Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis

This study is currently recruiting participants.

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Contacts and Locations

Verified September 2016 by Institute of Liver and Biliary Sciences, India

Sponsor:

ClinicalTrials.gov Identifier:

NCT01212250

First Posted: September 30, 2010

Last Update Posted: March 1, 2017

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Information provided by (Responsible Party):

Institute of Liver and Biliary Sciences, India

Purpose

Patients of cirrhosis aged 18 to 75 years who have no esophageal varices will be enrolled. After baseline evaluation, the participants will be randomized to receive either Placebo or Carvedilol 12.5 mg BD. After randomization they will be followed up for one year.

Condition	Intervention
Cirrhosis	Drug: carvedilol Drug: Placebo


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention
Official Title:	A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis Varicose Veins

Drug Information available for: Carvedilol Carvedilol hydrochloride

Genetic and Rare Diseases Information Center resources: Esophageal Varices

U.S. FDA Resources

Further study details as provided by Institute of Liver and Biliary Sciences, India:

Primary Outcome Measures:

the proportions of patients who develop esophageal varices at 1 year in each group. [ Time Frame: 1 year ]

Secondary Outcome Measures:

Number of patient dying in a period of one year [ Time Frame: 1 year ]
Number of patients needing discontinuation of therapy due to adverse effects. [ Time Frame: 1 year ]
Reduction in Hepatic Venous Pressure Gradient in both groups [ Time Frame: 1 year ]


Estimated Enrollment:	132
Study Start Date:	September 2010
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Carvedilol Tablet 6.25 mg BD	Drug: carvedilol Carvedilol will be administered orally at a start dose of 3.125 mg twice daily. After 1 week, this will increased if systolic blood pressure does not fall below 90 mm Hg. The patient will receive the maximum tolerated dose of carvedilol with a maximum of 6.25 BD.
Placebo Comparator: placebo Placebo tablets 2 BD	Drug: Placebo The placebo tablets will be identical to the carvedilol tablets. First the patients will receive placebo in the dose of 1 BD. Then depending on his tolerance it will be increased to a maximum of 2 BD.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients of cirrhosis aged 18 to 75 years who have no esophageal or gastric varices.

Exclusion Criteria:

Any contra-indication to beta-blockers
Any past EVL or sclerotherapy
Any past history of surgery for portal hypertension
Significant cardio or pulmonary co-morbidity
Any malignancy
Refusal to participate in the study

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01212250

Contacts


Contact: Ankur Jindal, DM	011-46300000	ankur.jindal3@gmail.com

Locations


India
Institute of Liver & Biliary Sciences (ILBS)	Recruiting
New Delhi, Delhi, India
Contact: Ankur Jindal, DM 9582670984 ankur.jindal3@gmail.com
Principal Investigator: Ankur Jindal, MBBS, MD, DM

Sponsors and Collaborators

Institute of Liver and Biliary Sciences, India

More Information


Responsible Party:	Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:	NCT01212250 History of Changes
Other Study ID Numbers:	ILBS PHT-003
First Submitted:	September 7, 2010
First Posted:	September 30, 2010
Last Update Posted:	March 1, 2017
Last Verified:	September 2016

Additional relevant MeSH terms:


Fibrosis Liver Cirrhosis Esophageal and Gastric Varices Pathologic Processes Liver Diseases Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Hypertension, Portal Carvedilol	Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antihypertensive Agents Vasodilator Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists

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