Trial · NCT06082843
A Study to Test Whether Avenciguat Helps People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver) Who Had Bleeding in the Esophagus or Fluid Accumulation in the Belly
NCT06082843, Phase 2, Terminated, Boehringer Ingelheim; results first posted 2025-06-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Test Whether Avenciguat Helps People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver) Who Had Bleeding in the Esophagus or Fluid Accumulation in the Belly. Trials, record NCT06082843. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06082843
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Test Whether Avenciguat Helps People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver) Who Had Bleeding in the Esophagus or Fluid Accumulation in the Belly
- NCT number
- NCT06082843
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Hypertension, Portal, Liver Cirrhosis
- Interventions
- Placebo, Avenciguat
- First posted
- 2023-10-13
- Last updated
- 2025-06-12
- Results first posted
- 2025-06-12
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change in Hepatic Venous Pressure Gradient (HVPG) From Baseline (Measured in mmHg) After 8 Weeks of Treatment | At baseline and at Week 8. | Percentage change in hepatic venous pressure gradient (HVPG) from baseline to Week 8. |
| Secondary | Occurrence of a Response, Defined as >10% Reduction From Baseline Hepatic Venous Pressure Gradient (HVPG) (Measured in mmHg) After 8 Weeks of Treatment | At baseline and at Week 8. | Occurrence of a response, defined as at least a 10% reduction in the hepatic venous pressure gradient (HVPG) (measured in mmHg) after 8 weeks of treatment. |
| Secondary | Occurrence of Further Decompensation Events (Ascites, Variceal Hemorrhage (VH), and / or Overt Hepatic Encephalopathy (HE)) During the 8-week Treatment Period | Up to 46 days. | Number of participants with at least one decompensation events. Ascites, variceal hemorrhage (VH), and hepatic encephalopathy were defined as further decompensations events. As the trial was discontinued prematurely and no patient completed the 8-week treatment period, the data presented reflects the actual on-treatment period. |
| Secondary | Occurrence of CTCAE Grade 3 (or Higher) Hypotension or Syncope Based on Investigator Judgement During the 8-week Treatment Period | Up to 46 days. | Number of participants with grade 3 or higher common terminology criteria for adverse events (CTCAE) hypotension or syncope base on the investigator judgment. As the trial was discontinued prematurely and no patient completed the 8-week treatment period, the data presented reflects the actual on-treatment period. |
| Secondary | Occurrence of Discontinuation Due to Hypotension or Syncope During the 8-week Treatment Period | Up to 46 days. | Number of participants that discontinued avenciguat due to hypotension or syncope. As the trial was discontinued prematurely and no patient completed the 8-week treatment period, the data presented reflects the actual on-treatment period. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Change in Hepatic Venous Pressure Gradient (HVPG) From Baseline (Measured in mmHg) After 8 Weeks of Treatment | At baseline and at Week 8. | As the trial was discontinued prematurely and no patient completed the 8-week treatment period, no data were available to assess the endpoint. | ||
| SECONDARY | Occurrence of a Response, Defined as >10% Reduction From Baseline Hepatic Venous Pressure Gradient (HVPG) (Measured in mmHg) After 8 Weeks of Treatment | At baseline and at Week 8. | As the trial was discontinued prematurely and no patient completed the 8-week treatment period, no data were available to assess the endpoint. | ||
| SECONDARY | Occurrence of Further Decompensation Events (Ascites, Variceal Hemorrhage (VH), and / or Overt Hepatic Encephalopathy (HE)) During the 8-week Treatment Period | Up to 46 days. | Treated set (TS): all trial participants who were randomized to the trial medication and were treated with at least one dose. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Occurrence of CTCAE Grade 3 (or Higher) Hypotension or Syncope Based on Investigator Judgement During the 8-week Treatment Period | Up to 46 days. | Treated set (TS): all trial participants who were randomized to the trial medication and were treated with at least one dose. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Occurrence of Discontinuation Due to Hypotension or Syncope During the 8-week Treatment Period | Up to 46 days. | Treated set (TS): all trial participants who were randomized to the trial medication and were treated with at least one dose. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Occurrence of Further Decompensation Events (Ascites, Variceal Hemorrhage (VH), and / or Overt Hepatic Encephalopathy (HE)) During the 8-week Treatment Period | Placebo | Ascites | 0 | Participants | |
| Occurrence of Further Decompensation Events (Ascites, Variceal Hemorrhage (VH), and / or Overt Hepatic Encephalopathy (HE)) During the 8-week Treatment Period | Avenciguat | Ascites | 0 | Participants | |
| Occurrence of Further Decompensation Events (Ascites, Variceal Hemorrhage (VH), and / or Overt Hepatic Encephalopathy (HE)) During the 8-week Treatment Period | Placebo | Variceal Hemorrhage | 0 | Participants | |
| Occurrence of Further Decompensation Events (Ascites, Variceal Hemorrhage (VH), and / or Overt Hepatic Encephalopathy (HE)) During the 8-week Treatment Period | Avenciguat | Variceal Hemorrhage | 0 | Participants | |
| Occurrence of Further Decompensation Events (Ascites, Variceal Hemorrhage (VH), and / or Overt Hepatic Encephalopathy (HE)) During the 8-week Treatment Period | Placebo | Hepatic encephalopathy | 0 | Participants | |
| Occurrence of Further Decompensation Events (Ascites, Variceal Hemorrhage (VH), and / or Overt Hepatic Encephalopathy (HE)) During the 8-week Treatment Period | Avenciguat | Hepatic encephalopathy | 0 | Participants | |
| Occurrence of CTCAE Grade 3 (or Higher) Hypotension or Syncope Based on Investigator Judgement During the 8-week Treatment Period | Placebo | 0 | Participants | ||
| Occurrence of CTCAE Grade 3 (or Higher) Hypotension or Syncope Based on Investigator Judgement During the 8-week Treatment Period | Avenciguat | 0 | Participants | ||
| Occurrence of Discontinuation Due to Hypotension or Syncope During the 8-week Treatment Period | Placebo | 0 | Participants | ||
| Occurrence of Discontinuation Due to Hypotension or Syncope During the 8-week Treatment Period | Avenciguat | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 12 | |
| Overall Study | STARTED | Avenciguat | 10 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | COMPLETED | Avenciguat | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 12 | |
| Overall Study | NOT COMPLETED | Avenciguat | 10 |
Source ClinicalTrials.gov
Adverse events16
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 | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 0 | 12 | |
| other | Abdominal distension | Gastrointestinal disorders | Avenciguat | 1 | 10 | |
| other | Hyperuricaemia | Metabolism and nutrition disorders | Placebo | 1 | 12 | |
| other | Hyperuricaemia | Metabolism and nutrition disorders | Avenciguat | 0 | 10 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 0 | 12 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Avenciguat | 1 | 10 | |
| other | Insomnia | Psychiatric disorders | Placebo | 1 | 12 | |
| other | Insomnia | Psychiatric disorders | Avenciguat | 0 | 10 | |
| other | Polyuria | Renal and urinary disorders | Placebo | 0 | 12 | |
| other | Polyuria | Renal and urinary disorders | Avenciguat | 1 | 10 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 12 |
| Total, all-cause mortality | Avenciguat | 0 | 10 |
| Total, other adverse events | Placebo | 1 | 12 |
| Total, other adverse events | Avenciguat | 3 | 10 |
| Total, serious adverse events | Placebo | 0 | 12 |
| Total, serious adverse events | Avenciguat | 2 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Avenciguat vs Placebo: Occurrence of Discontinuation Due to Hypotension or Syncope During the 8-week Treatment Period | Trial comparisons |
| Avenciguat vs Placebo: Occurrence of CTCAE Grade 3 (or Higher) Hypotension or Syncope Based on Investigator Judgement During the 8-week Treatment Period | Trial comparisons |
| Avenciguat vs Placebo: deaths from any cause | Trial comparisons |
| Avenciguat 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.
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/NCT06082843
GET https://conductscience.org/api/trials/v1/NCT06082843/registered