A study to investigate the tolerance and safety of treatment in patients with preeclampsia
- Conditions
- PreeclampsiaTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2018-002904-14-NL
- Lead Sponsor
- Pharming Technologies B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 30
1. Pregnant females, aged = 18 years
2. Singleton pregnancy
3. Between 25 and 35 weeks of gestation
4. Diagnosis of pre-eclampsia defined as hypertension developing after 20 weeks gestation and the coexistence of one or more of the following new onset conditions:
a. Proteinuria (spot urine protein/creatinine =30 mg/mmol [0.3 mg/mg] or =300 mg/day or at least 1 g/l [‘2+’] on dipstick testing)
b. Other maternal organ dysfunction:
- renal insufficiency (creatinine =90 Umol/l)
- liver involvement (elevated transaminases – at least twice upper limit of normal ± right upper quadrant or epigastric abdominal pain)
- neurological complications (examples include eclampsia, altered mental status, blindness, stroke, or more commonly hyperreflexia when accompanied by clonus, severe headaches when accompanied by hyperreflexia, persistent visual scotomata)
- hematological complications (thrombocytopenia – platelet count below 150,000/dL, DIC, hemolysis))
c. Uteroplacental dysfunction
- fetal growth restriction
5. Provided written informed consent.
6. Willingness and ability to comply with all protocol procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Impending Fetal death compromise – absent end-diastolic umbilical artery flow, pathological CTG
2. Any known fetal abnormality
3. Patients diagnosed with hereditary angioedema (HAE)
4. Medical history of allergy to rabbits or rabbit-derived products (including rhC1INH)
5. Treatment with any investigational drug during the current pregnancy
6. Patient with known chronic hypertension requiring antihypertensive treatment
7. Patient with abnormalities in their clotting system.
8. Patient with known renal and/or hepatic abnormality
9. Patient with a history of malignancy (except if determined cured or on remission for at least 5 years)
10. Medical history of any organ transplants
11. Uncontrolled diabetes, defined as HbA1C > 7%
12. Currently treated with statins
13. Any other condition or treatment that, in the opinion of the Investigator, might interfere with the evaluation of study objectives
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: Primary: <br> To evaluate the tolerability and safety of the treatment with rhC1INH on top of Standard Care, for patients with preeclampsia.<br> <br> <br> ;<br> Secondary Objective: Secondary: <br> To evaluate the efficacy of treatment with rhC1INH on top of Standard Care, for patients with preeclampsia.<br> ;<br> Primary end point(s): - Incidence and severity of adverse events<br> - Number and percentage of patients who discontinue study drug or withdraw from the study <br> ;Timepoint(s) of evaluation of this end point: Throughout the study
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): - Time from start of rhC1INH to day of delivery<br> - Proportion of patients reaching gestation week 37<br> ;Timepoint(s) of evaluation of this end point: At birth