Letrozole in Patients With Hepatopulmonary Syndrome

Hepatopulmonary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04577001
• Other study ID #: 19-005779
• Status: Terminated
• Phase: Phase 2
• Start date: February 18, 2021
• Est. completion date: March 26, 2021

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 26, 2021
• Est. primary completion date: March 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

• 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, or those who cannot consent on their own.

Related Conditions & MeSH terms

• Hepatopulmonary Syndrome
• Syndrome

Intervention

Drug:
• Letrozole
2.5 mg orally daily for 6 months
• Placebo
No active ingredient taken orally daily for 6 months

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alveolar-Arterial Oxygen	To determine whether letrozole affects alveolar-arterial oxygen gradient (AaPO2) at 6 months in patients with HPS.	6 months
Secondary	Hormone Levels	To determine whether letrozole affects estradiol, progesterone, testosterone levels at 6 months	6 months
Secondary	Oxygen Saturation	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	3 and 6 months
Secondary	Side Effects	To determine the safety and adverse effects associated with letrozole administration in patients with HPS	6 months