ClinicalTrials.gg
RecruitingNCT04499898Updated Aug 5, 2020

Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding

A Phase 2/3 interventional study of Carvedilol and Endoscopic band ligation in Esophageal Varices, sponsored by Sherief Abd-Elsalam. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-05.

Sponsored by Sherief Abd-Elsalam · Phase 2/3, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Oct 2018, registered Aug 2020).
  • Started Oct 2018; still recruiting 8 years 1 month later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
306
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies testing carvedilol in Esophageal and Gastric Varices — 1 open to participants now, 2 under way, 1 of them phase 3. Carvedilol · Esophageal and Gastric Varices.

Planned enrollment
5th of 11
306 · median 240
Started
2018
with 1 other
Phase 2/3
Only one
of the 11
Registered
9th of 11
by date
Lead sponsor
1 of 11
Sherief Abd-Elsalam

Among the 11 studies testing carvedilol in Esophageal and Gastric Varices, this one is the 5th largest by planned enrollment, is one of 2 that started in 2018, is the only one in phase 2/3, and was the 9th registered.

By phase

11 studies; the count open now beside each. This study's row is marked.

Phase 46 · 0 open
No phase3 · 0 open
Phase 2/3this study1 · 1 open
Phase 31 · 0 open

By the year they started

First in 2010; this study’s year is marked. 2 started in 2018.

Tested beside carvedilol

Size and results

Median enrollment 240 across the 11 interventional studies. Of the 3 that completed or were terminated, 1 (33%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 11 studies testing carvedilol in Esophageal and Gastric Varices, or all of them as a file.
02

Study summary

Carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal bleeding in cirrhotic patients with arterial hypertension

Read the detailed description

A Randomized controlled trial of carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal bleeding in cirrhotic patients with arterial hypertension

03

Conditions studied

  • Esophageal Varices
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    • Aged >18 years

      • Cirrhotic patients with arterial hypertension
      • Endoscopic evidence of medium/large-sized esophageal varices

Exclusion criteria

Exclusion Criteria:

    • History of variceal bleeding or previous primary prevention of varices.

      • Portal vein thrombosis or previous porto-systemic shunts as TIPS.
      • Patients on drugs affecting portal pressure (beta blockers, nitrates).
      • Advanced cardiovascular disease including acute myocardial infarction, atrio-ventricular block, congestive heart failure, chronic peripheral ischemia, severe bradycardia.
      • Patients with severe respiratory diseases (, bronchial asthma).
      • Uncontrolled diabetes mellitus
      • Renal impairment
      • Hepatocellular carcinoma
      • Allergy to carvedilol
      • Pregnancy or lactation
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
306 participants (estimated)

Study arms

  • Experimental
    carvedilol

    Carvedilol

    Drug: Carvedilol

  • Active comparator
    Band Ligation

    Band Ligation

    Procedure: Endoscopic band ligation

Interventions

  • Carvedilol

    Also known as: carvid

  • ProcedureEndoscopic band ligation

    Endoscopic band ligation

    Also known as: band ligation

06

What researchers measure

Primary outcomes

  1. Number of patients with the first variceal bleeding within 1 year

    The number of patients with the first variceal bleeding within 1 year

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2018 (actual). Primary completion is estimated for Dec 2030, 146 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 1, 2020
First posted
Aug 5, 2020
StartActual
Oct 1, 2018
Primary completionEst.
Dec 1, 2030
CompletionEst.
Dec 10, 2030
Last update
Aug 5, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04499898
Lead sponsor
Sherief Abd-Elsalam
Responsible party
Sherief Abd-Elsalam (Ass. Prof. Tropical Medicine, Tanta University) — Sponsor-investigator
First posted
Aug 5, 2020
Start date
Oct 1, 2018
Primary completion
Dec 1, 2030 (estimated)
Completion
Dec 10, 2030 (estimated)
Last update
Aug 5, 2020

Study contacts

Sherief Abd-Elsalam, ass. prof.
Contact
sheriefabdelsalam@yahoo.com
00201147773440
Nabila el-gazzar, ass. lect.
Contact
sheriefabdelsalam@yahoo.com
00201147773440
Asem Elfert, Prof
study director · Tanta University - Faculty of Medicine
Nabila Abd El-Nasser Abd El-Wahed El-Gazzar, ass. lect
principal investigator · Tanta University Faculty of medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Carvedilol

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