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Comparison of Endoscopic Band Ligation Plus 24-hour Versus 72-hour Terlipressin Therapy
Plain-language guide to NCT05331768: not phased randomized trial of Terlipressin, 109 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05331768
- Phase
- not phased
- Status
- completed
- Start
- 2021-01-01
- Completion (planned or actual)
- 2021-09-30
- Participants
- 109 (actual)
- Design
- randomized, single-blind, treatment
- Conditions studied
- Esophageal and Gastric Varices
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Terlipressin.
It had two arms (groups): 24-h group (experimental) and 72-h group (active comparator).
The registry classes the interventions as combination product.
More on the Plan
Objective: To compare endoscopic band ligation plus terlipressin for 24 vs 72 hours during acute variceal bleeding in liver cirrhosis.
Who Took Part
The registry lists 109 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Patients of 18 years and older. Diagnosis of liver cirrhosis with a Child-Pugh score ≤ 11 (class B or C). Acute variceal bleeding were included.
The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: patients with contraindications to terlipressin (pregnancy, breastfeeding, or severe cardiopulmonary diseases),; presence of sepsis,; multi-organ failure,.
How the Study Was Run
Design: randomized, parallel-group and single-blind.
Random assignment meant chance, not the researchers, decided who got Terlipressin and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Only one side, usually the participants, was kept unaware of whether Terlipressin was given.
Those kept unaware of assignments: participant.
It started in 2021-01-01 with completion listed for 2021-09-30.
It ran at 1 site in Mexico.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Compare the 24-h group vs 72-h group (time frame: The total study time ranges from the first day of telmipressin infusion to 6 weeks after the event).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Terlipressin in 109 people.
The trial is marked completed; 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.