A Phase 2 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of ARO-APOC3 in Adults with Dyslipidemia
- Conditions
- Dyslipidemiaseverely high hypertriglyceridemia10013317
- Registration Number
- NL-OMON53567
- Lead Sponsor
- Arrowhead Pharmaceuticals, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 7
1. Adults >=18 years of age who are nonpregnant, nonlactating, and do not plan
to become pregnant during the study
2. Able and willing to provide written informed consent prior to the
performance of any study specific procedures
3. Completed the 48-week study treatment period in the parent study
1. Subject was permanently discontinued from ARO-APOC3 in the parent study due
to elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
2. Any new condition or worsening of existing condition (eg, renal,
hematologic, gastrointestinal, endocrine, cardiovascular, pulmonary,
immunologic, psychiatric) or any other situation that, in the Investigator*s
judgment, would make the subject unsuitable for enrollment, could interfere
with the subject participating in or completing the study, would make it
difficult to comply with protocol requirements, or put the subject at
additional safety risk
3. Unwilling to limit alcohol consumption to within moderate limits for the
duration of the study, as follows: not more than 14 units per week (1 unit
approximately corresponds to 80 mL of wine, 200 mL of beer, or 25 mL of 40%
alcohol)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method