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Carvedilol, Endoscopic Variceal Ligation or Combination of Both for Prevention of First Variceal Bleed in Child's B & C Cirrhosis

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ClinicalTrials.gov Identifier: NCT03069339
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Brief Summary:
Study Design: Open labeled randomized controlled trial. The study will be conducted on patients attending outpatient or admitted to admitted to Department of Hepatology from January 2017 to December 2018 at ILBS, New Delhi

Condition or disease Intervention/treatment Phase
Cirrhosis Drug: Carvedilol Procedure: Endoscopic Variceal Ligation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Carvedilol, Endoscopic Variceal Ligation or Combination of Both for Prevention of First Variceal Bleed in Child's B & C Cirrhosis: A Randomized Controlled Trial
Actual Study Start Date : March 15, 2017
Estimated Primary Completion Date : March 15, 2019
Estimated Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Carvedilol+EVL Drug: Carvedilol
Carvedilol will start at starting dose of 3.125 mg BD followed by 6.25 mg BD followed by 12.5 mg BD if BP 90/60 mmHg and HR 55/min

Procedure: Endoscopic Variceal Ligation
EVL will be done every 3 weeks till eradication

Experimental: Carvedilol Drug: Carvedilol
Carvedilol will start at starting dose of 3.125 mg BD followed by 6.25 mg BD followed by 12.5 mg BD if BP 90/60 mmHg and HR 55/min

Active Comparator: EVL Procedure: Endoscopic Variceal Ligation
EVL will be done every 3 weeks till eradication




Primary Outcome Measures :
  1. Reduction in the incidence of first variceal bleed at 1 year. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Overall and bleed related Survival in all the 3 groups [ Time Frame: 1 year ]
  2. Bleed related Survival in all the 3 groups [ Time Frame: 1 year ]
  3. Improvement in Child-Turcotte-Pugh (CTP) score in all the 3 groups [ Time Frame: 1 year ]
  4. Improvement in Model for End Stage Liver Disease (MELD) score in all the 3 groups [ Time Frame: 1 year ]
  5. Incidence of Spontaneous Bacterial Peritonitis (SBP) in all the 3 groups [ Time Frame: 1 year ]
  6. Incidence of Acute Kidney Injury (AKI) in all the 3 groups [ Time Frame: 1 year ]
  7. Incidence of Shock in all the 3 groups [ Time Frame: 1 year ]
  8. Incidence of new ascites in all the 3 groups [ Time Frame: 1 year ]
  9. HVPG response at 1year in all the 3 groups [ Time Frame: 1 year ]
  10. HVPG response at 2 year in all the 3 groups [ Time Frame: 2 year ]
  11. HVPG response in all the 3 groups [ Time Frame: 3 months ]
  12. Treatment related side effects in all the 3 groups [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Liver Cirrhotics between 18-70 yrs of age (cirrhosis diagnosed on the basis of clinical, biochemical, fibroscan & imaging.)
  • CTP ≥ 7-15 (Child's B/C)
  • Small esophageal varices with RCS and large esophageal varices (>5 mm)
  • No history of previous bleed

Exclusion Criteria:

  • Malignancy-HCC, PVT
  • Child A
  • MELD >35
  • Contraindications to β blockers.
  • Platelet count < 30,000/mm3
  • Previous endoscopic variceal treatment. (Beyond 21 days)
  • Patients having an indication for TIPS or requiring more than 1 therapeutic ascitic tapping/month
  • Post TIPS, Shunt surgery
  • Acute kidney injury (Sr.Cr>1.5mg/dl)
  • Non cirrhotic portal hypertension
  • Acute on chronic liver failure

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): NCT03069339


Contacts
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Contact: Dr Apurva Pandey, MD 01146300000 pandeap@gmail.com

Locations
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India
Institute of liver and Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Contact: Dr Apurva Pandey, MD    +91-11-01146300000    pandeap@gmail.com   
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India

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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT03069339     History of Changes
Other Study ID Numbers: ILBS-Cirrhosis-07
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists