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Drug could offer alternative to liver transplant for rare bleeding disorder

NCT ID NCT00843440

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a drug called bevacizumab in 25 adults with hereditary hemorrhagic telangiectasia (HHT) who had severe liver issues and high heart output. The goal was to see if the drug could improve heart function and reduce the need for a liver transplant, which requires lifelong immune-suppressing drugs. Results were measured at 3, 6, and 12 months.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

25 people

The number who actually took part.

Start date

Mar 2009

Finished

Mar 2012

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 70 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: * General criteria: * Age ≥ 18 years and \< 70 years * Subjects must have given their free and enlightened consent and have signed the consent form. * HHT related criteria * Patients monitored for clinically confirmed HHT disease. * Patients with severe liver involvement in relationship with the HHT disease * Patients with a high cardiac output on ultrasound. * Associated disease related criteria * Blood: neutrophil ≥ 1.0x109 / L and platelets ≥ 100x109 / L. * INR (International Normalized Ratio) ≤ 1.5 (except for patients on anticoagulants) and TCA ≤ 1.5 x upper limit of the standard laboratory * Renal function: creatinine ≤ 1.25 x upper limit of the standard laboratory. Patients who proteinuria to strip ≥ 2 + will have control of the Proteinuria of 24 hours to be ≤ 1g / 24 hours Exclusion Criteria: * • General criteria * Women who are pregnant or liable to become pregnant in the course of the trial. * Patients who have reached their majority but who are protected by the terms of the law (French public health code). * Refusal to give enlightened consent. * Patients who are not affiliated to a health insurance regime • Criteria for the medical history * Patients in whom the diagnosis of HHT disease has not been confirmed. * The presence of atrial fibrillation on the electrocardiogram at the inclusion. * The presence of cerebral arteriovenous malformations on the angioMRI done in the year prior to inclusion. * Existence of diverticulitis of the colon or sigmoid * Thrombosis within 6 months before inclusion * Infectious disease treated by antibiotics and unresolved at inclusion. * Patients with blood pressure that is not being controlled at the time of inclusion (systolic blood pressure\> 150 mmHg and / or diastolic\> 100 mmHg) with or without treatment. Patients who have high blood pressure can be included when the blood pressure numbers have been standardized by appropriate medical treatment. • Surgical criteria * Major surgery (including open biopsy) or severe trauma within 28 days preceding the start of treatment. • Medical treatments * Current or recent use of non steroidal anti-inflammatory drugs or antiplatelet therapy 10 days before the first administration of Bevacizumab. * Use of oral or parenteral anticoagulants or thrombolytic agents within 28 days preceding inclusion (anticoagulants given prophylactically are permitted). * Participation in another clinical trial within 28 days preceding inclusion. * Vaccination with live vaccines or against yellow fever during the treatment period. * Administration of phenytoin (Di-hydan ® DILANTIN ®) during the treatment period. • Allergy * Hypersensitivity to the active substance or any of its excipients. * Hypersensitivity to products made from Chinese hamster ovary (CHO) cells or to any other human or humanized recombinant antibodies.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Hospices Civils de Lyon

    Lyon, France

More trials for these conditions

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