Not provided
Not provided
Not provided
Not provided
Not provided
Low Recruitment Numbers
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the safety, tolerability and possible benefit of letrozole compared to placebo in patients with Hepatopulmonary Syndrome.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letrozole Group | Experimental | Subjects with hepatopulmonary syndrome will get the study drug letrozole |
|
| Placebo Group | Placebo Comparator | Subjects with hepatopulmonary syndrome will get the study placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole | Drug | 2.5 mg orally daily for 6 months |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Alveolar-Arterial Oxygen | To determine whether letrozole affects alveolar-arterial oxygen gradient (AaPO2) at 6 months in patients with HPS. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hormone Levels | To determine whether letrozole affects estradiol, progesterone, testosterone levels at 6 months | 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 |
Not provided
Inclusion Criteria
Diagnosis of moderate to very severe hepatopulmonary syndrome which consists of having all 3 of the following conditions:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hilary M DuBrock, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Letrozole Group | Subjects with hepatopulmonary syndrome will get the study drug letrozole Letrozole: 2.5 mg orally daily for 6 months |
| FG001 | Placebo Group | Subjects with hepatopulmonary syndrome will get the study placebo Placebo: No active ingredient taken orally daily for 6 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Study terminated due to low recruitment numbers. No subjects were enrolled in the Letrozole group.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Letrozole Group | Subjects with hepatopulmonary syndrome will get the study drug letrozole Letrozole: 2.5 mg orally daily for 6 months |
| BG001 | Placebo Group | Subjects with hepatopulmonary syndrome will get the study placebo Placebo: No active ingredient taken orally daily for 6 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Alveolar-Arterial Oxygen | To determine whether letrozole affects alveolar-arterial oxygen gradient (AaPO2) at 6 months in patients with HPS. | Study terminated due to low recruitment numbers. Data was not collected on the one enrolled participant for this outcome measure due to withdrawal after becoming ineligible prior to outcome measure timeframe completion. | Posted | 6 months |
|
Adverse events were collected from baseline to end of study participation for a total of 37 days.
Study terminated due to low recruitment numbers. No subjects were enrolled in the Letrozole group.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Letrozole Group | Subjects with hepatopulmonary syndrome will get the study drug letrozole Letrozole: 2.5 mg orally daily for 6 months |
Not provided
Not provided
Terminated study due to low recruitment numbers.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hilary DuBrock | Mayo Clinic | (507) 284-2957 | DuBrock.Hilary@mayo.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 11, 2021 | Mar 15, 2024 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020065 | Hepatopulmonary Syndrome |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
No active ingredient taken orally daily for 6 months |
|
| 3 and 6 months |
| Side Effects | To determine the safety and adverse effects associated with letrozole administration in patients with HPS | 6 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Hormone Levels | To determine whether letrozole affects estradiol, progesterone, testosterone levels at 6 months | Study terminated due to low recruitment numbers. Data was not collected on the one enrolled participant for this outcome measure due to withdrawal after becoming ineligible prior to outcome measure timeframe completion. | Posted | 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 | Study terminated due to low recruitment numbers. Data was not collected on the one enrolled participant for this outcome measure due to withdrawal after becoming ineligible prior to outcome measure timeframe completion. | Posted | 3 and 6 months |
|
|
| Secondary | Side Effects | To determine the safety and adverse effects associated with letrozole administration in patients with HPS | Study terminated due to low recruitment numbers. Data was not collected on the one enrolled participant for this outcome measure due to withdrawal after becoming ineligible prior to outcome measure timeframe completion. | Posted | 6 months |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo Group | Subjects with hepatopulmonary syndrome will get the study placebo Placebo: No active ingredient taken orally daily for 6 months | 0 | 1 | 0 | 1 | 0 | 1 |
Not provided
Not provided
Not provided
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |