2025-523750-14-00
Recruiting
Phase 3
A phase III randomised, double-blind, placebo-controlled, multicentre efficacy and safety clinical trial of angiotensin II in paediatric patients of 0 to 17 years of age with refractory hypotension in distributive shock receiving fluid resuscitation and standard-of-care vasopressors
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Paion Pharma GmbH
- Enrollment
- 83
Overview
Brief Summary
To evaluate the effect of angiotensin II (AT2) versus placebo on the dose of standard-of-care (SOC) vasopressors, in paediatric patients with refractory hypotension in distributive shock receiving fluid resuscitation and SOC vasopressors
Eligibility Criteria
- Ages
- 0 years to 17 years (0-17 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient 0 to 17 years of age, any gender
- •Diagnosis of refractory hypotension in distributive (= vasodilatory) shock
- •Adequate fluid resuscitation at investigator’s discretion
- •Norepinephrine base equivalent dose > 0.2 µg/kg/min when checking inclusion criteria
- •Legal representative(s) signed informed consent and patient signed assent, per applicable regulatory requirement(s). If legal representative(s) are not available in this emergency situation, the investigator may still enrol the patient in the trial, in agreement with an independent physician. In this case, both the investigator and the independent physician need to sign a declaration of emergency enrolment. If the patient is sedated, unconscious, or unable to sign assent due to another cause, they can be enrolled without signed assent. In all cases, signed informed consent and/or signed assent must retrospectively be requested as soon as possible
- •Negative pregnancy test at screening for participants of childbearing potential, i.e. after menarche
- •Venous thromboembolism prophylaxis before beginning IMP administration if indicated per local guidelines
Exclusion Criteria
- •At screening, preterm infants < 37 weeks of pregnancy and < 3.0 kg body weight at birth
- •Hypersensitivity to angiotensin II or to its excipients
- •Concurrent provision of breastfeeding
- •Current participation in another clinical trial with an investigational medicinal product not approved in that country
- •Expected survival duration < 48 hours
- •Standing Do Not Resuscitate order
- •Acute coronary syndrome
- •Acute or history of mesenteric ischaemia
- •Acute or history of major bleeding in a critical area or organ within 30 days prior to randomisation
- •Active or history of venous or arterial thrombotic or thromboembolic events or previously diagnosed coagulopathy
Investigators
Carlijn Peerboom
Scientific
Paion Pharma GmbH
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