Letrozole in Patients With Hepatopulmonary Syndrome

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-18

Study Completion Date

2021-03-26

Brief Summary

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The purpose of this study is to assess the safety, tolerability and possible benefit of letrozole compared to placebo in patients with Hepatopulmonary Syndrome.

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Detailed Description

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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

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Hepatopulmonary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Letrozole Group

Subjects with hepatopulmonary syndrome will get the study drug letrozole

Group Type EXPERIMENTAL

Letrozole

Intervention Type DRUG

2.5 mg orally daily for 6 months

Placebo Group

Subjects with hepatopulmonary syndrome will get the study placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

No active ingredient taken orally daily for 6 months

Interventions

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Letrozole

2.5 mg orally daily for 6 months

Intervention Type DRUG

Placebo

No active ingredient taken orally daily for 6 months

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No