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Monoclonal Antibodies
Bevacizumab for Hereditary Hemorrhagic Telangiectasia
Phase 2
Recruiting
Research Sponsored by Hanny Al-Samkari, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Red blood cell transfusion and/or iron infusion dependence, as defined by a hematologic support score (HSS) of ≥3 in the 3 months prior to consent
Age ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 weeks
Awards & highlights
Study Summary
This trial is studying bevacizumab to see how well it works in treating patients with HHT.
Who is the study for?
This trial is for adults over 18 with Hereditary Hemorrhagic Telangiectasia (HHT), experiencing chronic bleeding and iron deficiency anemia. Participants must meet at least two Curacao criteria, require blood transfusions or iron infusions, and have stable organ/marrow function. Women of childbearing age and men must agree to use contraception.Check my eligibility
What is being tested?
The study tests Bevacizumab's effectiveness in treating HHT-related chronic bleeding and anemia by inhibiting VEGF activity, which is believed to reduce the formation of fragile blood vessels that lead to excessive bleeding in HHT patients.See study design
What are the potential side effects?
Bevacizumab may cause side effects such as allergic reactions, increased risk of infections due to suppressed immune response, potential bleeding issues, high blood pressure, fatigue, headaches, and possibly digestive disturbances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have needed blood transfusions or iron infusions regularly in the last 3 months.
Select...
I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in hematologic support score from pretreatment to maintenance
Secondary outcome measures
Average Maintenance Epistaxis Severity Score
Difference in the individual patient intravenous iron infusion requirement
Difference in the individual patient mean hemoglobin
+2 moreSide effects data
From 2015 Phase 4 trial • 45 Patients • NCT0203642422%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
cranial nerve VI palsy
4%
bradycardia
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex
Trial Design
1Treatment groups
Experimental Treatment
Group I: BevacizumabExperimental Treatment1 Intervention
The research study procedures include: screening for eligibility, pretreatment period, study treatment, end-of-study visit, and follow-up visit. Each period consists of 12 weeks, for a total of 36 weeks.
Pretreatment Period:Hematologic Support: iron transfusions and red cell transfusions as determined by study doctor.
Induction Period (first 3 months of bevacizumab treatment):
Hematologic Support: iron transfusions and red cell transfusions as determined by study doctor.
Bevacizumab: once every 2 weeks via intravenous infusion for up to 12 weeks.
Maintenance Period (second 3 months of bevacizumab treatment):
Hematologic Support: Iron transfusions and red cell transfusions as determined by study doctor.
Bevacizumab: once every 4 weeks via intravenous infusion for up to 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
Find a Location
Who is running the clinical trial?
Hanny Al-Samkari, MDLead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have coughed up blood recently.My high blood pressure is not well-managed.I have not had endoscopy for GI bleeding or nasal surgery for nosebleeds in the last 3 months.I have needed blood transfusions or iron infusions regularly in the last 3 months.My organs and bone marrow are working well.I have not taken oral iron supplements in the last 2 weeks.I am 18 years old or older.I am scheduled for surgery within 6 months or had surgery less than a month ago.I have been on a stable dose of hormone therapy for a set period before giving consent.I have been on a stable dose of my medication for a while.You have had allergic reactions to bevacizumab in the past.I have a serious or non-healing wound, ulcer, or bone fracture.I do not have any unmanaged ongoing illnesses.I have been diagnosed with a type of anemia that affects my blood cell production.I am not willing to receive blood or iron transfusions as per the study's protocol.I have been diagnosed with hereditary hemorrhagic telangiectasia based on the Curacao criteria.I can take care of myself but might not be able to do heavy physical work.I have a history of significant blood clotting disorders.You have a lot of protein in your urine.I have not taken certain medications recently.
Research Study Groups:
This trial has the following groups:- Group 1: Bevacizumab
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the safety profiles associated with Bevacizumab usage?
"The safety of Bevacizumab was assessed at 2 due to the current phase two status, indicating that there is limited data available in terms of its efficacy but some evidence suggesting it can be used safely."
Answered by AI
What is the current enrollment capacity for this clinical experiment?
"Affirmative. The data on clinicaltrials.gov verifies that this medical trial is currently recruiting participants, which was first advertised on November 23rd 2020 and most recently adjusted July 1st 2021 .The study requires 20 individuals to be recruited from one location."
Answered by AI
Is there still availability for participants to join this research endeavor?
"Affirmative. The data published on clinicaltrials.gov verifies that this medical trial is currently enrolling volunteers; it was initially posted to the website on November 23rd 2020 and revised most recently on July 1st 2021. This study seeks out 20 participants from a single site."
Answered by AI
Could you provide a catalogue of previous research studies involving Bevacizumab?
"At present, there are 89 Phase 3 trials and 355 active studies for Bevacizumab spread across 17014 different locations with many of these trials located in Taipei, Taiwan."
Answered by AI
What maladies and conditions can Bevacizumab be used to treat?
"Bevacizumab can be utilized to treat recurrent platinum-sensitive primary peritoneal cancer, malignant neoplasms, and stage IV epithelial ovarian cancers which have undergone initial surgical resection."
Answered by AI
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