Letrozole in Patients With Hepatopulmonary Syndrome

Phase 2

Terminated

• Conditions: Hepatopulmonary Syndrome
• Interventions: Drug: Placebo; Drug: Letrozole

• Registration Number: NCT04577001
• Lead Sponsor: Mayo Clinic

Brief 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.

Study Timeline

• Study First Submitted: 2020-09-30
• Study First Submitted QC: 2020-09-30
• Study First Posted: 2020-10-06
• Study Start: 2021-02-18
• Primary Completion: 2021-03-26
• Study Completion: 2021-03-26
• Results First Submitted: 2024-03-19
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-18
• Last Update Submitted: 2024-04-18
• Results First Posted: 2024-05-14
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	Subjects with hepatopulmonary syndrome will get the study placebo
Letrozole Group	Letrozole	Subjects with hepatopulmonary syndrome will get the study drug letrozole

Primary Outcome Measures

Name	Time	Method
Alveolar-Arterial Oxygen	6 months	To determine whether letrozole affects alveolar-arterial oxygen gradient (AaPO2) at 6 months in patients with HPS.

Secondary Outcome Measures

Name	Time	Method
Hormone Levels	6 months	To determine whether letrozole affects estradiol, progesterone, testosterone levels at 6 months
Oxygen Saturation	3 and 6 months	To determine whether letrozole affects oxygen saturation from pulse oximetry at 3 months 6 months and distance walked in 6 minutes in patients with HPS
Side Effects	6 months	To determine the safety and adverse effects associated with letrozole administration in patients with HPS

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States