Trial · NCT03107091
Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites
NCT03107091, Phase 2, Completed, BioVie Inc.; results first posted 2021-07-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites. Trials, record NCT03107091. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03107091
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites
- NCT number
- NCT03107091
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- BioVie Inc.
- Conditions
- Cirrhosis, Ascites Hepatic
- Interventions
- Terlipressin acetate continuous infusion
- First posted
- 2017-04-11
- Last updated
- 2021-07-13
- Results first posted
- 2021-07-13
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites | 28 day treatment period and 28 day post-treatment | Rate of treatment emergent adverse events assessed by physical examination and laboratory safety |
| Primary | Steady State Plasma Levels of Terlipressin and 8-lysine Vasopressin During Terlipressin Continuous Infusion at 2 mg/Day in Cirrhotic Patients With Refractory Ascites | 7 day treatment | Serial sampling for determination of Terlipressin concentration and metabolite 8-lysine vasopressin in plasma at steady state (Css) |
| Secondary | Change in Requirement of Large Volume Paracentesis With Continuous Infusion of Terlipressin | 28 day post-treatment | Comparison of pre-treatment and post-treatment incidence of therapeutic paracentesis and change in volume of ascites removed |
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 | Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites | 28 day treatment period and 28 day post-treatment | Enrolled | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Steady State Plasma Levels of Terlipressin and 8-lysine Vasopressin During Terlipressin Continuous Infusion at 2 mg/Day in Cirrhotic Patients With Refractory Ascites | 7 day treatment | ng/mL | MEAN | |
| SECONDARY | Change in Requirement of Large Volume Paracentesis With Continuous Infusion of Terlipressin | 28 day post-treatment | percent change | MEAN |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites | Terlipressin Acetate Continuous Infusion | TEAE | 6 | Participants | |
| Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites | Terlipressin Acetate Continuous Infusion | Serious AE | 4 | Participants | |
| Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites | Terlipressin Acetate Continuous Infusion | Related TEAE | 3 | Participants | |
| Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites | Terlipressin Acetate Continuous Infusion | Serious related TEAE | 0 | Participants | |
| Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites | Terlipressin Acetate Continuous Infusion | TEAE leading to drug withdrawal | 3 | Participants | |
| Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites | Terlipressin Acetate Continuous Infusion | Grade 3 TEAE | 4 | Participants | |
| Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites | Terlipressin Acetate Continuous Infusion | Fatal TEAE | 0 | Participants | |
| Steady State Plasma Levels of Terlipressin and 8-lysine Vasopressin During Terlipressin Continuous Infusion at 2 mg/Day in Cirrhotic Patients With Refractory Ascites | Terlipressin Acetate Continuous Infusion | Terlipressin | 2.48 | Full Range 1.67 to 3.23 | ng/mL |
| Steady State Plasma Levels of Terlipressin and 8-lysine Vasopressin During Terlipressin Continuous Infusion at 2 mg/Day in Cirrhotic Patients With Refractory Ascites | Terlipressin Acetate Continuous Infusion | 8-lysine vasopressin | 0.089 | Full Range 0.07 to 0.138 | ng/mL |
| Change in Requirement of Large Volume Paracentesis With Continuous Infusion of Terlipressin | Terlipressin Acetate Continuous Infusion | Percent change in volume ascites removed during 28d treatment period versus 28d pre-treatment period | -66.5 | Full Range -100.0 to -35.0 | percent change |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Terlipressin Acetate Continuous Infusion | 6 | |
| Overall Study | COMPLETED | Terlipressin Acetate Continuous Infusion | 5 | |
| Overall Study | NOT COMPLETED | Terlipressin Acetate Continuous Infusion | 1 |
Source ClinicalTrials.gov
Adverse events9
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 | tachycardia | Cardiac disorders | Terlipressin Acetate Continuous Infusion | 1 | 6 | 1 |
| other | diarrhea | Gastrointestinal disorders | Terlipressin Acetate Continuous Infusion | 1 | 6 | 1 |
| other | Energy increased | General disorders | Terlipressin Acetate Continuous Infusion | 1 | 6 | 1 |
| other | decreased appetitie | Metabolism and nutrition disorders | Terlipressin Acetate Continuous Infusion | 1 | 6 | 1 |
| other | Hyponatremia | Metabolism and nutrition disorders | Terlipressin Acetate Continuous Infusion | 1 | 6 | 1 |
| serious | Hepatic encephalopathy | Hepatobiliary disorders | Terlipressin Acetate Continuous Infusion | 2 | 6 | 2 |
| serious | Bacteremia | Infections and infestations | Terlipressin Acetate Continuous Infusion | 1 | 6 | 1 |
| serious | Ruptured umbilical hernia | Gastrointestinal disorders | Terlipressin Acetate Continuous Infusion | 1 | 6 | 1 |
| serious | Partial bowel obstruction | Gastrointestinal disorders | Terlipressin Acetate Continuous Infusion | 1 | 6 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Terlipressin Acetate Continuous Infusion | 0 | 6 |
| Total, other adverse events | Terlipressin Acetate Continuous Infusion | 3 | 6 |
| Total, serious adverse events | Terlipressin Acetate Continuous Infusion | 4 | 6 |
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 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.
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/NCT03107091
GET https://conductscience.org/api/trials/v1/NCT03107091/registered