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Letrozole in Patients With Hepatopulmonary Syndrome

Primary Purpose

Hepatopulmonary Syndrome

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Letrozole
Placebo
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatopulmonary Syndrome

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • 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

Sites / Locations

  • University of California San FranciscoRecruiting
  • Mayo ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Letrozole Group

Placebo Group

Arm Description

Subjects with hepatopulmonary syndrome will get the study drug letrozole

Subjects with hepatopulmonary syndrome will get the study placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hormone Levels
To determine whether letrozole affects estradiol, progesterone, testosterone levels at 6 months
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
Side effects
• To determine the safety and adverse effects associated with letrozole administration in patients with HPS

Full Information

First Posted
September 30, 2020
Last Updated
April 10, 2023
Sponsor
Mayo Clinic
Collaborators
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT04577001
Brief Title
Letrozole in Patients With Hepatopulmonary Syndrome
Official Title
Letrozole in Patients With Hepatopulmonary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatopulmonary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Letrozole Group
Arm Type
Experimental
Arm Description
Subjects with hepatopulmonary syndrome will get the study drug letrozole
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Subjects with hepatopulmonary syndrome will get the study placebo
Intervention Type
Drug
Intervention Name(s)
Letrozole
Intervention Description
2.5 mg orally daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
No active ingredient taken orally daily for 6 months
Primary Outcome Measure Information:
Title
Alveolar-Arterial Oxygen
Description
To determine whether letrozole affects alveolar-arterial oxygen gradient (AaPO2) at 6 months in patients with HPS.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Hormone Levels
Description
To determine whether letrozole affects estradiol, progesterone, testosterone levels at 6 months
Time Frame
6 months
Title
Oxygen Saturation
Description
• 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
Time Frame
3 and 6 months
Title
Side effects
Description
• To determine the safety and adverse effects associated with letrozole administration in patients with HPS
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jackie Reiter
Phone
(507) 538-2224
Email
Reiter.Jacqulyn@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilary M DuBrock, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvonne Kelly, M.D
Email
Yvonne.Kelly@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Yvonne Kelly, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jackie R Reiter
Phone
507-538-2224
Email
Reiter.Jacqulyn@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Letrozole in Patients With Hepatopulmonary Syndrome

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