| Eligibility |
Inclusion Criteria:
1. Male = 18 years old
2. Currently listed, on the liver transplant waitlist for cirrhosis secondary to
Hepatitis B or C infection, Alcoholic Liver Disease (ALD), Non-Alcoholic
Steatohepatitis (NASH), Primary Biliary Cholangitis (PBC), or Primary Sclerosing
Cholangitis (PSC)
3. Evidence of sarcopenia with appropriate cutoff recommended by clinical guidance
Exclusion Criteria:
1. Suspected or proven hepatocellular carcinoma (HCC)
2. History of current or suspected prostate or breast cancer
3. History of malignancies other than prostate, breast, or HCC, unless successfully
treated with curative intent and believed to be cured (defined as complete remission
lasting at least 5 years)
4. History of uncontrolled or recurrent portal hypertensive bleeding, including
uncontrolled or recurrent bleeding from varices, gastropathy, colopathy, or
hemorrhoidal bleeding in the past 6 months.
5. History or current thrombosis (including portal vein thrombosis), thromboembolism, or
treatment for portal vein thrombosis
6. History of hemochromatosis
7. History of hypercoagulable state (e.g. Factor V Leiden deficiency, protein C
deficiency, protein S deficiency, anti-thrombin III deficiency, or the presence of
lupus anticoagulant)
8. Prior history of complications of ascites in the past 6 months including:
1. Spontaneous bacterial peritonitis
2. Hepatic hydrothorax
9. MELD score > 25
10. Abnormal lab value in serum chemistry, hematology, or urinalysis that the PI considers
clinically significant, including but not limited to:
1. PSA > 4 ng/mL
2. Polycythemia (Hematocrit > ULN) or history of polycythemia
3. ALT or AST > 5x ULN
4. ALP > 2x ULN; subjects with PBC or PSC are excluded if ALP is > 10x ULN
5. Platelet count < 30,000/mL
6. EGFR < 30 mL/min/1.73 m2 for subjects not undergoing routine, scheduled dialysis
7. Serum albumin < 2.0 g/dL
8. INR > 2.3
11. Subjects with PSA between 2.5 ng/mL and 4 ng/mL are excluded only if any of the below
criteria are met at baseline:
1. Hematocrit > 48%
2. I-PSS > 19
3. Any irregularity found on digital rectal examination of the prostate
12. Subjects with PSA > 3 ng/mL are excluded only if any of the below criteria are met at
baseline:
1. Subject is African American
2. Subject has a first-degree relative who has a history of prostate cancer
3. Hematocrit > 48%
4. I-PSS > 19
5. Any irregularity found on digital rectal examination of the prostate
13. Clinically significant abnormal prostate digital rectal examination (DRE) in the
opinion of the PI, with DRE screening initiated at International Prostate Symptom
Score (I-PSS) > 19
14. History of bariatric surgery
15. History of stroke or myocardial infarction within the past 5 years
16. History of TIPS within the past 6 months, or TIPS procedure expected within 6 months
of Day 1
17. Known positivity for Human Immunodeficiency Virus (HIV) infection
18. Acute liver failure as the indication for addition to the liver transplant waitlist
19. Estimated life expectancy less than 3 months or expected to undergo liver transplant
within 3 months
20. Known heart failure of New York Heart Association class III or IV
21. Evidence of severe encephalopathy at screening encephalopathy that is not controlled
despite adequate medical therapy
22. History of prior organ transplant
23. History of Fontan physiology
24. History of pulmonary embolus
25. Porto-pulmonary hypertension
26. Hepatopulmonary syndrome requiring standing home supplemental oxygen therapy, or MELD
exception points for hepatopulmonary syndrome
27. Uncontrolled epilepsy or migraine
28. Active substance abuse or dependency extending to within the previous 3 months
29. History of significant sensitivity or allergy to testosterone, or product excipients.
30. Use of known strong inhibitors (e.g., ketoconazole) or inducers (e.g., dexamethasone,
phenytoin, rifampin, carbamazepine) of cytochrome P450 3A (CYP3A) within 30 days prior
to study drug administration and through the end of the study
31. Subjects who are currently receiving any androgens (testosterone or other androgens or
androgen-containing supplements) and are unwilling to washout prior to screening
a. Washout: 12 weeks following long-acting intramuscular androgen injections; 4 weeks
following topical or buccal androgens; 3 weeks following oral androgens
32. Uncontrolled hypertension (>160/90 mmHg despite treatment)
33. Uncontrolled obstructive sleep apnea
34. Use of any investigational drug within 5 half-lives of the last dose or in the past 6
months prior to Study Day -2 without medical monitor and/or Sponsor approval
35. Subject who is not willing to use adequate contraception for the duration of the study
36. Any other condition, which in the opinion of the investigator would impede compliance
to the study protocol (including diet, exercise, and alcohol abstinence) or hinder
completion of the study
37. Failure to give informed consent
|
