A Safety and Tolerability Study Evaluating CTX320 in Subjects With Elevated Lipoprotein(a) and a History of Atherosclerotic Cardiovascular Disease or Calcific Aortic Valve Stenosis.
- Conditions
- Elevated Lipoprotein(a)Calcific Aortic Valve StenosisAtherosclerotic Cardiovascular DiseaseCardiovascular - Other cardiovascular diseasesMetabolic and Endocrine - Other metabolic disorders
- Registration Number
- ACTRN12623001095651
- Lead Sponsor
- CRISPR Therapeutics AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 24
1. Subjects diagnosed with a history of stable atherosclerotic cardiovascular disease or presence of mild to moderate calcific aortic valve disease
2. Subjects on available standard of care lines of treatment
3. Elevated serum Lp(a)
4. All subjects and their partners should agree to use an effective method of contraception through at least 12 months after CTX320 infusion
1. Evidence of liver disease
2. History of alcohol or drug abuse
3. History of a significant coagulation disorder
4. Severe aortic stenosis
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
9. Women who are pregnant or breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of dose-limiting toxicities (DLTs). DLTs will be monitored with blood and urine tests, physical exam, vital sign assessments and 12 lead ECG. DLTs will be graded using CTCAE version 5.0.[ DLTs will be closely monitored post-infusion during the 30-day acute safety evaluation period and for up to 12 months post-intervention dose.]
- Secondary Outcome Measures
Name Time Method