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โ† Trials
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A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias

RecruitingPhase 1Ages 18 Years - 75 YearsAllCRISPR Therapeutics AG
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In plain words

What the trial is, and whether it could suit you

This is a single-arm, open-label, multicenter, ascending dose Phase 1 trial that will enroll participants 18 to 75 years of age with dyslipidemias that are refractory to available treatments.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: 1. Age of โ‰ฅ18 and โ‰ค75 years at the time of signing the informed consent. 2. Able to provide written informed consent. 3. Participants diagnosed with persistent dyslipidemias defined by TG โ‰ฅ150 mg/dL - and LDL-C โ‰ฅ70 mg/dL in participants with ASCVD, or LDL-C โ‰ฅ70 or 100mg/dL in participants with or without ASCVD respectively, or TG โ‰ฅ500 mg/dL. 4. Refractory to the maximal intensity or MTD of standard of care lines of lipid-lowering therapies available through routine clinical care, for at least 12 weeks prior to screening 5. Female participants must be postmenopausal or surgically sterile. 6. All male participants and their female partners must agree to the use of an acceptable method of effective contraception for the duration of the study. Exclusion Criteria: 1. Participants with familial chylomicronemia syndrome (FCS). Some exceptions may apply. 2. Evidence of liver disease, defined as but not limited to: LFTS \>2 ร— upper limit of normal (ULN), or total bilirubin \>2 ร— ULN, or INR \>1.5 ร— ULN, or liver stiffness measured by liver elastography 3. Abnormal or compromised function of kidney, heart, blood or liver. 4. Acute coronary syndrome event or stroke within 24 weeks prior to Day 1. Acute pancreatitis within 12 weeks prior to Day 1. 5. Current use or use within 365 days from Day 1 of any hepatocyte-targeted small interfering RNA (except inclisiran). 6. Positive serology for HIV, hepatitis B or hepatitis C (antibody, surface antigen orNAT). Serology consistent with prior immunization will be eligible for the trial. 7. Any prior malignancy within the past 5 years, or current malignancy (exceptions for resected or removed basal cell carcinoma, squamous cell carcinoma in situ and carcinoma in situ of the cervix or breast). 8. Women of childbearing potential. Note: Other protocol defined Inclusion/Exclusion criteria may apply. Note: The inclusion and exclusion criteria listed represent the global protocol. Additional or modified eligibility criteria may apply in certain countries in accordance with local regulatory and ethics committee requirements and the approved country-specific protocol.
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What it tests

  • CTX310
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Where

17 sites
Integrity Clinical Research
Hialeah, United States
Jacksonville Center for Clinical Research
Jacksonville, United States
Flourish Orlando
Orlando, United States
United Medical Research
Port Orange, United States
University of Rochester
Rochester, United States
Duke Early Phase Clinical Research
Durham, United States
Peters Medical Research
High Point, United States
Oregon Health & Science University (OHSU)
Portland, United States

โ€ฆand 9 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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