A Phase I/II, Open Label, Proof of Concept Study to investigate Tolerability and Safety of Treatment with Recombinant Human C1 Inhibitor (conestat alfa) in Patients with Preeclampsia.

Phase 2

Completed

Conditions: pregnancy hypertension
pregnancy poisoning
10026908

Registration Number: NL-OMON48732

Lead Sponsor: Pharming Technologies B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

1. Hospitalized pregnant females, aged >= 18 years
2. Singleton pregnancy
3. Between 27 and 34 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, hemolysis))
c. Uteroplacental dysfunction
- fetal growth restriction
5. Provided written informed consent.
6. Willingness and ability to comply with all protocol procedures.

Exclusion Criteria

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
conestat alfa)
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 before pregnancy.
8. Patient with known renal and/or hepatic abnormality before pregnancy
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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>• Incidence and severity of adverse events<br /><br>• Number and percentage of patients who discontinue study drug or withdraw from<br /><br>the study </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>• Time from start of rhC1INH (conestat alfa) to day of delivery<br /><br>• Proportion of patients reaching gestation week 37.</p><br>