A Study to Evaluate Letrozole in Patients with Hepatopulmonary Syndrome

Overview

About this study

The purpose of this study is to determine whether letrozole affects alveolar-arterial oxygen gradient (AaPO2) at 6 months in patients with hepatopulmonary syndrome (HPS).

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 10/18/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Hilary DuBrock, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

Non-cancer trials contact form

Phone: 800-664-4542 (toll-free)

International patient clinical studies questions