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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01070641
Other study ID # RCT carvidalol vs EVBL
Secondary ID
Status Recruiting
Phase Phase 4
First received February 17, 2010
Last updated February 17, 2010
Start date June 2002
Est. completion date July 2011

Study information

Verified date February 2010
Source Aga Khan University
Contact Syed Hasnain A Shah, MBBS, FRCP
Phone 00922134930051
Email hasnain.alishah@aku.edu
Is FDA regulated No
Health authority Pakistan: Research Ethics CommitteeUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Aim To compare Carvedilol with variceal band ligation in the prevention of first variceal bleed.

End points of trial Primary: Variceal hemorrhage Secondary: Death

Study design

Randomised controlled clinical trial. Results analysed for the above end points on an intention-to-treat basis.


Description:

Patients from the Gastroenterology section of the Aga Khan University, Karachi, with liver cirrhosis and on endoscopy having grade II, or larger oesophageal varices and who have not bled previously from varices.

Method All suitable patients will be recruited after informed consent is given. Randomisation of treatment is by sealed envelopes prepared in batches of 20.

Carvedilol This will be administered as a once daily dose of 12.5mg.

Variceal band ligation Endoscopy will be performed ever two weeks until eradication of oesophageal varices. Eradication is achieved when no varices or only grade I varices (varices which are small and flatten on air insufflations in the oesophagus) are present. Subsequent endoscopy sessions will be progressively less frequent, at intervals of 3 months, 6 months and 12 months thereafter. Should varices recur, the protocol for eradication as described above will be re-instituted.

Follow-up This will take place in a dedicated clinic. First visit is six weeks after initiation of treatment and three monthly thereafter. Clinical and laboratory parameters will be obtained at each visit. All patients with alcoholic liver disease will be asked to provide an up-to-date status on drinking. Treatment will cease upon reaching any of these end-points: variceal haemorrhage, death or liver transplantation. Duration of follow-up is defined as time from randomisation to the above end points or to the last follow-up date available.


Recruitment information / eligibility

Status Recruiting
Enrollment 148
Est. completion date July 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Patients with liver cirrhosis and on endoscopy having grade II, or larger oesophageal varices and who have not bled previously from varices.

Exclusion Criteria:

- Age <18 or > 75 years.

- Pregnant or lactating patients: patients of childbearing age who are not on contraception.

- Allergy to Carvedilol.

- Already on beta blockers or nitrates.

- Presence of malignancy that will significantly affect survival.

- Presence of severe systemic illness e.g. cardiorespiratory, active sepsis.

- Psychiatric disease or learning difficulty that will prevent the granting of informed consent.

- Presence of obstructive airways disease.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Carvedilol
Carvedilol 12.5mg QD
Procedure:
Esophageal variceal band ligation
Each patient will undergo for variceal band ligation after 3 weeks till the eradication of varices

Locations

Country Name City State
Pakistan Aga Khan University Hospital Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Variceal hemorrhage one year Yes
Secondary death one year Yes
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