Cardiox Liver Function Test Pivotal Trial

• Status: Withdrawn
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Performance evaluation of LFT Dye Monitor System using ICG - plasma disappearance rate value (PDR) to assess liver function in normal patients as well as in patients with mild to severe hepatic impairment compared to manual Serum ICG PDR.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cardiox Corporation

Criteria

Inclusion Criteria:

1. Male or female between 18 to 75 years of age inclusive, at the time of Screening.

2. Voluntarily provide written informed consent.

3. Female patients are eligible only if all of the following apply:

• Not pregnant (negative urine pregnancy test at the Screening visit);

• Not lactating;

• Not planning to become pregnant within the duration of the study;

• Surgically sterile, or at least 2 years postmenopausal, or is practicing an acceptable form of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, subdermal implant, oral contraceptives, abstinence, or sterilization of monogamous partner) for greater than 60 days prior to Screening and commits to the use of the acceptable form of birth control for the duration of the study.

4. If a healthy volunteer; is considered to be in generally good health, in the opinion of the Investigator, at the Screening visit based upon the results of their medical and surgical history, vital signs, physical examination, and clinical laboratory tests.

5. Prior to receiving any ICG injections the subject agrees to be fasting for at least eight (8) hours.

6. If a subject with liver cirrhosis; is considered to be in general satisfactory health, in the opinion of the Investigator (other than their hepatic impairment) at the Screening visit based upon the results of their medical and surgical history, vital signs, physical examination, and non-hepatic clinical laboratory tests.

7. Liver cirrhosis subjects must have a clinical diagnosis of hepatic impairment based on documented evidence of hepatic cirrhosis by medical history, or previous liver biopsy, or hepatic ultrasound; which conforms to the criteria for class A or B or C of the Childs-Pugh classification (Appendix B); and are expected to require an ICG liver function study, such as for liver transplantation, liver resection, liver cirrhosis prognosis evaluation, functional liver cell mass and/or general liver dysfunction evaluations.

8. On stable drug therapy that is not expected to change (i.e. in dose, frequency, additions or deletions of agents) for at least 2 weeks before ICG dye injection.

9. Must, in the Investigator's opinion, be able to comply with study procedures.

10. If the Subject is being enrolled in the fifth group they have a diagnosis of acute liver failure (ALF) as defined by the Principal Investigator.

Exclusion Criteria:

1. Have any clinically significant condition or unstable current illness that would, in the opinion of the Investigator, preclude study participation or interfere with the assessment of the procedure;

2. Known allergy or sensitivity to ICG dye or history of allergy to iodides;

3. Actively bleeding associated with acute blood volume changes.