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Could a simple pill combo stop deadly rebleeds in cirrhosis?

NCT ID NCT07465471

Disease control Sponsor: Institute of Liver and Biliary Sciences, India Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding midodrine to the standard drug carvedilol can prevent early rebleeding in people with cirrhosis who have had a variceal bleed. About 210 high-risk patients will receive either carvedilol alone or carvedilol plus midodrine for 6 weeks. The goal is to see if the combination reduces the chance of another bleed and improves survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Carvedilol and midodrine
What this could lead to
If it works, this could offer a simple, oral drug combination to reduce dangerous early rebleeding in cirrhosis patients, potentially improving survival without needing complex procedures.
What could go wrong
This is a small, early-stage trial (210 people) that hasn't started recruiting yet. The benefit may be modest, and side effects like low blood pressure or slow heart rate could limit use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 210 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Consecutive patients of cirrhosis with high-risk acute variceal bleed (Child-Pugh class B \> 7 with active bleeding at initial endoscopy or Child-Pugh class C \< 14 points). Exclusion Criteria: 1. Age less than 18 years or \> 75 years. 2. HR \< 60/ min and BP \< 100/60 mm Hg 3. Child-Pugh's score \<8 and \>13. 4. MELD score \>30 and serum lactate \>12mmol/L. 5. Refractory variceal bleed. 6. Preemptive TIPS or previous Porto-systemic shunt or TIPS. 7. Non-selective Beta blocker/carvedilol / midodrine treatment in last 5 days. 8. Acute kidney injury - HRS. 9. Uncontrolled Hypertension (BP \> 140/90 mmHg), heart block, congestive heart failure. 10. Contraindication to NSBB (HR\<60/min, BP\<90/60mmHg, bronchial asthma). 11. Hepatocellular carcinoma (outside Milan criteria), extrahepatic malignancy. 12. Pregnant women. 13. Bleeding from isolated gastric or ectopic varices.

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Liver cirrhosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Institute of Liver and Biliary Sciences

    New Delhi, National Capital Territory of Delhi, 110070, India

More trials for these conditions

Other studies related to the condition(s) this trial covers.