Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis
This study is currently recruiting participants.
(see Contacts and Locations)
Verified September 2016 by Institute of Liver and Biliary Sciences, India
Sponsor:
Institute of Liver and Biliary Sciences, India
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT01212250
First received: September 7, 2010
Last updated: September 2, 2016
Last verified: September 2016
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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:
Genetics Home Reference related topics:
North American Indian childhood cirrhosis
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 ] [ 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
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: | September 2, 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 September 23, 2016