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Tests treatment safety and results for Long QT Syndrome (LQTS) 2
Official title Evaluation of Efficacy and Safety of THRV-1268 in Long QT Syndrome Type 2 (LQTS 2)
ClinicalTrials.gov ID: NCT07277582
What this study is testing
What is THRV-1268?
THRV-1268 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for long qt syndrome (lqts) 2.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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). The study will also learn about the safety and tolerability of THRV-1268 at different doses.
- Phase 3: a large, late-stage study
- Time commitment: about 1 year
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 and older
You may be able to join if
- Male and female participants over 15 years of age at Screening (at least the first 5 participants enrolled in Part A must be 18 years of age or...
- LQTS 2 genotype: Demonstration of KCNH2 mutation by clinical laboratory test result that is autosomal dominant (heterozygous) and considered to be...
- QTcF interval \>480 ms and ≤600 ms based on Screening ECG.
- Body weight of at least 45 kg with body mass index between 18.0 and 40.0 kg/m2, inclusively at Screening.
- Male and female participants of childbearing potential must agree to use highly effective contraception throughout the duration of the study.
You likely can't join if
- Within 2 months prior to Screening, Participant has a history of an aborted cardiac arrest, ICD implantation, or syncopal episode due to a...
- History of structural or functional cardiovascular disease, myocardial infarction or stroke or transient ischemic attack (TIA), atrial fibrillation...
- Active or known liver disease.
- Active or past oncologic disease, except for non-melanoma skin cancer.
- Advanced pulmonary disease that requires more than a steroid inhaler.
- Pulmonary artery hypertension.
See the full eligibility criteria
- Male and female participants over 15 years of age at Screening (at least the first 5 participants enrolled in Part A must be 18 years of age or older).
- LQTS 2 genotype: Demonstration of KCNH2 mutation by clinical laboratory test result that is autosomal dominant (heterozygous) and considered to be pathologic or likely pathologic can be included after approval from the...
- QTcF interval \>480 ms and ≤600 ms based on Screening ECG.
- Body weight of at least 45 kg with body mass index between 18.0 and 40.0 kg/m2, inclusively at Screening.
- Male and female participants of childbearing potential must agree to use highly effective contraception throughout the duration of the study.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Participants age 15 to \<18 years capable of providing signed assent.
- Within 2 months prior to Screening, Participant has a history of an aborted cardiac arrest, ICD implantation, or syncopal episode due to a ventricular arrhythmia. Participants can be enrolled after the 2-month period...
- History of structural or functional cardiovascular disease, myocardial infarction or stroke or transient ischemic attack (TIA), atrial fibrillation or atrial flutter, heart failure, bundle branch block, angina pectoris...
- Active or known liver disease.
- Active or past oncologic disease, except for non-melanoma skin cancer.
- Advanced pulmonary disease that requires more than a steroid inhaler.
- Pulmonary artery hypertension.
- Is pregnant, lactating, or breastfeeding, or planning to become pregnant.
- Has a positive result for the urine pregnancy test at the Screening Visit or the serum pregnancy test at the Day -7 Visit.
- Clinically significant abnormal findings on the physical examination or medical history during Screening or Day -21 as deemed by the investigator.
- Has experienced an acute illness that has resolved in less than 14 days before the first study drug dose or has had a major illness or hospitalization within 1 month before the first study drug dose.
- Has a recent history of alcohol or substance abuse that would pose a risk for the participant's safety and compliance with the study protocol, in the opinion of the investigator.
- Has a pacemaker or ICD that is actively used for ventricular pacing.
- Is currently taking or anticipates the use of any restricted drugs
- Is considering or scheduled to undergo any elective surgical procedure during the study.
- Current participation or recent within 1 month of participating in another treatment clinical study.
- Screening Visit diastolic blood pressure \>95 mm Hg, systolic blood pressure \ 150 mm Hg.
- At Screening, if the 12-lead triplicate ECG demonstrates any of the following: PR \>280 ms; QRS \>110 ms, or QTcF \>600 ms or ≤480 ms; bundle branch block or significant ST-T wave abnormalities or flat T waves that...
- Atrial pacing rate set to \>80 bpm in those participants with atrial pacing.
- Abnormal renal function with an eGFR of \<70 mL/min/1.73 m2 (with eGFR calculated by the CKD-EPI formula at Screening). One retest of the exclusionary eGFR value is allowed at the discretion of the investigator.
- Has abnormal liver function tests:
- ALT, AST, GGT, ALP \> 1.5 the ULN.
- Total bilirubin \>ULN.
- INR \>1.2 ULN (requires measurement of prothrombin time (PT)).
- Has clinically significant abnormality in serum chemistry values at Screening for hemoglobin, potassium, magnesium, or calcium levels as determined by the investigator. A single repeat test and/or correction of abnormal...
- Any participant, who, for any reason, is deemed by the investigator to be inappropriate for this study or has any condition which would confound or interfere with the evaluation of the safety, side effects, or how well...
- Consumes on average more than 21 standard alcoholic drinks per week in men and 14 standard drinks per week in women over the last 2 years.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- San Francisco, California, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- Wilmington, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 15 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; San Francisco, California, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; Rochester, Minnesota, United States; Wilmington, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.