Portal HypertensionPhase 4NCT01070641
RCT of Carvedilol Versus Variceal Band Ligation in the Primary Prophylaxis of Oesophageal Variceal Haemorrhage
A Phase 4 study testing Carvedilol and Esophageal variceal band ligation in people with Portal Hypertension, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Aim To compare Carvedilol with variceal band ligation in the prevention of first variceal bleed. End points of trial Primary: Variceal hemorrhage Secondary: Death Study design Randomised controlled clinical trial. Results analysed for the above end points on an intention-to-treat basis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Portal Hypertension
- What is being tested?
- Carvedilol and Esophageal variceal band ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 sitePakistan
- Study dates
- Jun 2002to Jul 2011
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with liver cirrhosis and on endoscopy having grade II, or larger oesophageal varices and who have not bled previously from varices.
Who cannot join
- Age <18 or > 75 years.
- Pregnant or lactating patients: patients of childbearing age who are not on contraception.
- Allergy to Carvedilol.
- Already on beta blockers or nitrates.
- Presence of malignancy that will significantly affect survival.
- Presence of severe systemic illness e.g. cardiorespiratory, active sepsis.
- Psychiatric disease or learning difficulty that will prevent the granting of informed consent.
- Presence of obstructive airways disease.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University Hospital
Karachi, Sindh, 74800
Syed Hasnain A Shah, MBBS, FRCP, 00922134930051 ext. 4676, hasnail.alishah@aku.edu
Syed Hasnain A Shah, FRCP
About this study
Official title: RCT of Carvedilol vs Variceal Band Ligation in the Primary Prophylaxis of Oesophageal Variceal Haemorrhage
Aim To compare Carvedilol with variceal band ligation in the prevention of first variceal bleed.
End points of trial Primary: Variceal hemorrhage Secondary: Death
Study design
Randomised controlled clinical trial. Results analysed for the above end points on an intention-to-treat basis.
Read the detailed description
Patients from the Gastroenterology section of the Aga Khan University, Karachi, with liver cirrhosis and on endoscopy having grade II, or larger oesophageal varices and who have not bled previously from varices.
Method All suitable patients will be recruited after informed consent is given. Randomisation of treatment is by sealed envelopes prepared in batches of 20.
Carvedilol This will be administered as a once daily dose of 12.5mg.
Variceal band ligation Endoscopy will be performed ever two weeks until eradication of oesophageal varices. Eradication is achieved when no varices or only grade I varices (varices which are small and flatten on air insufflations in the oesophagus) are present. Subsequent endoscopy sessions will be progressively less frequent, at intervals of 3 months, 6 months and 12 months thereafter. Should varices recur, the protocol for eradication as described above will be re-instituted.
Follow-up This will take place in a dedicated clinic. First visit is six weeks after initiation of treatment and three monthly thereafter. Clinical and laboratory parameters will be obtained at each visit. All patients with alcoholic liver disease will be asked to provide an up-to-date status on drinking. Treatment will cease upon reaching any of these end-points: variceal haemorrhage, death or liver transplantation. Duration of follow-up is defined as time from randomisation to the above end points or to the last follow-up date available.
- Conditions
- Portal Hypertension
- Being tested
- Carvedilol, Esophageal variceal band ligation
- Keywords
- CARVEDILOL, VARICEAL BAND LIGATION, PRIMARY PROPHYLAXIS
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarvedilolDrug
Also called carvida
Carvedilol 12.5mg QD
Esophageal variceal band ligationProcedure or surgery
Also called EVBL
Each patient will undergo for variceal band ligation after 3 weeks till the eradication of varices
| Study group | Role | What they receive |
|---|---|---|
| Carvedilol | Active comparator | Each patient will receive Carvedilol 12.5mg QD Receives: Drug: Carvedilol |
| Esophageal Variceal Band Ligation | Active comparator | Each patient will undergo for serial esophageal variceal band ligations after 3 weeks of last session till the eradication of varices Receives: Procedure: Esophageal variceal band ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variceal hemorrhage
Measured: one year
Secondary outcomes (1)
death
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2010 (estimated)
- Study startJun 2002
- Primary completionFeb 2011 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Investigators
- Syed hasnain A Shah, MBBS, FRCP, Principal investigator, Aga Khan University Hospital, Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070641
- Sponsor's protocol ID
- RCT carvidalol vs EVBL
- Status last verified
- Feb 2010
- First submitted
- 17 Feb 2010
- Last updated
- 18 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of Carvedilol vs Variceal Band Ligation in the Primary Prophylaxis of Oesophageal Variceal Haemorrhage
- ClinicalTrials.gov ID
- NCT01070641
- Acronym / sponsor ID
- RCT carvidalol vs EVBL
- Conditions
- Portal Hypertension
- Keywords
- CARVEDILOL, VARICEAL BAND LIGATION, PRIMARY PROPHYLAXIS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Jun 2002
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 18 Feb 2010 (estimated)
- 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.
Aim To compare Carvedilol with variceal band ligation in the prevention of first variceal bleed.
End points of trial Primary: Variceal hemorrhage Secondary: Death
Study design
Randomised controlled clinical trial. Results analysed for the above end points on an intention-to-treat basis.
Detailed description
Patients from the Gastroenterology section of the Aga Khan University, Karachi, with liver cirrhosis and on endoscopy having grade II, or larger oesophageal varices and who have not bled previously from varices.
Method All suitable patients will be recruited after informed consent is given. Randomisation of treatment is by sealed envelopes prepared in batches of 20.
Carvedilol This will be administered as a once daily dose of 12.5mg.
Variceal band ligation Endoscopy will be performed ever two weeks until eradication of oesophageal varices. Eradication is achieved when no varices or only grade I varices (varices which are small and flatten on air insufflations in the oesophagus) are present. Subsequent endoscopy sessions will be progressively less frequent, at intervals of 3 months, 6 months and 12 months thereafter. Should varices recur, the protocol for eradication as described above will be re-instituted.
Follow-up This will take place in a dedicated clinic. First visit is six weeks after initiation of treatment and three monthly thereafter. Clinical and laboratory parameters will be obtained at each visit. All patients with alcoholic liver disease will be asked to provide an up-to-date status on drinking. Treatment will cease upon reaching any of these end-points: variceal haemorrhage, death or liver transplantation. Duration of follow-up is defined as time from randomisation to the above end points or to the last follow-up date available.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carvedilol | Active comparator | Drug: CarvedilolEach patient will receive Carvedilol 12.5mg QD |
| Esophageal Variceal Band Ligation | Active comparator | Procedure: Esophageal variceal band ligationEach patient will undergo for serial esophageal variceal band ligations after 3 weeks of last session till the eradication of varices |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with liver cirrhosis and on endoscopy having grade II, or larger oesophageal varices and who have not bled previously from varices.
Key exclusion criteria (8 listed)
- Age <18 or > 75 years.
- Pregnant or lactating patients: patients of childbearing age who are not on contraception.
- Allergy to Carvedilol.
- Already on beta blockers or nitrates.
- Presence of malignancy that will significantly affect survival.
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 |
|---|---|---|
| CarvedilolAlso: carvidaCarvedilol 12.5mg QD | Drug | Carvedilol |
| Esophageal variceal band ligationAlso: EVBLEach patient will undergo for variceal band ligation after 3 weeks till the eradication of varices | Procedure or surgery | Esophageal Variceal Band Ligation |
Primary outcome
Variceal hemorrhage
Time frame: one year
1 secondary outcome
death
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2010.
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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.
Syed hasnain A Shah, MBBS, FRCP principal investigator
Aga Khan University Hospital, Karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carvedilol and Esophageal variceal band ligation in people with Portal Hypertension, run by Aga Khan University at 1 site in Pakistan.
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 1 inclusion and 8 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 18 Feb 2010. 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 Pakistan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Syed Hasnain A Shah, MBBS, FRCP (00922134930051 ext. 4676, hasnain.alishah@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variceal hemorrhage (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2010.