A Study to Determine the Safety of Ifetroban Injection in patients with Hepatorenal Syndrome (a condition of renal failure in patients with liver disease)

Phase 2

• Conditions: Health Condition 1: null- Type 1 and Type 2 Hepatorenal Syndrome

• Registration Number: CTRI/2014/09/005075
• Lead Sponsor: Cumberland Pharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 64

Inclusion Criteria

Note- There is no upper limit specified in the protocol.

Inclusion Criteria

1. Chronic liver disease, defined as cirrhosis with ascites based on clinical findings (biopsy not necessary).

2. Subjects with either Type 1 or Type 2 renal dysfunction defined as follows:

a) Type 1:

i) At least a doubling of the initial serum creatinine to >220 μmol/L

(2.5 mg/dL), occurring over a period of less than 2 weeks.

OR

ii) A 50% or greater reduction in the initial 24-hour creatinine

clearance to <20 mL/min occurring over a period of less than

2 weeks.

b) Type 2: defined as at least a 33% reduction in creatinine clearance

occurring over a period of greater than 2 weeks, with a serum creatinine

>133μmol/L (1.5 mg/dL).

3. Oliguria occurring within 48 hours prior to 1st administration CTM. Oliguria is defined as either of the following:

a. An average urine output of <35 mL/hr measured for at least 4 hours, occurring with a measured central venous pressure (CVP) >12 mmHg.

OR

b. In the absence of CVP monitoring, oliguria that is not corrected by a fluid challenge of at least 20mL/kg isotonic crystalloid or comparable volume of colloid.

Exclusion Criteria

1. History of allergy or hypersensitivity to ifetroban

2. Pregnant or nursing

3. Less than 18 years of age

4. SCr > 5.0 mg/dL

5. Platelet count at screening of <30 x 103 per μL

6. Active gastrointestinal hemorrhage

7. Evidence of obstructive or parenchymal renal disease (e.g., acute tubular necrosis, glomerular diseases, interstitial nephritis, and urinary obstruction, or lab results indicating proteinuria >500 mg/day, microhematuria [ >50 RBCs/high power field], and/or abnormal renal ultrasound scanning).

8. Current or recent (within the preceding 5 days) treatment with any of the

following drugs: aminoglycosides, acyclovir, cisplatin, methotrexate,

cyclosporine, amphotericin B.

9. Presence of shock defined as hypotension, with a mean arterial pressure less than 50 mmHG.

10. NYHA class 3 or 4 heart failure.

11. Presence of hepatocellular carcinoma not transplantable by Milan criteria

12. Cardiopulmonary arrest without full recovery of mental status

13. Moribund and death expected within five days

14. Uncontrolled bacterial or fungal infections, defined as receiving appropriate antimicrobial therapy for >24 hours

15. Burns >30% body surface area

16. Exposed to investigational drugs within 30 days before 1st CTM administration.

17. Inability to understand the requirements of the study. (Subjects must be willing to provide written informed consent or consent of legally recognized representative, as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB], and agree to abide by the study restrictions if the subject is incapacitated, informed consent will be sought from a legally recognized representative).

18. Refusal to provide written authorization for use and disclosure of protected health information.

19. Be otherwise unsuitable for the study, in the opinion of the Investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified