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Early Primary Prophylaxis of Esophageal Varices

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT01196507
First received: September 4, 2010
Last updated: June 14, 2016
Last verified: December 2013
September 4, 2010
June 14, 2016
November 2010
April 2014   (Final data collection date for primary outcome measure)
The primary endpoint of the study is the the proportions of patients who develop large varices (Gd 3 or Gd 4) during the period of 2 year in each group. [ Time Frame: 2 Years ]
The primary endpoint of the study is the the proportions of patients who develop large varices (Gd 3 or Gd 4) at 1 year in each group. [ Time Frame: 1 year ]
Complete list of historical versions of study NCT01196507 on ClinicalTrials.gov Archive Site
  • Survival [ Time Frame: 2 Years ]
  • adverse effects of drugs [ Time Frame: 2 Years ]
  • reduction in HVPG [ Time Frame: 1 Year ]
  • development of complications of cirrhosis (ascites, hepatic encephalopathy, SBP), [ Time Frame: 1 year ]
  • adverse effects of drugs [ Time Frame: 1 year ]
  • Mortality [ Time Frame: 1 year ]
Not Provided
Not Provided
 
Early Primary Prophylaxis of Esophageal Varices
A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Early Primary Prophylaxis of Esophageal Varices in Cirrhosis.
Patients of cirrhosis with portal hypertension aged 18 to 75 years who have small esophageal varices with or without red color signs and have not bled previously 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. The primary endpoint of the study is the the proportions of patients who develop large varices (Gd 3 or Gd 4) at 1 year in each group. The secondary endpoint are survival,reduction in HVPG,change in CTP and MELD score& adverse events.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Cirrhosis
  • 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 or with a maximum of 12.5 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 4 BD.
  • Experimental: Carvedilol
    Tablet Carvedilol 12.5 mg BD or maximum tolerated dose
    Intervention: Drug: Carvedilol
  • Placebo Comparator: Placebo
    Placebo tablets 2 to 4 BD
    Intervention: Drug: Placebo
Bhardwaj A, Kedarisetty CK, Vashishtha C, Bhadoria AS, Jindal A, Kumar G, Choudhary A, Shasthry SM, Maiwall R, Kumar M, Bhatia V, Sarin SK. Carvedilol delays the progression of small oesophageal varices in patients with cirrhosis: a randomised placebo-controlled trial. Gut. 2016 Jun 13. pii: gutjnl-2016-311735. doi: 10.1136/gutjnl-2016-311735. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
April 2014
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

- Patients of cirrhosis with portal hypertension aged 18 to 75 years who have small esophageal varices with or without red color signs and have not bled previously.

Exclusion Criteria:

  • Any contra-indication to beta-blockers
  • Any EVL or sclerotherapy within last 3 months
  • Child Turcotte Pugh (CTP) score > 12, refractory ascites, hepatorenal syndrome
  • Any past history of surgery for portal hypertension
  • Significant cardio or pulmonary co-morbidity
  • Any malignancy that affects survival.
  • Active alcohol abuse or last intake ≤ 4 weeks to avoid possibility of ongoing alcohol hepatitis.
  • Past history of surgery for portal hypertension
  • Uncontrolled diabetes
  • Peripheral vascular disease
  • Refusal to participate in the study
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT01196507
ILBS PHT-02
No
Not Provided
Not Provided
Institute of Liver and Biliary Sciences, India
Institute of Liver and Biliary Sciences, India
Not Provided
Principal Investigator: Shiv Kumar Sarin, MBBS, MD, DM Institute of Liver & Biliary Sciences (ILBS)
Institute of Liver and Biliary Sciences, India
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP