Letrozole in Patients With Hepatopulmonary Syndrome

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety, tolerability and possible benefit of letrozole compared to placebo in patients with Hepatopulmonary Syndrome.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: University of California, San Francisco
• Treatments: Letrozole

Criteria

Inclusion Criteria

• Diagnosis of moderate to very severe hepatopulmonary syndrome which consists of having all 3 of the following conditions:

• Presence of liver disease or portal hypertension

• Intrapulmonary shunting on contrast-enhanced echocardiogram

• Hypoxemia [A-a gradient ≥15mmHg (or ≥20mmHg if age >64) and PaO2<80mmHg on arterial blood gas testing]

• Child-Pugh class A or B liver disease

• MELD score < 20

• ≥ 18 years old

• Female subjects must be post-menopausal (defined as 12 months of spontaneous amenorrhea or 6 weeks postsurgical bilateral oophorectomy without or without hysterectomy)

• Ability to provide informed consent

Exclusion Criteria

• Enrollment in a clinical trial or concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 28 days of baseline

• Current hepatic encephalopathy

• Expectation of liver transplant within six months of randomization

• MELD exception score > 28

• Concomitant lung disease defined as restriction (TLC < 70%) or obstruction (FEV1 < 80% & FEV1/FVC < 70%)

• Inability to comply with the study protocol

• Osteoporosis

• Premenopausal women (those who have not reached 1 year absence of menarche)

• Vulnerable study population, including imprisoned individuals, non-English speaking patients