Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAtavistik Bio, Inc
About this trial
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.
Eligibility criteria
Qualifiers
Ability to provide informed consent prior to any study-specific procedures
Confirmed diagnosis of hereditary hemorrhagic telangiectasia (HHT) based on Curaçao criteria
Moderate to severe HHT with an ESS ≥ 4
Anemia at Screening and/or requirement for at least 1 red-cell unit (RUE) in the previous 6 months
Disqualifiers
Clinically significant abnormalities of glucose metabolism including diagnosed Type 1 or uncontrolled Type 2 diabetes
Chronic cardiac disease, or cardiac rhythm abnormalities
History of significant cardiovascular, hepatic, renal, or hematologic disease not related to HHT that may confound study results
Use of prohibited concomitant medications within a protocol-defined washout period prior to first dose (including strong CYP modulators and certain herbal supplements)
Trial design
Treatments tested in this trial
- ATV-1601
- Placebo
Treatment groups
100 Participants
are divided into 4 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov