, 15.Tranexamic acid use, 16.Erythropoietin use within 3 months prior to screening and during study, 17.Drug or alcohol abuse, 18.Patients with abnormalities in physical examination or laboratory results that, in the opinion of the Investigator, are deemed to be clinically significant, 19.Patients whose use of concomitant medication may interfere with the interpretation of data, 20.Anticipated poor compliance of patient with study procedures.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of this study is the calculated volume of peri-operative blood loss. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 13 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 13 |