Phase 1 / Phase 2: testing ATV-1601 for Hereditary Hemorrhagic Telangiectasia (HHT)
This is a 2-part study evaluating ATV-1601 in participants with moderate to severe HHT. Part 1 is a randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study evaluating 3 dosing regimens of ATV-1601.
Official registry: https://clinicaltrials.gov/study/NCT07601425 · Atavistik Bio, Inc · enrollment listed as 100
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are ATV-1601, or Placebo. The registry lists allocation as randomized. This is a 2-part study evaluating ATV-1601 in participants with moderate to severe HHT.
They plan to enroll about 100 people at 10 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study of ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)
Interventions: ATV-1601, Placebo
Primary outcome (registry wording): Part 1: Safety and tolerability
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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
- Adequate hematologic, renal, and hepatic function per protocol-defined laboratory criteria
- Use highly effective contraception during the study and for a protocol-defined period after last dose
Who the registry excludes
- 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)
- Recent (within 6 weeks) major surgery or local ablative procedures, or procedures on nasal telangiectasias
- Prior AKT inhibitor
- Pregnant or breastfeeding women
Contact
No central phone on the registry card. Use the official listing to reach a site.
Sites listed on ClinicalTrials.gov
10 listed- Arizona Pulmonary Specialists — Phoenix, Arizona (recruiting)
- University of California, San Diego — San Diego, California (recruiting)
- Augusta University Medical Center — Augusta, Georgia (recruiting)
- Innovative Hematology — Indianapolis, Indiana (recruiting)
- Massachusetts General Hospital — Boston, Massachusetts (recruiting)
- Mayo Clinic — Rochester, Minnesota (recruiting)
- Washington University in St. Louis — St Louis, Missouri (recruiting)
- University of North Carolina — Chapel Hill, North Carolina (recruiting)
- University of Utah Health Sciences Center — Salt Lake City, Utah (recruiting)
+ 1 sites outside the US on the same record
FAQ about this NCT record
Is NCT07601425 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07601425?
Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07601425?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary