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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03776955
Other study ID # 125861
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date June 17, 2019
Est. completion date December 2024

Study information

Verified date October 2019
Source King's College Hospital NHS Trust
Contact Vishal Patel, BSc, MBBS, MRCP, MPhil
Phone +44 (0)20 3299 3654
Email vishal.patel@nhs.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine if carvedilol reduces the rate of variceal haemorrhage in patients with cirrhosis and small oesophageal varices


Description:

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Study Design


Intervention

Drug:
Carvedilol
Oral tablet

Locations

Country Name City State
United Kingdom Royal Victoria Hospital Belfast Northern Ireland
United Kingdom Queen Elizabeth Hospital Birmingham
United Kingdom King's College Hosptial NHS Foundation Trust (Denmark Hill) London
United Kingdom Royal London Hospital (Barts) London

Sponsors (6)

Lead Sponsor Collaborator
King's College Hospital NHS Trust Brighton and Sussex University Hospitals NHS Trust, Cardiff University, Guy's and St Thomas' NHS Foundation Trust, King's College London, St George's University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Variceal bleeding Time to first variceal haemorrhage 3 years
Primary Health Economic assessment Assess the cost effectiveness of early intervention with non specific beta blockers in this patient population. 3 years
Secondary Variceal bleed rate Number of variceal bleeds by allocation 1 and 3 years
Secondary Variceal bleeding needing intervention Number of patients that progress to medium/large varices requiring clinical intervention 3 years
Secondary Composite of variceal bleed rate and bleeding needing intervention Composite of variceal bleed rate and bleeding needing intervention. i.e. Unit less measure of rate of ((Number of patients who bled) PLUS (Number of patients who progressed without bleeding)) / (Number of patients in that arm at randomisation) at 3 years ranging from 0 to 1 3 years
Secondary Clinical decompensation Number of patients with clinical decompensation (spontaneous bacterial peritonitis, new ascites, new hepatic encephalopathy) in the active and inactive IMP groups 3 years
Secondary Child Pugh Score for Cirrhosis mortality Child Pugh Score for Cirrhosis mortalityin the active and inactive IMP groups. Range 5-15. Higher scores represent worse outcomes. 3 years
Secondary Model for end-stage liver disease (MELD) score MELD score in the active and inactive IMP groups.Range 6-40. Higher scores represent worse outcomes. 3 years
Secondary Survival (Overall, liver related, cardio-vascular related) Survival (Overall, liver related, cardio-vascular related) 3 years
Secondary Quality of life assessment Quality of life score using EQ5D-5L in the active and inactive IMP groups. Range 5-25. Higher scores represent worse outcomes. 3 years
See also
  Status Clinical Trial Phase
Completed NCT01335516 - Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices N/A
Completed NCT02852161 - The Accuracy and Acceptability of Magnet Assisted Capsule Endoscopy in the Diagnosis of Esophageal Pathology: a Pilot Study N/A