Bevacizumab In Hereditary Hemorrhagic Telangiectasia (NCT04404881)

🧪 Interventions in This Study

• Bevacizumab (Avastin®) (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. A clinical diagnosis of "possible/suspected" or "definite" hereditary hemorrhagic telangiectasia, as defined by presence of 2 or more of the Curacao criteria (spontaneous and recurrent epistaxis, telangiectasias at characteristic sites, visceral arteriovenous malformations (AVMs), first degree relative with HHT).
2. Age ≥18 years. Because no dosing or adverse event data are currently available on the use of bevacizumab for HHT in participants \<18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
3. 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. HSS is calculated by dividing the total milligrams of elemental iron infused by 250 and adding to this the number of red cell units transfused.
4. ECOG performance status ≤2 (see Appendix B).
5. Participants must have adequate organ and marrow function as defined below:
6. leukocytes ≥2,000/mcL
7. absolute neutrophil count ≥1,000/mcL
8. platelets ≥50,000/mcL
9. AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN\*
10. creatinine ≤ 2.5 mg/dL OR
11. glomerular filtration rate (GFR) ≥45 mL/min/1.73 m2 \*Except AST and/or ALT elevation related to HHT-associated hemolytic anemia or liver AVMs, in the opinion of the investigator. Bilirubin thresholds are not included as mild chronic hyperbilirubinemia is common in HHT, likely related to subclinical hemolysis in AVMs. Patients with clinically advanced liver disease should be excluded from participation.
12. The effects of bevacizumab on the developing human fetus are unknown. For this reason and because anti-angiogenic agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Women should additionally use adequate contraception for the 6 months after discontinuation of bevacizumab. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of bevacizumab administration.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• Massachusetts General Hospital — Boston, Massachusetts

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Hereditary Hemorrhagic Telangiectasia

• DIAG723 in Adults With Hereditary Hemorrhagic Telangiectasia — Camperdown, New South Wales
• CHORUS - Comprehensive HHT Outcomes Registry of the United States (Formerly OUR HHT Registry) — Toronto, Ontario
• Comprehensive HHT Outcomes Registry of the United States (CHORUS) — Birmingham, Alabama
• A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT) — Birmingham, Alabama
• Effects of Pazopanib on Hereditary Hemorrhagic Telangiectasia Related Epistaxis and Anemia (Paz) — Los Angeles, California

Explore by condition: All Hereditary Hemorrhagic Telangiectasia clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.