Trial · NCT01143246
A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin
NCT01143246, Phase 3, Completed, Mallinckrodt; results first posted 2022-11-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin. Trials, record NCT01143246. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01143246
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin
- NCT number
- NCT01143246
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 196 participants, actual
- Lead sponsor
- Mallinckrodt
- Conditions
- Hepatorenal Syndrome
- Interventions
- Terlipressin, Placebo
- First posted
- 2010-06-14
- Last updated
- 2022-11-29
- Results first posted
- 2022-11-29
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Confirmed Hepatorenal Syndrome (HRS) Reversal | within 14 days | Confirmed HRS Reversal: The percentage of participants with two serum creatinine (SCr) values of ≤ 1.5 mg/dL at least 48 hours apart, on treatment, and without intervening renal replacement therapy or liver transplant. |
| Secondary | Percentage of Participants With HRS Reversal | within 14 days | HRS reversal is defined as at least one SCr value of ≤ 1.5 mg/dL on treatment (up to 24 hours after the last dose of study medication). |
| Secondary | Percentage of Participants With Transplant-free Survival | Up to 90 days | Transplant-Free Survival up to 90 days, defined as the time (in days) that each participant survives without liver transplantation from the day of randomization. |
| Secondary | Percentage of Participants With Overall Survival | Up to 90 days | Overall Survival up to 90 days, defined as the time (in days) that each participant survives from the day of randomization. |
| Secondary | Percentage of Participants With Serious Adverse Events | Up to 30 days post treatment (within 44 days) | Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessments which qualified for the definition of serious adverse event are reported. |
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 of Participants With Confirmed Hepatorenal Syndrome (HRS) Reversal | within 14 days | ITT population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HRS Reversal | within 14 days | ITT population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Transplant-free Survival | Up to 90 days | ITT population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Overall Survival | Up to 90 days | ITT population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Serious Adverse Events | Up to 30 days post treatment (within 44 days) | Safety population. | percentage of participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Percentage of Participants With Confirmed Hepatorenal Syndrome (HRS) Reversal | Terlipressin | 19.6 | percentage of participants | ||
| Percentage of Participants With Confirmed Hepatorenal Syndrome (HRS) Reversal | Placebo | 13.1 | percentage of participants | ||
| Percentage of Participants With HRS Reversal | Terlipressin | 23.7 | percentage of participants | ||
| Percentage of Participants With HRS Reversal | Placebo | 15.2 | percentage of participants | ||
| Percentage of Participants With Transplant-free Survival | Terlipressin | 30.9 | percentage of participants | ||
| Percentage of Participants With Transplant-free Survival | Placebo | 26.3 | percentage of participants | ||
| Percentage of Participants With Overall Survival | Terlipressin | 57.7 | percentage of participants | ||
| Percentage of Participants With Overall Survival | Placebo | 54.5 | percentage of participants | ||
| Percentage of Participants With Serious Adverse Events | Terlipressin | 66.7 | percentage of participants | ||
| Percentage of Participants With Serious Adverse Events | Placebo | 62.1 | percentage of participants |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Terlipressin | 97 | |
| Overall Study | STARTED | Placebo | 99 | |
| Overall Study | Intent to Treat (ITT) | Terlipressin | 97 | |
| Overall Study | Intent to Treat (ITT) | Placebo | 99 | |
| Overall Study | Safety Population (Treated Participants) | Terlipressin | 93 | |
| Overall Study | Safety Population (Treated Participants) | Placebo | 95 | |
| Overall Study | COMPLETED | Terlipressin | 52 | |
| Overall Study | COMPLETED | Placebo | 48 | |
| Overall Study | NOT COMPLETED | Terlipressin | 45 | |
| Overall Study | NOT COMPLETED | Placebo | 51 |
Source ClinicalTrials.gov
Adverse events276
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 | 10 | 93 | 10 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 9 | 95 | 10 |
| other | Coagulopathy | Blood and lymphatic system disorders | Terlipressin | 5 | 93 | 5 |
| other | Coagulopathy | Blood and lymphatic system disorders | Placebo | 4 | 95 | 4 |
| other | Bradycardia | Cardiac disorders | Terlipressin | 9 | 93 | 10 |
| other | Bradycardia | Cardiac disorders | Placebo | 2 | 95 | 2 |
| other | Abdominal distension | Gastrointestinal disorders | Terlipressin | 6 | 93 | 6 |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 4 | 95 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Terlipressin | 26 | 93 | 27 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 21 | 95 | 22 |
1 to 10 of 276Source ClinicalTrials.gov
See all 276 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Terlipressin | 41 | 97 |
| Total, all-cause mortality | Placebo | 45 | 99 |
| Total, other adverse events | Terlipressin | 87 | 93 |
| Total, other adverse events | Placebo | 82 | 95 |
| Total, serious adverse events | Terlipressin | 62 | 93 |
| Total, serious adverse events | Placebo | 59 | 95 |
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/NCT01143246
GET https://conductscience.org/api/trials/v1/NCT01143246/events?page=2