Summary

Eligibility
for people ages 18-99 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

Details

This study is a phase II randomized, double-blind, placebo-controlled parallel trial of 20 subjects with hepatopulmonary syndrome designed to assess the effect of letrozole 2.5 mg orally daily or placebo for 6 months on the alveolar-arterial oxygen gradient (AaPO2).

Subjects at each site will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained baseline values will be established and subjects will begin letrozole with follow-up clinic visits and testing at 3 months, and 6 months.

Keywords

Hepatopulmonary Syndrome Syndrome Letrozole

Eligibility

You can join if…

Open to people ages 18-99

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California San Francisco
    San Francisco California 94143 United States
  • Mayo Clinic
    Rochester Minnesota 55902 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Mayo Clinic
Links
Mayo Clinic Clinical Trials
ID
NCT04577001
Phase
Phase 2
Study Type
Interventional
Last Updated