Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Institute of Liver and Biliary Sciences, India
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT01212250
First received: September 7, 2010
Last updated: March 1, 2016
Last verified: February 2016
  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 6.25 mg BD. After randomization they will be followed up for one year.

The investigators hypothesized that efficacy of carvedilol is equal to the efficacy of placebo in the pre primary prophylaxis of esophageal varices in cirrhosis.


Condition Intervention
Cirrhosis
Drug: carvedilol
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complications of cirrhosis (ascites, hepatic encephalopathy, SBP), [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Number of patient dying in a period of one year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Number of patients needing discontinuation of therapy due to adverse effects. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 132
Study Start Date: September 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212250

Contacts
Contact: Shiv Kumar Sarin, DM 011-46300000 shivsarin@gmail.com

Locations
India
Institute of Liver & Biliary Sciences (ILBS) Recruiting
New Delhi, Delhi, India
Contact: Chitranshu Vashishtha, DM    +91-9540951042    chitranshuv@hotmail.com,   
Principal Investigator: Chitranshu Vashishtha, 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 
Study First Received: September 7, 2010
Last Updated: March 1, 2016
Health Authority: India: Ministry of Health

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

ClinicalTrials.gov processed this record on August 22, 2016