Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
Inclusion Criteria:
1. Patient is able to communicate well with the Investigator, understands and is willing
to comply with all requirements of the study, and understands and signs the written
informed consent form (ICF).
2. At least 18 years of age.
3. Cirrhosis and ascites.
4. AKI stage 2 or 3. AKI defined by any of the following: 1) increase in SCr (SCr) ≥ 0.3
mg/dl (or ≥ 26.5 micromolar/L) within 48 h, or 2) increase ≥ 50% in baseline SCr,
which is known or presumed to have occurred within the prior seven days.
5. QLY SCr ≥ to 1.5 mg/dl.
6. No sustained improvement in renal function (less than 20% decrease in SCr and SCr =>
1.5 mg/dL) after 48 h of diuretic withdrawal and the beginning of plasma volume
expansion with albumin.
7. Female patients as well as female partners of male patients must be willing to avoid
pregnancy for the duration of the study (>90 days).
Exclusion Criteria:
1. Significant co-morbidities that in the opinion of the Investigator would preclude
study participation.
2. QLY SCr level > 5 mg/dL.
3. AKI stage 1.
4. ACLF stage 3.
5. Model for End-Stage Liver Disease (MELD) score >35.
6. At least one event of large volume paracentesis (LVP) > 4 Liters in the last 4 days
before enrollment.
7. Current or recent (within 4 weeks) treatment with nephrotoxic drugs (e.g.,
aminoglycosides, amphotericin, cyclosporine, NSAIDS (e.g., ibuprofen, naproxen,
celecoxib), significant exposure to radiographic contrast agents (large doses or
multiple injections of iodinated contrast media).
8. Shock (hypovolemic-, cardiogenic-, or vasodilatory/distributive shock) with mean
arterial blood pressure (MAP) ≤70 mmHg or systolic blood pressure ≤90 mmHg along with
hypoperfusion.
9. Sepsis or uncontrolled bacterial infection (e.g., persisting bacteremia, persisting
ascitic fluid leucocytosis, fever, increasing leucocytosis with vasomotor instability)
as measured with the quick sepsis-related organ dysfunction assessment (qSOFA) score.
10. Fewer than two days of anti-infective therapy for documented or suspected infection.
11. Superimposed acute liver injury induced by drugs, herbal preparation or dietary
supplements, with the exception of alcoholic hepatitis.
12. Estimated life expectancy less than 5 days.
13. Hypoxia (<90%) or worsening respiratory symptoms.
14. Proteinuria > 500 mg/day.
15. Tubular epithelial casts, heme granular casts.
16. Haematuria or microhaematuria (more than 50 red blood cells per high power field).
17. Abnormal renal ultra-sonography unless there is a known chronic structural disease
(e.g., diabetic or hypertensive nephropathy).
18. Current or recent (within 4 weeks) renal replacement therapy (RRT).
19. Severe cardiovascular and pulmonary diseases including, but not limited to, unstable
angina, pulmonary edema, congestive heart failure requiring increasing doses of drug
therapy, persisting symptomatic peripheral vascular disease, or any other
cardiovascular disease judged by the Investigator to be severe.
20. Transjugular intra-hepatic systemic shunt (TIPS) unless it is known to be
non-functioning or occluded.
21. Ongoing use of vasopressors, unless used for only 48 h before screening; in this case
a wash-out period of 8 h before enrollment will be necessary. Patients receiving
midodrine and octreotide may be enrolled but treatment must be discontinued prior to
enrollment.
22. Known allergy or hypersensitivity to terlipressin or other component of the study
treatment.
23. Subject is not suitable to participate in the study for any reason (including, but not
limited to co-morbidities, history of non-compliance with study visits, procedures, or
drug administration) in the opinion of the Investigator.
24. Females of childbearing potential (those who are not surgically sterilized or
post-menopausal for at least 1 year) are excluded from participation in the study
unless they agree to use highly effective contraception.
25. Males who have no sterilization history and whose female partners have child-bearing
potential must agree to use a highly effective method of contraception during the
period from the time of signing the informed consent form (ICF) through 90 days after
the last dose of study drug. A male patient must agree to immediately inform the
Investigator if his partner becomes pregnant during the study.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 4/1/2024. Questions regarding updates should be directed to the study team contact.