A Safety and Tolerability Study Evaluating CTX310 in Subjects With Refractory Dyslipidemias

Phase 1

Recruiting

• Conditions: Refractory Dyslipidemias; Cardiovascular - Other cardiovascular diseases; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12623000809639
• Lead Sponsor: CRISPR Therapeutics AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-27
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Subjects diagnosed with persistent dyslipidemia
2. Subjects must be refractory to the maximum tolerated doses of standard of care lines of treatment
3. Female subjects must be postmenopausal
4. Nonsterile male subjects and their female partners should agree to use an effective method of contraception through at least 12 months after CTX310 infusion
5. Adequate renal, liver and cardiac function
6. Willing to participate in a long-term follow-up study after completion of this study

Exclusion Criteria

1. No participants with Familial Chylomicronemia Syndrome (FCS)
2. Evidence of liver disease
3. History of alcohol or drug abuse
4. History of a significant coagulation disorder
5. Uncontrolled or untreated thyroid disease
6. Prior treatment with gene therapy/editing product
7. Active HIV, hepatitis B virus or hepatitis C virus infection
8. Any prior or current malignancy or myeloproliferative disorder or a significant immunodeficiency disorder

Study & Design

• Study Type: Interventional
• Study Design: Not specified