No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Atavistik Bio, Inc · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* 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 u…
Inclusion Criteria:
* 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
* 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
Exclusion Criteria:
* 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
Additional Criteria for Open-Label Extension:
* Participants must complete the double-blind treatment period (Part 1)
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