A prospective, multi-center, randomized, double blinded, placebo-controlled study for the evaluation of Iloprost in the early postoperative period after liver transplantatio

Phase 1

• Conditions: the early postoperative period after liver transplantation; MedDRA version: 17.0Level: LLTClassification code 10024716Term: Liver transplantationSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2010-022660-12-DE
• Lead Sponsor: Friedrich Schiller University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-22
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 430

Inclusion Criteria

1. Full-size liver transplantation
2. Informed consent of the patient or legal representative
3. Age = 18 years

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 370
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1.Women of child-bearing potential except women with the following criteria:
- post menopausal (12 month natural amenorrhoe or 6 month amenorrhoe with serum FSH > 40 mlU/ml)
- sterilization 86 weeks after bilateral ovarectomy with or without hysterectomy
- using an effective method of birth control for the duration of trial: implants, injectables, combined oral contraceptives, intra-uterine device (in place for a period of at least 2 months prior to screening) and with negative serum pregnancy test
- sexual abstinence
- vasectomised partner
2. Pregnancy/lactation
3. Respiratory and/or circulatory instability (noradrenaline > 1 µg/kgBW/min and FiO2 > 0.6) after LTx before randomization
4. Split liver transplantation / living donor related liver transplantation
5. Retransplantation
6. Multivisceral transplantation
7. Participation on other clinical trials 30 days prior to randomization
8. Known allergic reaction against trial medication
9. Conditions in which bleeding complications may be expected from the effect of Iloprost on platelets
10. Severe coronary artery disease or unstable angina pectoris
11. Myocardial infarction within the past 6 months prior to baseline assessment after acceptance of donor organ
12. Acute or chronic heart failure (NYHA II-IV)
13. Cardiac arrhythmias relevant for the prognosis
14. Suspected pulmonary artery congestion
15. known allergy or intolerance against tacrolimus, mycophenolate mofetil, basiliximab or corticosteroids

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified