Evaluation of the Efficacy and Safety of THRV-1268 in Participants With Long QT Syndrome Type 2 (LQTS2) and Type 3 (LQTS3)
Sponsor: Thryv Therapeutics, Inc. • ClinicalTrials.gov ID: NCT07277582
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The goal of this clinical trial is to learn whether the study drug THRV-1268 can safely and effectively shorten the QT interval in people diagnosed with Long QT Syndrome Type 2 (LQTS 2) and Long QT Syndrome Type 3 (LQTS 3). The study will also learn about the safety and tolerability of THRV-1268 at different doses. The main questions this study aims to answer are: Does THRV-1268 reduce the QTc interval (a measure of the heart's electrical recovery time)? What side effects or medical problems occur when participants take THRV-1268? Which dose of THRV-1268 works best and is safest? Participants will: Complete a 3-week observation period with ECG and Holter monitoring to establish baseline QTc measurements Take THRV-1268 twice daily at two dose levels for 6 weeks (Part A) or be randomly assigned to a dose group for 6 weeks (Part B - cohort 1) Have clinic visits and tests to monitor safety and changes in their heart rhythm May continue taking THRV-1268 for up to 1 year for ongoing safety and efficacy evaluation Researchers will compare changes in QTc over time and evaluate side effects to determine whether THRV-1268 can help reduce the risk of abnormal heart rhythms and sudden cardiac events in people with LQTS 2 and LQTS 3.
Interventions
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baseline lead-in
(Other)
Participants will undergo a 3 weeks run-in baseline
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THRV-1268
(Drug)
THRV-1268 50 mg bid (total daily 100 mg) for 6 weeks
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THRV-1268
(Drug)
THRV-1268 100 mg bid (total daily 200 mg) for 6 weeks
Eligibility criteria
Conditions
Locations
- Honor Health Research and Innovation Institute — Scottsdale, Arizona, United States
- University of California San Francisco — San Francisco, California, United States
- University of Illinois Chicago — Chicago, Illinois, United States
- Heart Center Clinical Research Program | MGH — Boston, Massachusetts, United States
- University of Michigan — Arbor, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- NYU Langone Health — New York, New York, United States
- Wilmington Health — Wilmington, North Carolina, United States
- Oregon Health & Science University — Portland, Oregon, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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