Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)
NCT07601425 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-05-22
Summary
This is a 2-part study evaluating ATV-1601 in participants with moderate to severe HHT. Part 1 is a randomized, double-blind, placebo-controlled study evaluating 3 dosing regimens of ATV-1601. Patients completing Part 1 may participate in the Part 2 open-label extension to receive ATV-1601.
Conditions
- Hereditary Hemorrhagic Telangiectasia (HHT)
- Osler Weber Rendu Disease
Interventions
- DRUG
-
ATV-1601
Administered orally, daily
- DRUG
-
Administered orally, daily
Sponsors & Collaborators
-
Atavistik Bio, Inc
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2027-12-31
- Completion
- 2030-03-31
- FDA Drug
- Yes
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