E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Early and severe preeclampsia with low antithrombin activity. |
Tidigt debuterande och svår havandeskapsförgiftning med låg antitrombin aktivitet. |
|
E.1.1.1 | Medical condition in easily understood language |
Women with early, severe preeclampsia and low antithrombin activity, an important inhibitor of blood coagulation, is a complication with hypertension, proteinuri and increased risk of prematurity.
|
|
E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
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 |
To study blood flow in uterine artery duirng infusion of Atenativ and to study how myck Atenativ has to be administered to maintain normal antithrombin activity during two weeks. |
|
E.2.2 | Secondary objectives of the trial |
Secondary the outcome of pregnancy and neonatal status will be studied. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Women with severe early-onset preeclampsia during gestational week 23-29+0.
2. Severe preeclampsia as defined by international criteria (1,2)
• Blood pressure >160/110 mmHg (measured twice 30 minutes apart).
proteinuria (>5 .0 g/L per 24 hours or >3 + labstick in at least two random
samples six hours apart) after 20th gestational week.
• Blood pressure >140/90 mmHg and proteinuria >5.0 g/24 h.
• preeclampsia ( blood pressure > 140/90 and proteinuria >0.3 g/24 h) with IUGR or subjective symptoms as epigastic pain (HELLP), headache, dizziness or visual disturbancies, oligouri < 600 ml/24 h, coagulation disturbancies.
3. AT level <0.8 kIE/LC
|
|
E.4 | Principal exclusion criteria |
1. History of congenital AT deficiency
2. Severe preeclampsia with demand on acute delivery within 24 hours according to the investigators judgement
3. Concomitant administration of anticoagulants and platelet inhibitors within 2 weeks
4. Chronic renal disease
5. Diabetes melittus or gestational diabetes
6. Intrauterine fetal death
7. Participation in another clinical study
8. Multiple pregnancies |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Blood flow in a uterine artery during infusion of Atenativ
Amount Atenativ needed to maitain normal antithrombin activity during twp weeks from inclusion. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
During infusion of Atenativ |
|
E.5.2 | Secondary end point(s) |
Outcome of pregnancy and neonatal status |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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 | No |
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.8.5 | The trial involves multiple Member States | No |
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 | No |
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
|
2 months after the last patient´s delivery. |
|
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 | |
E.8.9.1 | In the Member State concerned days | |