Drug could offer alternative to liver transplant for rare bleeding disorder
NCT ID NCT00843440
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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25 people
The number who actually took part.
- Start date
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Mar 2009
- Finished
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Mar 2012
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Hospices Civils de Lyon
Lyon, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.