Bevacizumab In Hereditary Hemorrhagic Telangiectasia

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Hanny Al-Samkari, MD
Study ID
NCT04404881
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Hereditary Hemorrhagic Telangiectasia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab (Avastin®) — DRUG
    * Induction Period (first 3 months of bevacizumab treatment): \-- Bevacizumab: once every 2 weeks via intravenous infusion for up to 12 weeks. * Maintenance Period (second 3 months of bevacizumab treatment): * Bevacizumab: once every 4 weeks via intravenous infusion for up to 12 weeks.

Study Details

This research study is studying to see whether bevacizumab may treat chronic bleeding and iron deficiency anemia in Hereditary Hemorrhagic Telangiectasia (HHT). Hereditary Hemorrhagic Telangiectasia (HHT) is a disorder that causes abnormal blood vessel formation. In HHT, there is a mutation in the TGF-β pathway, which results in an increase of vascular endothelial growth factor (VEGF) levels. An increase in VEGF levels can result in poorly formed blood vessels that have a higher rate of bleeding than normal blood vessels. Bevacizumab is designed to block VEGF activity. It is believed that targeting increased VEGF levels may be able to treat HHT. This research study involves the following study drug: \- Bevacizumab

Key Dates

First listed
May 28, 2020
Start date
Nov 23, 2020
Status verified
Apr 2026
Primary completion
Mar 2, 2026
Completion
Feb 1, 2027

Study Design

Enrollment
33 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab
    * 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.

Primary Outcome Measure

Change in hematologic support score from pretreatment to maintenance [ Time Frame: 36 Weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02115-

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By research site
Massachusetts General Hospital· Boston, MA

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