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Antisense Oligonucleotide
Olezarsen for Chylomicronemia Syndrome (BALANCE Trial)
Phase 3
Waitlist Available
Research Sponsored by Ionis Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 6 and month 12
Awards & highlights
BALANCE Trial Summary
This trial will compare the effect of Olezarsen vs. placebo on fasting triglyceride levels.
Eligible Conditions
- Familial Chylomicronemia Syndrome
BALANCE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, month 6 and month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 6 and month 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent Change from Baseline in Fasting TG at 6 Months (average of Weeks 23, 25, and 27) compared to placebo
Secondary outcome measures
Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo
Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo in Patients with a History of Pancreatitis within 10 Years Prior to Screening
Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo, in Participants with ≥ 2 Events of Adjudicated Acute Pancreatitis in 5 Years Prior to Enrollment
+8 moreBALANCE Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: OlezarsenExperimental Treatment1 Intervention
Olezarsen will be administered once every 4 weeks by subcutaneous (SC) injection from Week 1 through Week 49.
Group II: PlaceboPlacebo Group1 Intervention
Olezarsen-matching placebo will be administered once every 4 weeks by SC injection from Week 1 through Week 49.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olezarsen
2022
Completed Phase 3
~330
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Who is running the clinical trial?
Ionis Pharmaceuticals, Inc.Lead Sponsor
146 Previous Clinical Trials
15,216 Total Patients Enrolled
Akcea TherapeuticsIndustry Sponsor
23 Previous Clinical Trials
1,971 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of pancreatitis. If you have no record of pancreatitis, you can still participate but only up to a certain limit.If you are taking drugs to lower your cholesterol levels, you can still participate in the trial as long as your dosage remains unchanged.
Research Study Groups:
This trial has the following groups:- Group 1: Olezarsen
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In how many distinct places is this clinical trial being conducted?
"To limit travel time and other related costs, please choose the 39 trial locations that are nearest to you. There are participating sites in Dallas, Houston, and Montreal, among other places."
Answered by AI
Could you please explain the possible side effects of AKCEA-APOCIII-LRx?
"Given that this is a Phase 3 clinical trial with available data supporting efficacy and safety, our team has rated AKCEA-APOCIII-LRx as a 3 on our safety scale."
Answered by AI
Are volunteers still needed for this research project?
"From the information available on clinicaltrials.gov, it seems as if this trial is no longer actively recruiting patients. This particular study was first posted on November 16th 2020 and was last updated on August 6th 2020. Although this study is no longer recruiting, there are 1436 other trials that are currently looking for participants."
Answered by AI
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