Trial · NCT02770716
Study To Confirm Efficacy and Safety of Terlipressin in Hepatorenal Syndrome (HRS) Type 1
NCT02770716, Phase 3, Completed, Mallinckrodt; results first posted 2022-08-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study To Confirm Efficacy and Safety of Terlipressin in Hepatorenal Syndrome (HRS) Type 1. Trials, record NCT02770716. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02770716
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study To Confirm Efficacy and Safety of Terlipressin in Hepatorenal Syndrome (HRS) Type 1
- NCT number
- NCT02770716
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 300 participants, actual
- Lead sponsor
- Mallinckrodt
- Conditions
- Hepatorenal Syndrome
- Interventions
- Terlipressin, Placebo
- First posted
- 2016-05-12
- Last updated
- 2022-11-29
- Results first posted
- 2022-08-18
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Verified HRS Reversal | within 15 Days | Defined as the percentage of participants with 2 consecutive SCr values ≤ 1.5 mg/dL at least 2 hours apart, while on treatment by Day 14 or discharge (on treatment defined as up to 24 hours after the final dose of study drug), per protocol. |
| Primary | Percentage of Participants Who Were Viable (Per Protocol) for Inclusion in the Primary End Point Analysis | within 25 days | Defined as the percentage of participants with verified HRS reversal who lived at least 10 days without RRT, and were otherwise viable (per protocol) for inclusion in the primary endpoint analysis |
| Secondary | Percentage of Participants With HRS Reversal | within 14 days | Defined as the percentage of participants with a SCr value no more than 1.5 mg/dL by Day 14 or discharge, and were viable (per protocol) for inclusion in the secondary endpoint analysis |
| Secondary | Percentage of Participants With Durable HRS Reversal | Day 30 | Defined as the percentage of participants maintaining HRS reversal without RRT to Day 30 |
| Secondary | Percentage pf Participants in the SIRS Subgroup With HRS Reversal | within 14 days | Defined as the percentage of participants in the SIRS subgroup with HRS reversal by Day 14 or discharge |
| Secondary | Percentage of Participants With Verified HRS Reversal Without HRS Recurrence by Day 30 | Day 30 | Defined as the percentage of participants who had achieved verified HRS reversal by Day 15 or discharge and did not revert to baseline measures by day 30 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Verified HRS Reversal | within 15 Days | ITT | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Were Viable (Per Protocol) for Inclusion in the Primary End Point Analysis | within 25 days | ITT | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HRS Reversal | within 14 days | ITT | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Durable HRS Reversal | Day 30 | ITT | percentage of participants | NUMBER |
| SECONDARY | Percentage pf Participants in the SIRS Subgroup With HRS Reversal | within 14 days | ITT participants in the SIRS subgroup | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Verified HRS Reversal Without HRS Recurrence by Day 30 | Day 30 | ITT | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Verified HRS Reversal | Terlipressin | 29.1 | percentage of participants | ||
| Percentage of Participants With Verified HRS Reversal | Placebo | 15.8 | percentage of participants | ||
| Percentage of Participants Who Were Viable (Per Protocol) for Inclusion in the Primary End Point Analysis | Terlipressin | 91.3 | percentage of participants | ||
| Percentage of Participants Who Were Viable (Per Protocol) for Inclusion in the Primary End Point Analysis | Placebo | 94.4 | percentage of participants | ||
| Percentage of Participants With HRS Reversal | Terlipressin | 36.2 | percentage of participants | ||
| Percentage of Participants With HRS Reversal | Placebo | 16.8 | percentage of participants | ||
| Percentage of Participants With Durable HRS Reversal | Terlipressin | 31.7 | percentage of participants | ||
| Percentage of Participants With Durable HRS Reversal | Placebo | 15.8 | percentage of participants | ||
| Percentage pf Participants in the SIRS Subgroup With HRS Reversal | Terlipressin | 33.3 | percentage of participants | ||
| Percentage pf Participants in the SIRS Subgroup With HRS Reversal | Placebo | 6.3 | percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Terlipressin | 199 | |
| Overall Study | STARTED | Placebo | 101 | |
| Overall Study | Intent to Treat (ITT) | Terlipressin | 199 | |
| Overall Study | Intent to Treat (ITT) | Placebo | 101 | |
| Overall Study | Safety Analysis Set (SAS) | Terlipressin | 200 | |
| Overall Study | Safety Analysis Set (SAS) | Placebo | 99 | |
| Overall Study | Systemic Inflammatory Response Syndrome (SIRS) Subgroup | Terlipressin | 84 | |
| Overall Study | Systemic Inflammatory Response Syndrome (SIRS) Subgroup | Placebo | 48 | |
| Overall Study | COMPLETED | Terlipressin | 87 | |
| Overall Study | COMPLETED | Placebo | 52 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events244
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 | Terlipressin | 13 | 200 | 14 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 6 | 99 | 6 |
| other | Bradycardia | Cardiac disorders | Terlipressin | 10 | 200 | 11 |
| other | Bradycardia | Cardiac disorders | Placebo | 0 | 99 | 0 |
| other | Tachycardia | Cardiac disorders | Terlipressin | 10 | 200 | 10 |
| other | Tachycardia | Cardiac disorders | Placebo | 8 | 99 | 9 |
| other | Abdominal pain | Gastrointestinal disorders | Terlipressin | 38 | 200 | 46 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 5 | 99 | 5 |
| other | Ascites | Gastrointestinal disorders | Terlipressin | 10 | 200 | 10 |
| other | Ascites | Gastrointestinal disorders | Placebo | 3 | 99 | 3 |
1 to 10 of 244Source ClinicalTrials.gov
See all 244 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Terlipressin | 101 | 200 |
| Total, all-cause mortality | Placebo | 45 | 99 |
| Total, other adverse events | Terlipressin | 157 | 200 |
| Total, other adverse events | Placebo | 82 | 99 |
| Total, serious adverse events | Terlipressin | 142 | 200 |
| Total, serious adverse events | Placebo | 62 | 99 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Terlipressin vs Placebo: deaths from any cause | Trial comparisons |
| Terlipressin 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/NCT02770716
GET https://conductscience.org/api/trials/v1/NCT02770716/events?page=2