Acute on Chronic Liver FailureNCT02583698
Efficacy of Nonselective Beta Blocker vs Placebo in Patients With Acute-on-chronic Liver Failure With Small/ no Esophageal Varices
A study testing Carvedilol in people with Acute on Chronic Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Acute on chronic liver failure patients with HVPG (Hepatic Venous Pressure Gradient) ≥ 12 mmHg + No/small esophageal varices who present to the Department of Hepatology at Institute of Liver and Billiary Sciences, who meet the inclusion criteria and who provide informed consent. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute on Chronic Liver Failure
- What is being tested?
- Carvedilol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteIndia
- Study dates
- 1 Oct 2015to 1 Jul 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute on Chronic Liver Failure as per APASL (Asian Pacific Association of Study of Liver Disease) criteria.
- 18-75 years
- HVPG ≥ 12 + No/Small Esophageal varices
Who cannot join
- Bradycardia (HR < 60/ min)
- Hypotension
- Asthma
- LVF
- AKI (Acute Kidney Injury), (S.creat >1.5)
- Refractory ascites
Show all 14Show fewer
- SBP (Spontaneous Bacterial Peritonitis)
- Pregnancy or Lactation
- Past history of EVL or EST
- Significant cardio - pulmonary co-morbidity
- PVT
- Presence of grades 3-4 hepatic encephalopathy (HE)
- Patients going for liver transplant in next 12 weeks
- No consent
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: Efficacy of Nonselective Beta Blockers vs Placebo in Patients With Acute-on-chronic Liver Failure With Small/ no Esophageal Varices
Acute on chronic liver failure patients with HVPG (Hepatic Venous Pressure Gradient) ≥ 12 mmHg + No/small esophageal varices who present to the Department of Hepatology at Institute of Liver and Billiary Sciences, who meet the inclusion criteria and who provide informed consent.
- Conditions
- Acute on Chronic Liver Failure
- Being tested
- Carvedilol, Placebo
- Medical subject headings
- Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarvedilolDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Carvedilol | Experimental | Tab Carvedilol 3.125 mg twice daily followed by 6.25 mg BD and finally 12.5 mg BD if SBP > 90 mmHg and HR >55/min Receives: Drug: Carvedilol |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality in both groups
Measured: 28 days
Secondary outcomes (17)
Number of patients with development or progression of esophageal varices in both groups.
Measured: 3 Months
Number of patients with reduction in hepatic venous pressure gradient (HVPG) in both groups.
Measured: 3 Months
Number of patients with regression in esophageal varices in both groups.
Measured: 3 Months
Number of patients with improvement in Liver severity scores in both groups.
Measured: 28 days
Number of patients with improvement in Liver severity scores in both groups.
Measured: 60 days
Number of patients with improvement in Liver severity scores in both groups.
Measured: 3 months
Number of patients with development of adverse events in both groups in both groups.
Measured: 28 days
Number of patients with development of adverse events in both groups in both groups.
Measured: 2 months
Number of patients with development of adverse events in both groups in both groups.
Measured: 3 Months
Number of patients who will develop esophageal variceal bleeding in both groups
Measured: 28 days
Number of patients who will develop esophageal variceal bleeding in both groups
Measured: 2 Months
Number of patients who will develop esophageal variceal bleeding in both groups
Measured: 3 Months
Development of complications in both groups
AKI,Pneumonia,SBP and other infections
Measured: 28 days
Development of complications in both groups
AKI,Pneumonia,SBP and other infections
Measured: 2 months
Development of complications in both groups
AKI,Pneumonia,SBP and other infections
Measured: 3 months
Mortality in both groups
Measured: 2 months
Mortality in both groups
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study start1 Oct 2015
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
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 Acute on Chronic Liver FailureStudies 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
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Sumeet Kainth, MD, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583698
- Sponsor's protocol ID
- ILBS-ACLF-005
- Status last verified
- Nov 2017
- First submitted
- 21 Oct 2015
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Kumar M, Kainth S, Choudhury A, Maiwall R, Mitra LG, Saluja V, Agarwal PM, Shasthry SM, Jindal A, Bhardwaj A, Kumar G, Sarin SK. Treatment with carvedilol improves survival of patients with acute-on-chronic liver failure: a randomized controlled trial. Hepatol Int. 2019 Nov;13(6):800-813. doi: 10.1007/s12072-019-09986-9. Epub 2019 Sep 20.
PubMed 31541422
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nonselective Beta Blockers vs Placebo in Patients With Acute-on-chronic Liver Failure With Small/ no Esophageal Varices
- ClinicalTrials.gov ID
- NCT02583698
- Acronym / sponsor ID
- ILBS-ACLF-005
- Conditions
- Acute on Chronic Liver Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 22 Oct 2015 (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.
Acute on chronic liver failure patients with HVPG (Hepatic Venous Pressure Gradient) ≥ 12 mmHg + No/small esophageal varices who present to the Department of Hepatology at Institute of Liver and Billiary Sciences, who meet the inclusion criteria and who provide informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carvedilol | Experimental | Drug: CarvedilolTab Carvedilol 3.125 mg twice daily followed by 6.25 mg BD and finally 12.5 mg BD if SBP > 90 mmHg and HR >55/min |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute on Chronic Liver Failure as per APASL (Asian Pacific Association of Study of Liver Disease) criteria.
- 18-75 years
- HVPG ≥ 12 + No/Small Esophageal varices
Key exclusion criteria (14 listed)
- Bradycardia (HR < 60/ min)
- Hypotension
- Asthma
- LVF
- AKI (Acute Kidney Injury), (S.creat >1.5)
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 |
|---|---|---|
| Carvedilol | Drug | Carvedilol |
| Placebo | Drug | placebo |
Primary outcome
Mortality in both groups
Time frame: 28 days
17 secondary outcomes
Number of patients with development or progression of esophageal varices in both groups.
Time frame: 3 Months
Number of patients with reduction in hepatic venous pressure gradient (HVPG) in both groups.
Time frame: 3 Months
Number of patients with regression in esophageal varices in both groups.
Time frame: 3 Months
Number of patients with improvement in Liver severity scores in both groups.
Time frame: 28 days
Number of patients with improvement in Liver severity scores in both groups.
Time frame: 60 days
Number of patients with improvement in Liver severity scores in both groups.
Time frame: 3 months
Number of patients with development of adverse events in both groups in both groups.
Time frame: 28 days
Number of patients with development of adverse events in both groups in both groups.
Time frame: 2 months
Number of patients with development of adverse events in both groups in both groups.
Time frame: 3 Months
Number of patients who will develop esophageal variceal bleeding in both groups
Time frame: 28 days
Number of patients who will develop esophageal variceal bleeding in both groups
Time frame: 2 Months
Number of patients who will develop esophageal variceal bleeding in both groups
Time frame: 3 Months
Development of complications in both groups
Time frame: 28 days
Development of complications in both groups
Time frame: 2 months
Development of complications in both groups
Time frame: 3 months
Mortality in both groups
Time frame: 2 months
Mortality in both groups
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Derived from this study: PubMed 31541422Kumar M, Kainth S, Choudhury A, Maiwall R, Mitra LG, Saluja V, Agarwal PM, Shasthry SM, Jindal A, Bhardwaj A, Kumar G, Sarin SK. Treatment with carvedilol improves survival of patients with acute-on-chronic liver failure: a randomized controlled trial. Hepatol Int. 2019 Nov;13(6):800-813. doi: 10.1007/s12072-019-09986-9. Epub 2019 Sep 20.
Related trials for Acute on Chronic Liver Failure
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Not yet recruiting
Very Low-volume Plasma Exchange in ACLF
Acute on Chronic Liver Failure (ACLF)
Recruiting
A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.
Acute-on-Chronic Liver Failure (ACLF), Liver Cirrhosis
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.
Dr Sumeet Kainth, MD principal investigator
Institute of Liver and Biliary Sciences, India
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 in people with Acute on Chronic Liver Failure, 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 3 inclusion and 14 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: finished, as of the sponsor's last update on 4 Jun 2019. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality in both groups (time frame: 28 days). 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 NCT02583698, 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 4 Jun 2019.