Trial · NCT05161481
A Study to Test Whether Two Different Doses of Avenciguat Help People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver)
NCT05161481, Phase 2, Terminated, Boehringer Ingelheim; results first posted 2025-06-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Test Whether Two Different Doses of Avenciguat Help People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver). Trials, record NCT05161481. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05161481
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Test Whether Two Different Doses of Avenciguat Help People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver)
- NCT number
- NCT05161481
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 80 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Hypertension, Portal
- Interventions
- Avenciguat (BI 685509), Placebo matching Avenciguat (BI 685509)
- First posted
- 2021-12-17
- Last updated
- 2025-09-03
- Other registries' IDs
- eudract:2021-001285-38
- Results first posted
- 2025-06-15
- Limitations and caveats
This trial was discontinued after Boehringer Ingelheim ended Avenciguat's clinical development for CSPH due to lack of efficacy, not safety concerns. Enrollment was complete, but some patients were still in treatment. These patients were asked to stop trial medication and attend an Early Discontinuation Visit, then entered the follow-up period per the clinical trial protocol.
Source ClinicalTrials.gov
Registered outcomes9
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 After 24 Weeks of Treatment | From first administration of trial medication up to 24 weeks. | HVPG was calculated as the difference between the average wedged hepatic venous pressure (WHVP) and either: Proximal Free Hepatic Venous Pressure (PFHVP), if judged more reliable, or Average Free Hepatic Venous Pressure (FHVP), if considered more reliable. Based on the central reader's judgment: If PFHVP was more reliable: HVPG(mmHg)= Average WHVP (mmHg) - PFHVP (mmHg) If FHVP was more reliable: HVPG(mmHg)=Average WHVP (mmHg)-Average FHVP (mmHg) Percentage Change = (HVPG at 24 weeks- Baseline HVPG/Baseline HVPG) × 100 A restricted maximum likelihood (REML) approach using a mixed model with repeated measurements (MMRM) was used to estimate adjusted treatment means. The analysis included fixed categorical effects for treatment at each visit, use of non-selective beta-blockers (NSBBs) or carvedilol at baseline (yes/no), and fixed continuous effects for baseline hepatic venous pressure gradient (HVPG) at each visit. |
| Secondary | Percentage Change in Hepatic Venous Pressure Gradient (HVPG) From Baseline, Measured in Millimeters of Mercury (mmHg), After 8 Weeks of Treatment | From first administration of trial medication up to 8 weeks. | HVPG was calculated as the difference between the average wedged hepatic venous pressure (WHVP) and either: Proximal Free Hepatic Venous Pressure (PFHVP), if judged more reliable. Average Free Hepatic Venous Pressure (FHVP), if considered more reliable. Based on the central reader's judgment: If PFHVP was more reliable: HVPG(mmHg)= Average WHVP (mmHg) - PFHVP (mmHg) If FHVP was more reliable: HVPG(mmHg)=Average WHVP (mmHg)-Average FHVP (mmHg) Percentage Change = (HVPG at 8 weeks- Baseline HVPG/Baseline HVPG) × 100 This endpoint was analyzed using the Treatment Policy Estimand and an ANCOVA model. The model included baseline HVPG as a linear covariate, and treatment and use of non-selective beta-blockers (NSBBs) or carvedilol as fixed effects. |
| Secondary | Response Defined as > 10% Reduction From Baseline HVPG (Measured in mmHg) After 8 Weeks of Treatment | From first administration of trial medication up to 8 weeks. | Response is defined as greater than 10% reduction from baseline HVPG (measured in mmHg) after 8 weeks of treatment. The number of participants with, or without response after 8 weeks of treatment with Avenciguat is reported. |
| Secondary | Response Defined as > 10% Reduction From Baseline HVPG (Measured in mmHg) After 24 Weeks of Treatment | From first administration of trial medication up to 24 weeks. | Response is defined as greater than 10% reduction from baseline HVPG (measured in mmHg) after 24 weeks of treatment. |
| Secondary | Occurrence of One or More Decompensation Events (i.e. Ascites, VH, and / or Overt HE) During the 24 Week Treatment Period | From first administration of trial medication up to 24 weeks. | A decompensation event is characterized by the occurrence of any of the following: * Ascites, * Variceal hemorrhage, * Overt hepatic encephalopathy. |
| Secondary | Occurrence of CTCAE Grade 3 (or Higher) Hypotension or Syncope Based on Investigator Judgement, During the First 8 Weeks of the Treatment Period | From first administration of trial medication up to 8 weeks. | The occurrence of CTCAE grade 3 (or higher) hypotension or syncope, based on the investigator's judgment, during the first 8 weeks of the treatment period is reported. |
| Secondary | Occurrence of CTCAE Grade 3 (or Higher) Hypotension or Syncope Based on Investigator Judgement, During the 24 Week Treatment Period | From first administration of trial medication up to 24 weeks. | The occurrence of CTCAE grade 3 (or higher) hypotension or syncope, based on the investigator's judgment, during the 24 weeks of the treatment period is reported. |
| Secondary | Occurrence of Discontinuation Due to Hypotension or Syncope During the First 8 Weeks of the Treatment Period | From first administration of trial medication up to 8 weeks. | The occurrence of hypotension or syncope during the first 8 weeks of the treatment period leading to the participant's discontinuation is reported. |
| Secondary | Occurrence of Discontinuation Due to Hypotension or Syncope During the 24 Week Treatment Period | From first administration of trial medication up to 24 weeks. | The occurrence of hypotension or syncope during the first 24 weeks of the treatment period leading to the participant's discontinuation is reported. |
Source ClinicalTrials.gov
Outcomes9
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 After 24 Weeks of Treatment | From first administration of trial medication up to 24 weeks. | Full analysis set (FAS) - this analysis set includes all randomised patients who received at least one dose of trial medication and have a baseline measurement for the primary endpoint recorded.~The hypothetical strategy was used for handling intercurrent events for the primary objective as a main analysis as if all the intercurrent events had not happened. | Percentage of change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change in Hepatic Venous Pressure Gradient (HVPG) From Baseline, Measured in Millimeters of Mercury (mmHg), After 8 Weeks of Treatment | From first administration of trial medication up to 8 weeks. | Full analysis set (FAS) - this analysis set includes all randomised patients who received at least one dose of trial medication and have a baseline measurement for the primary endpoint recorded.~All intercurrent events (ICEs) were handled using the treatment policy for the secondary endpoints. That is, all data collected after the intercurrent events will be included in the analysis. | Percentage of change | LEAST_SQUARES_MEAN |
| SECONDARY | Response Defined as > 10% Reduction From Baseline HVPG (Measured in mmHg) After 8 Weeks of Treatment | From first administration of trial medication up to 8 weeks. | Full analysis set (FAS) - this analysis set includes all randomised patients who received at least one dose of trial medication and have a baseline measurement for the primary endpoint recorded. If a patient misses the Week 8 visit, the missing data was not imputed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Response Defined as > 10% Reduction From Baseline HVPG (Measured in mmHg) After 24 Weeks of Treatment | From first administration of trial medication up to 24 weeks. | Full analysis set (FAS) - this analysis set includes all randomised patients who received at least one dose of trial medication and have a baseline measurement for the primary endpoint recorded. If a patient misses the Week 24 visit, the missing data was not imputed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Occurrence of One or More Decompensation Events (i.e. Ascites, VH, and / or Overt HE) During the 24 Week Treatment Period | From first administration of trial medication up to 24 weeks. | Treated set (TS) - the treated set includes all patients who were randomised 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 First 8 Weeks of the Treatment Period | From first administration of trial medication up to 8 weeks. | Treated set (TS) - the treated set includes all patients who were randomised 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 24 Week Treatment Period | From first administration of trial medication up to 24 weeks. | Treated set (TS) - the treated set includes all patients who were randomised 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 First 8 Weeks of the Treatment Period | From first administration of trial medication up to 8 weeks. | Treated set (TS) - the treated set includes all patients who were randomised 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 24 Week Treatment Period | From first administration of trial medication up to 24 weeks. | Treated set (TS) - the treated set includes all patients who were randomised to the trial medication and were treated with at least one dose. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Change in Hepatic Venous Pressure Gradient (HVPG) From Baseline After 24 Weeks of Treatment | Placebo | 7.07 | 95% Confidence Interval -6.07 to 20.21 | Percentage of change | |
| Percentage Change in Hepatic Venous Pressure Gradient (HVPG) From Baseline After 24 Weeks of Treatment | Avenciguat 2 mg BID | -1.33 | 95% Confidence Interval -13.41 to 10.75 | Percentage of change | |
| Percentage Change in Hepatic Venous Pressure Gradient (HVPG) From Baseline After 24 Weeks of Treatment | Avenciguat 3 mg BID | -7.11 | 95% Confidence Interval -22.02 to 7.80 | Percentage of change | |
| Percentage Change in Hepatic Venous Pressure Gradient (HVPG) From Baseline, Measured in Millimeters of Mercury (mmHg), After 8 Weeks of Treatment | Placebo | -5.41 | 95% Confidence Interval -14.30 to 3.47 | Percentage of change | |
| Percentage Change in Hepatic Venous Pressure Gradient (HVPG) From Baseline, Measured in Millimeters of Mercury (mmHg), After 8 Weeks of Treatment | Avenciguat 2 mg BID | -1.90 | 95% Confidence Interval -10.62 to 6.82 | Percentage of change | |
| Percentage Change in Hepatic Venous Pressure Gradient (HVPG) From Baseline, Measured in Millimeters of Mercury (mmHg), After 8 Weeks of Treatment | Avenciguat 3 mg BID | -2.72 | 95% Confidence Interval -13.03 to 7.59 | Percentage of change | |
| Response Defined as > 10% Reduction From Baseline HVPG (Measured in mmHg) After 8 Weeks of Treatment | Placebo | Yes | 10 | Participants | |
| Response Defined as > 10% Reduction From Baseline HVPG (Measured in mmHg) After 8 Weeks of Treatment | Avenciguat 2 mg BID | Yes | 10 | Participants | |
| Response Defined as > 10% Reduction From Baseline HVPG (Measured in mmHg) After 8 Weeks of Treatment | Avenciguat 3 mg BID | Yes | 7 | Participants | |
| Response Defined as > 10% Reduction From Baseline HVPG (Measured in mmHg) After 8 Weeks of Treatment | Placebo | No | 14 | Participants |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 26 | |
| Overall Study | STARTED | Avenciguat 2 mg BID | 27 | |
| Overall Study | STARTED | Avenciguat 3 mg BID | 27 | |
| Overall Study | Treated | Placebo | 25 | |
| Overall Study | Treated | Avenciguat 2 mg BID | 27 | |
| Overall Study | Treated | Avenciguat 3 mg BID | 27 | |
| Overall Study | COMPLETED | Placebo | 19 | |
| Overall Study | COMPLETED | Avenciguat 2 mg BID | 23 | |
| Overall Study | COMPLETED | Avenciguat 3 mg BID | 17 | |
| Overall Study | NOT COMPLETED | Placebo | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events60
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 | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 25 | |
| other | Anaemia | Blood and lymphatic system disorders | Avenciguat 2mg BID | 2 | 27 | |
| other | Anaemia | Blood and lymphatic system disorders | Avenciguat 3mg BID | 0 | 27 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 1 | 25 | |
| other | Abdominal distension | Gastrointestinal disorders | Avenciguat 2mg BID | 2 | 27 | |
| other | Abdominal distension | Gastrointestinal disorders | Avenciguat 3mg BID | 0 | 27 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 2 | 25 | |
| other | Constipation | Gastrointestinal disorders | Avenciguat 2mg BID | 0 | 27 | |
| other | Constipation | Gastrointestinal disorders | Avenciguat 3mg BID | 0 | 27 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 25 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 25 |
| Total, all-cause mortality | Avenciguat 2mg BID | 0 | 27 |
| Total, all-cause mortality | Avenciguat 3mg BID | 0 | 27 |
| Total, other adverse events | Placebo | 9 | 25 |
| Total, other adverse events | Avenciguat 2mg BID | 10 | 27 |
| Total, other adverse events | Avenciguat 3mg BID | 11 | 27 |
| Total, serious adverse events | Placebo | 4 | 25 |
| Total, serious adverse events | Avenciguat 2mg BID | 1 | 27 |
| Total, serious adverse events | Avenciguat 3mg BID | 3 | 27 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37095557 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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GET https://conductscience.org/api/trials/v1/NCT05161481
GET https://conductscience.org/api/trials/v1/NCT05161481/results?page=2