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Efficacy of Continuous Terlipressin Therapy After Endoscopic Variceal Ligation
Plain-language guide to NCT06027970: phase 3 randomized trial of Terlipressin, 165 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06027970
- Phase
- phase 3
- Status
- status unknown
- Start
- 2023-09
- Completion (planned or actual)
- 2024-08
- Participants
- 165 (estimated)
- Design
- randomized, triple-blind, treatment
- Conditions studied
- Variceal Hemorrhage
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Terlipressin.
Prompt endoscopic variceal ligation (EVL) is therapeutic as well as diagnostic.
It had two arms (groups): Treatment (active comparator) and Control (placebo comparator).
The registry classes the interventions as drug and other.
Who Took Part
Enrollment: 165 planned participants were the target.
It was open to people of any sex aged from 18 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Irrespective of gender. Age ≥ 18 years. All the patients with endoscopy proven acute VH with successful EVL done.
The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: patients not receiving pre-evl terlipressin therapy; not achieving haemostasis during evl; EVL done beyond 48 hours of admission because of hemodynamic instability or encephalopathy.
How the Study Was Run
The set-up was randomized, parallel-group and triple-blind.
The participants were allocated by chance, so the Terlipressin group and the comparison group should start out alike.
The Terlipressin group and the comparison group ran side by side rather than switching.
As a double-blind Terlipressin study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant, care provider and investigator.
It started in 2023-09 with completion listed for 2024-08.
It ran at 1 site in India.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Re-bleed (time frame: 7 days). Mortality (time frame: 7 days).
It also tracked 3 secondary outcomes, for example Duration of hospital stay, need for blood transfusions and Adverse drug reaction (ADR).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Terlipressin in 165 people.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Terlipressin compound page, all human trials.
Our Notes on the Compound
Terlipressin: A synthetic vasopressin analog (Terlivaz) used for kidney failure in advanced liver disease and for variceal bleeding.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.