E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pregnant women with a history of recurrent pregnancy loss, defined as:
- 2 or more early (< 12 weeks of gestation) pregnancy losses or - 1 or more late (> 12 weeks of gestation) pregnancy loss
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036562 |
E.1.2 | Term | Pregnancy in habitual aborter |
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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 |
Can the rate of pregnancy losses before the 24th week of gestation be reduced by dalteparin treatment?
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E.2.2 | Secondary objectives of the trial |
Can the rate of live births be increased by dalteparin treatment? Can the rate of late pregnancy complications (preterm delivery, placenta insufficiency, intrauterine growth retardation, preeclampsia and abruptio placentae) be reduced by dalteparin treatment? Description and comparison of the rate of foetal structural anomalies Description and comparison of symptomatic venous thrombembolic events during the pregnancy Description of the side effects of dalteparin (e.g. thrombocytopenia, osteoporosis, haemorrhage)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients must meet ALL of the following criteria:
Single pregnancy, 5th to 8th week of gestation Documented foetal heart activity in US History of recurrent pregnancy loss, defined as: -2 or more early (< 12 weeks of gestation) pregnancy losses or -1 or more late (> 12 weeks of gestation) pregnancy loss Age > 18 years Written informed consent of the patient
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E.4 | Principal exclusion criteria |
Patients will be excluded for ANY ONE of the following reasons: Previous pregnancy losses caused by foetal structural or chromosomal anomalies Uterine anomalies Maternal infection which caused previous pregnancy loss Risk group II or III according to ETHIG I risk stratification (clinical need for heparin prophylaxis) Acute thromboembolic event (need of heparin therapy) Known hypersensitivity to any of the trial drugs or its ingredients (i.e. thrombocytopenia type II caused by allergic reaction to heparin) Antiphospholipid antibody syndrome Diabetes mellitus Ongoing nicotine or drug or alcohol abuse HIV positive Expected low compliance (e.g. by travel distance to trial site) Current or recent (within 30 days prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial Injuries or surgeries of CNS, eyes or ear during the last 8 weeks prior to randomisation Active clinical significant bleeding (e.g. gastrointestinal, intracranial, intraocular) during the last 3 months prior to randomisation Diseases associated with enhanced predisposition of bleeding (e.g. hemorrhagic diathesis, deficiency of coagulation factors, severe affection of liver, kidney or pancreas, severe thrombocytopenia) Diseases caused by lesions of the vascular system (e.g. gastric, peptic or intestinal ulcer, hypertension (RR diast. > 105 mmHg, hemorrhagic apoplectic insult (3 month prior to randomisation), aneurysm of brain artery, retinopathies, bleeding of vitreous body, endocarditis lenta or septica) Renal and urethra calculi
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point is ongoing intact pregnancy at 24 weeks of gestation. |
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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 | Yes |
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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 19 |
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 | Yes |
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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End of the trial is defined as last follow-up visit after delivery of the last child of the last subject undergoing the trial
In case of the following situations, a premature termination of the trial has to be considered: Serious adverse drug reactions leading to substantial changes in risk-benefit considerations Not justifiable toxicity Insufficient efficacy New insights from other trials Insufficient recruitment rate Unsustainable trial organization
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |