BABH Study: Efficacy and Safety of Bevacizumab on Severe Bleedings Associated With Hemorrhagic Hereditary Telangiectasia (HHT).

• Register: ClinicalTrials.gov
• Last refreshed on: 26 October 2021
• Main ID: NCT03227263
• Date of registration: 21/07/2017
• Prospective Registration: Yes
• Primary sponsor: Hospices Civils de Lyon
• Public title: BABH Study: Efficacy and Safety of Bevacizumab on Severe Bleedings Associated With Hemorrhagic Hereditary Telangiectasia (HHT). BABH
• Scientific title: BABH Study: Efficacy and Safety of Bevacizumab on Severe Bleedings Associated With Hemorrhagic Hereditary Telangiectasia (HHT). A National, Multicenter Phase III Study
• Date of first enrolment: September 28, 2017
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03227263
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: DUPUIS-GIROD, MD
• Affiliation: Hospices Civils de Lyon

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age = 18 years.

- Patients who have given their free informed and signed consent.

- Patients affiliated to a social security scheme or similar.

- Patients monitored for clinically confirmed HHT (presence of at least three Curaçao
criteria) and / or with molecular biology confirmation.

- Blood transfusions with the requirement for at least 4 units of blood in the 3-month
period before study enrollment, related to epistaxis or digestive bleeding.

Exclusion Criteria:

- Women who are pregnant or nursing (lactating), women of child-bearing potential
without reliable contraception during the treatment and for at least 6 months after
the last dose.

- Patients who are protected adults under the terms of the law (French Public Health
Code).

- Refusal to consent.

- Patients for whom the diagnosis of HHT has not been confirmed clinically and / or by
molecular biology study.

- Active infection and/or fever>38°C

- Participation in another clinical trial within 28 days prior to inclusion.

- Hypersensitivity to the active substance or to any of the excipients.

- Known hypersensitivity to products of Chinese hamster ovary cells (CHO) or other
recombinant human or humanized antibodies.

- Patients who have taken Avastin ® intravenously in the 6 months prior to inclusion.

- Patients who have had a therapeutic endoscopy for gastrointestinal bleeding or ENT
surgery for epistaxis will have to wait at least 3 months less after treatment to be
included if bleeding persists.

- Patients who had a surgery in the month prior inclusion or planned surgery within 6
months

- Severe peripheral arterial disease with ulcerations

- Unhealed wound

- Thrombosis in the 6 months prior to inclusion

- Anticoagulant treatment

- Uncontrolled high blood pressure



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Telangiectasia, Hereditary Hemorrhagic

Rendu Osler Disease

Intervention(s)

Drug: Bevacizumab

Drug: sodium chloride 0.9%

Primary Outcome(s)

number of red blood cell transfusions [Time Frame: 6 months]

Secondary Outcome(s)

digestive vascular malformations [Time Frame: 6 months]

epistaxis frequency [Time Frame: 3 months before treatment up to 6 months from the inclusion]

quality of life (SF36). [Time Frame: 3 months]

severity epistaxis score (ESS). [Time Frame: 6 months.]

hemoglobin [Time Frame: 3 months]

quality of life (SF36). [Time Frame: 6 months]

To evaluate pharmacokinetics of bevacizumab dose [Time Frame: 2 hours after the first treatment infusion]

adverse events [Time Frame: up to 6 months]

severity epistaxis score (ESS). [Time Frame: 3 months]

hemoglobin [Time Frame: 6 months]

To evaluate pharmacokinetics of bevacizumab dose [Time Frame: Before each 6 infusions]

duration of nosebleeds [Time Frame: 3 months before treatment up to 6 months from the inclusion]

Secondary ID(s)

2017-001031-39

69HCL17_0018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors