CirrhosisNCT03069339
Carvedilol, Endoscopic Variceal Ligation or Combination of Both for Prevention of First Variceal Bleed in Child's B & C Cirrhosis
A study testing Carvedilol and Endoscopic Variceal Ligation in people with Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Carvedilol and Endoscopic Variceal Ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteIndia
- Study dates
- 15 Mar 2017to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Malignancy-HCC, PVT
- Child A
- MELD >35
- Contraindications to β blockers.
- Platelet count < 30,000/mm3
- Previous endoscopic variceal treatment. (Beyond 21 days)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
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
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
- Conditions
- Cirrhosis
- Being tested
- Carvedilol, Endoscopic Variceal Ligation
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarvedilolDrug
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
Endoscopic Variceal LigationProcedure or surgery
EVL will be done every 3 weeks till eradication
| Study group | Role | What they receive |
|---|---|---|
| Carvedilol+EVL | Experimental | Not described Receives: Drug: Carvedilol; Procedure: Endoscopic Variceal Ligation |
| Carvedilol | Experimental | Not described Receives: Drug: Carvedilol |
| EVL | Active comparator | Not described Receives: Procedure: Endoscopic Variceal Ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the incidence of first variceal bleed at 1 year.
Measured: 1 year
Secondary outcomes (10)
Overall and bleed related Survival in all the 3 groups
Measured: 1 year
Bleed related Survival in all the 3 groups
Measured: 1 year
Improvement in Child-Turcotte-Pugh (CTP) score in all the 3 groups
Measured: 1 year
Improvement in Model for End Stage Liver Disease (MELD) score in all the 3 groups
Measured: 1 year
Incidence of Spontaneous Bacterial Peritonitis (SBP) in all the 3 groups
Measured: 1 year
Incidence of Acute Kidney Injury (AKI) in all the 3 groups
Measured: 1 year
Incidence of Shock in all the 3 groups
Measured: 1 year
Incidence of new ascites in all the 3 groups
Measured: 1 year
HVPG response at 1year in all the 3 groups
Measured: 1 year
Treatment related side effects in all the 3 groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start15 Mar 2017
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069339
- Sponsor's protocol ID
- ILBS-Cirrhosis-07
- Status last verified
- Oct 2019
- First submitted
- 28 Feb 2017
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tevethia HV, Pande A, Vijayaraghavan R, Kumar G, Sarin SK. Combination of carvedilol with variceal band ligation in prevention of first variceal bleed in Child-Turcotte-Pugh B and C cirrhosis with high-risk oesophageal varices: the 'CAVARLY TRIAL'. Gut. 2024 Oct 7;73(11):1844-1853. doi: 10.1136/gutjnl-2023-331181.
PubMed 39067870
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03069339
- Acronym / sponsor ID
- ILBS-Cirrhosis-07
- Conditions
- Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carvedilol+EVL | Experimental | Drug: Carvedilol, Procedure: Endoscopic Variceal Ligation |
| Carvedilol | Experimental | Drug: Carvedilol |
| EVL | Active comparator | Procedure: Endoscopic Variceal Ligation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- Malignancy-HCC, PVT
- Child A
- MELD >35
- Contraindications to β blockers.
- Platelet count < 30,000/mm3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarvedilolCarvedilol 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 | Drug | Carvedilol, Carvedilol+EVL |
| Endoscopic Variceal LigationEVL will be done every 3 weeks till eradication | Procedure or surgery | Carvedilol+EVL, EVL |
Primary outcome
Reduction in the incidence of first variceal bleed at 1 year.
Time frame: 1 year
10 secondary outcomes
Overall and bleed related Survival in all the 3 groups
Time frame: 1 year
Bleed related Survival in all the 3 groups
Time frame: 1 year
Improvement in Child-Turcotte-Pugh (CTP) score in all the 3 groups
Time frame: 1 year
Improvement in Model for End Stage Liver Disease (MELD) score in all the 3 groups
Time frame: 1 year
Incidence of Spontaneous Bacterial Peritonitis (SBP) in all the 3 groups
Time frame: 1 year
Incidence of Acute Kidney Injury (AKI) in all the 3 groups
Time frame: 1 year
Incidence of Shock in all the 3 groups
Time frame: 1 year
Incidence of new ascites in all the 3 groups
Time frame: 1 year
HVPG response at 1year in all the 3 groups
Time frame: 1 year
Treatment related side effects in all the 3 groups
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Derived from this study: PubMed 39067870Tevethia HV, Pande A, Vijayaraghavan R, Kumar G, Sarin SK. Combination of carvedilol with variceal band ligation in prevention of first variceal bleed in Child-Turcotte-Pugh B and C cirrhosis with high-risk oesophageal varices: the 'CAVARLY TRIAL'. Gut. 2024 Oct 7;73(11):1844-1853. doi: 10.1136/gutjnl-2023-331181.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carvedilol and Endoscopic Variceal Ligation in people with Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the incidence of first variceal bleed at 1 year. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03069339, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.