Trial Outcomes & Findings for Letrozole in Patients With Hepatopulmonary Syndrome (NCT NCT04577001)

NCT ID: NCT04577001

Last Updated: 2024-05-14

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2024-05-14

Participant Flow

Participant milestones

Measure	Letrozole Group Subjects with hepatopulmonary syndrome will get the study drug letrozole Letrozole: 2.5 mg orally daily for 6 months	Placebo Group Subjects with hepatopulmonary syndrome will get the study placebo Placebo: No active ingredient taken orally daily for 6 months
Overall Study STARTED	0	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Letrozole Group Subjects with hepatopulmonary syndrome will get the study drug letrozole Letrozole: 2.5 mg orally daily for 6 months	Placebo Group Subjects with hepatopulmonary syndrome will get the study placebo Placebo: No active ingredient taken orally daily for 6 months
Overall Study Subject became ineligible	0	1

Baseline Characteristics

Letrozole in Patients With Hepatopulmonary Syndrome

Baseline characteristics by cohort

Measure	Letrozole Group Subjects with hepatopulmonary syndrome will get the study drug letrozole Letrozole: 2.5 mg orally daily for 6 months	Placebo Group n=1 Participants Subjects with hepatopulmonary syndrome will get the study placebo Placebo: No active ingredient taken orally daily for 6 months	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	—	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: 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.

To determine whether letrozole affects estradiol, progesterone, testosterone levels at 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 and 6 months

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: 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.

To determine the safety and adverse effects associated with letrozole administration in patients with HPS

Outcome measures

Outcome data not reported

Adverse Events

Letrozole Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Hilary DuBrock

Mayo Clinic

Phone: (507) 284-2957

Email: DuBrock.Hilary@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place