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. - Preeclampsia Study with conestat alfa (C1 4101)

Pharming Technologies B.V.0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月15日

试验速览

暂无简介。

•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
•- 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.

•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

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