NCT01196507

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 8, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

June 15, 2016

Status Verified

December 1, 2013

Enrollment Period

3.4 years

First QC Date

September 4, 2010

Last Update Submit

June 14, 2016

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 Years

Secondary Outcomes (3)

  • Survival

    2 Years

  • adverse effects of drugs

    2 Years

  • reduction in HVPG

    1 Year

Study Arms (2)

Carvedilol

EXPERIMENTAL

Tablet Carvedilol 12.5 mg BD or maximum tolerated dose

Drug: Carvedilol

Placebo

PLACEBO COMPARATOR

Placebo tablets 2 to 4 BD

Drug: Placebo

Interventions

CarvedilolDRUG

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.

Carvedilol
PlaceboDRUG

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.

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110 070, India

Location

Related Publications (1)

  • 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. 2017 Oct;66(10):1838-1843. doi: 10.1136/gutjnl-2016-311735. Epub 2016 Jun 13.

    PMID: 27298379DERIVED

MeSH Terms

Conditions

Fibrosis

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-Ring

Study Officials

  • Shiv Kumar Sarin, MBBS, MD, DM

    Institute of Liver & Biliary Sciences (ILBS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2010

First Posted

September 8, 2010

Study Start

November 1, 2010

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

June 15, 2016

Record last verified: 2013-12

Locations

IN(1)