NCT04577001

Letrozole in Patients With Hepatopulmonary Syndrome

Letrozole in Patients With Hepatopulmonary Syndrome: A Double-Blind Randomized Clinical Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Hepatopulmonary Syndrome

Interventions

Type	Name	Description
DRUG	Letrozole	2.5 mg orally daily for 6 months
DRUG	Placebo	No active ingredient taken orally daily for 6 months

Timeline

• Start date: 2021-02-18
• Primary completion: 2021-03-26
• Completion: 2021-03-26
• First posted: 2020-10-06
• Last updated: 2024-05-14
• Results posted: 2024-05-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study