Trial · NCT02021929

Sorafenib for Hepatopulmonary Syndrome

NCT02021929, Phase 2, Terminated, University of Pennsylvania; results first posted 2019-04-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Sorafenib for Hepatopulmonary Syndrome. Trials, record NCT02021929. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02021929

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Sorafenib for Hepatopulmonary Syndrome
NCT number: NCT02021929
Status: Terminated
Phases: Phase 2
Enrollment: 28 participants, actual
Lead sponsor: University of Pennsylvania
Conditions: Hepatopulmonary Syndrome
Interventions: Sorafenib, Placebo
First posted: 2013-12-27
Last updated: 2019-04-25
Results first posted: 2019-04-25
Limitations and caveats: Recruitment difficult due to challenges in screening for HPS, lack of patient awareness of HPS, and hesitation from potential subjects due to sorafenib side effects. Sample size reduced and sponsor terminated trial before reaching target sample size

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Alveolar-arterial Oxygen Gradient Between Sorafenib and Placebo Groups	Baseline to 12 weeks	Alveolar-arterial oxygen gradient is a calculated measure of oxygenation. It is the difference between the amount of the oxygen in the alveoli and the amount of oxygen in arterial blood. Calculation is based on values from an Arterial Blood Gas test. Difference in change in alveolar-arterial oxygen gradient between sorafenib and placebo from baseline to 12 weeks.
Secondary	Number of Participants With Improvement in Intrapulmonary Shunting From Baseline to 12 Weeks.	Baseline to 12 weeks	Intrapulmonary shunting is measured based on results from a saline-bubble echo test. Number of participants with measured improvement in intrapulmonary shunting from baseline to 12 weeks in the sorafenib and placebo groups
Secondary	Change From Baseline in Percentage of Progenitor Cells (Peripheral Blood Mononuclear Cells or PBMCs)	Baseline to 12 weeks	Progenitor Cells (Peripheral Blood Mononuclear Cells or PBMCs) are obtained and measured from blood samples collected from each participant. Difference in change from baseline to 12 weeks in the Percentage of Progenitor Cells between sorafenib and placebo groups.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Alveolar-arterial Oxygen Gradient Between Sorafenib and Placebo Groups	Baseline to 12 weeks		mm Hg	MEDIAN
SECONDARY	Number of Participants With Improvement in Intrapulmonary Shunting From Baseline to 12 Weeks.	Baseline to 12 weeks	Since all of the participants did not complete the 12 week study visit, data from fewer participants were available to be analyzed in each arm for this measure.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in Percentage of Progenitor Cells (Peripheral Blood Mononuclear Cells or PBMCs)	Baseline to 12 weeks	Since all of the participants did not complete the 12 week study visit, data from fewer participants were available to be analyzed in each arm for this measure.	percentage of PBMCs	MEDIAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Alveolar-arterial Oxygen Gradient Between Sorafenib and Placebo Groups	Sorafenib	4.5	Inter-Quartile Range -3.8 to 7.0	mm Hg
Change in Alveolar-arterial Oxygen Gradient Between Sorafenib and Placebo Groups	Placebo	-2.4	Inter-Quartile Range -4.8 to 8.2	mm Hg
Number of Participants With Improvement in Intrapulmonary Shunting From Baseline to 12 Weeks.	Sorafenib	3		Participants
Number of Participants With Improvement in Intrapulmonary Shunting From Baseline to 12 Weeks.	Placebo	6		Participants
Change From Baseline in Percentage of Progenitor Cells (Peripheral Blood Mononuclear Cells or PBMCs)	Sorafenib	0.01	Inter-Quartile Range -0.02 to 0.04	percentage of PBMCs
Change From Baseline in Percentage of Progenitor Cells (Peripheral Blood Mononuclear Cells or PBMCs)	Placebo	0.04	Inter-Quartile Range 0.00 to 0.07	percentage of PBMCs

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Sorafenib	16
Overall Study	STARTED	Placebo	12
Overall Study	COMPLETED	Sorafenib	14
Overall Study	COMPLETED	Placebo	11
Overall Study	NOT COMPLETED	Sorafenib	2
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events52

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhea	Gastrointestinal disorders	Sorafenib	5	16
other	Diarrhea	Gastrointestinal disorders	Placebo	4	12
other	Abdominal pain	Gastrointestinal disorders	Sorafenib	2	16
other	Abdominal pain	Gastrointestinal disorders	Placebo	5	12
other	Weight loss	General disorders	Sorafenib	5	16
other	Weight loss	General disorders	Placebo	2	12
other	Fatigue	General disorders	Sorafenib	3	16
other	Fatigue	General disorders	Placebo	3	12
other	Nausea	Gastrointestinal disorders	Sorafenib	3	16
other	Nausea	Gastrointestinal disorders	Placebo	3	12

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sorafenib	1	16
Total, all-cause mortality	Placebo	0	12
Total, other adverse events	Sorafenib	16	16
Total, other adverse events	Placebo	12	12
Total, serious adverse events	Sorafenib	7	16
Total, serious adverse events	Placebo	5	12

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
UM1HL116886	Sorafenib for Hepatopulmonary Syndrome	KAWUT, STEVEN M; FALLON, MICHAEL B	UNIVERSITY OF PENNSYLVANIA	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2013 to 2015

Source NIH RePORTER

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Sorafenib vs Placebo: Number of Participants With Improvement in Intrapulmonary Shunting From Baseline to 12 Weeks.	Trial comparisons
Sorafenib vs Placebo: deaths from any cause	Trial comparisons
Sorafenib vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02021929

GET https://conductscience.org/api/trials/v1/NCT02021929/events?page=2

API reference For AI assistants