Hepatopulmonary SyndromePhase 2NCT04577001
Letrozole in Patients With Hepatopulmonary Syndrome
A Phase 2 study testing Letrozole in people with Hepatopulmonary Syndrome, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hepatopulmonary Syndrome
- What is being tested?
- Letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2021to 26 Mar 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- ≥ 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Letrozole in Patients With Hepatopulmonary Syndrome: A Double-Blind Randomized Clinical Trial
The purpose of this study is to assess the safety, tolerability and possible benefit of letrozole compared to placebo in patients with Hepatopulmonary Syndrome.
Read the 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.
- Conditions
- Hepatopulmonary Syndrome
- Being tested
- Letrozole, Placebo
- Medical subject headings
- Hepatopulmonary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
2.5 mg orally daily for 6 months
PlaceboDrug
No active ingredient taken orally daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Letrozole Group | Experimental | Subjects with hepatopulmonary syndrome will get the study drug letrozole Receives: Drug: Letrozole |
| Placebo Group | Placebo comparator | Subjects with hepatopulmonary syndrome will get the study placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar-Arterial Oxygen
To determine whether letrozole affects alveolar-arterial oxygen gradient (AaPO2) at 6 months in patients with HPS.
Measured: 6 months
Secondary outcomes (3)
Hormone Levels
To determine whether letrozole affects estradiol, progesterone, testosterone levels at 6 months
Measured: 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
Measured: 3 and 6 months
Side Effects
To determine the safety and adverse effects associated with letrozole administration in patients with HPS
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start18 Feb 2021
- Primary completion26 Mar 2021
- Study completion26 Mar 2021
Why it stopped: Low Recruitment Numbers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatopulmonary SyndromeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Principal investigator, Hilary M. DuBrock, MD, Mayo Clinic
- Investigators
- Hilary M DuBrock, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577001
- Sponsor's protocol ID
- 19-005779
- Status last verified
- Apr 2024
- First submitted
- 30 Sep 2020
- Last updated
- 14 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Letrozole in Patients With Hepatopulmonary Syndrome: A Double-Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04577001
- Acronym / sponsor ID
- 19-005779
- Conditions
- Hepatopulmonary Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Recruitment Numbers
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 26 Mar 2021 (actual)
- First posted
- 6 Oct 2020 (actual)
- Results
- Posted 14 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letrozole Group | Experimental | Drug: LetrozoleSubjects with hepatopulmonary syndrome will get the study drug letrozole |
| Placebo Group | Placebo comparator | Drug: PlaceboSubjects with hepatopulmonary syndrome will get the study placebo |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Letrozole2.5 mg orally daily for 6 months | Drug | Letrozole Group |
| PlaceboNo active ingredient taken orally daily for 6 months | Drug | Placebo Group |
Primary outcome
Alveolar-Arterial Oxygen
Time frame: 6 months
To determine whether letrozole affects alveolar-arterial oxygen gradient (AaPO2) at 6 months in patients with HPS.
3 secondary outcomes
Hormone Levels
Time frame: 6 months
Oxygen Saturation
Time frame: 3 and 6 months
Side Effects
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Hepatopulmonary Syndrome
Enrolling by invitationObservational study
International Registry of Congenital Portosystemic Shunt (IRCPSS)
Congenital Portosystemic Shunt, CPSS (Congenital Portosystemic Shunt)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilary M DuBrock, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Letrozole in people with Hepatopulmonary Syndrome, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alveolar-Arterial Oxygen (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.