16 completed, 2 terminated, 1 active not recruiting, 1 not yet recruiting. 7 Phase 1, 7 Phase 2, 4 Phase 3, 1 Not applicable, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 7 | Completed 7 |
| Phase 2 | 7 | Completed 5, Terminated 1, Withdrawn 1 |
| Phase 3 | 4 | Completed 3, Terminated 1 |
| Not applicable | 1 | Recruiting 1 |
| Phase 4 | 1 | Terminated 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| TEGSEDI Pregnancy Surveillance Program inotersen - Hereditary Transthyretin-mediated Amyloidosis With Polyneropathy, Pregnancy | Not yet recruiting | Akcea Therapeutics | 20 | 2025-12-01 | 2025-08-19 | |
| A Non-interventional Cohort Safety Study of Patients With hATTR-PN Data Collection - Hereditary Transthyretin Amyloidosis With Polyneuropthy | Active not recruiting | Akcea Therapeutics | 202 | 2021-09-21 | 2026-07-29 | |
| A Study to Characterize Adverse Events Occurring Within One Day of TEGSEDI Administration to Adult Participants With hATTR-PN TEGSEDI - Hereditary Transthyretin Amyloidosis With Polyneuropthy | Phase 4 | Terminated | Akcea Therapeutics | 8 | 2021-01-21 | 2025-04-10 |
| Prevalence and Prediction of ATTR in Ambulatory Patients With HFpEF 99mTc-pyrophosphate Scintigraphy - Transthyretin Amyloidosis, Heart Failure | Not applicable | Recruiting | Massachusetts General Hospital | 515 | 2020-10-02 | 2026-09-01 |
| InFocus France Epidemiological Study of Health Burden in Major Hypertriglyceridemia observational : questionnaries for assessment of health burden - Familial Chylomicronemia Syndrome, Multifactorial Chylomicronemia Syndrome | Completed | New French Society of Atherosclerosis | 52 | 2018-09-19 | 2020-01-10 | |
| Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Partial Lipodystrophy (FPL) AKCEA-ANGPTL3-LRx - Familial Partial Lipodystrophy | Phase 2 | Completed | Akcea Therapeutics | 4 | 2018-06-15 | 2021-02-16 |
| Study of AKCEA-ANGPTL3-LRX (ISIS 703802) in Patients With Homozygous Familial Hypercholesterolemia (HoFH) AKCEA-ANGPTL3-LRX - Homozygous Familial Hypercholesterolemia | Phase 2 | Withdrawn | Akcea Therapeutics | 2018-04-12 | 2018-12-03 | |
| Study of ISIS 681257 in Patients With Renal Impairment Compared to Healthy Patients ISIS 681257 - Renal Impairment | Phase 1 | Completed | Akcea Therapeutics | 16 | 2018-03-20 | 2019-05-22 |
| Study of ISIS 678354 (AKCEA-APOCIII-LRx) in Participants With Hypertriglyceridemia and Established Cardiovascular Disease (CVD) ISIS 678354, Placebo - Hypertriglyceridemia, Cardiovascular Diseases | Phase 2 | Completed | Akcea Therapeutics | 114 | 2018-01-30 | 2023-01-11 |
| Drug-drug Interaction Study to Evaluate the Effect of ISIS 681257 on Clopidogrel ISIS 681257, Clopidogrel - Elevated Lipoprotein(a), Cardiovascular Diseases | Phase 1 | Completed | Akcea Therapeutics | 18 | 2017-12-28 | 2018-04-05 |
| Study of ISIS 703802 in Participants With Hypertriglyceridemia, Type 2 Diabetes Mellitus, and Nonalcoholic Fatty Liver Disease Placebo, ISIS 703802 40 mg, ISIS 703802 80 mg - NAFLD, Diabetes Mellitus, Type 2 | Phase 2 | Completed | Akcea Therapeutics | 105 | 2017-12-21 | 2021-02-01 |
| Phase 2 Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Chylomicronemia Syndrome (FCS) AKCEA-ANGPTL3-LRx - Familial Chylomicronemia Syndrome, Lipoprotein Lipase Deficiency | Phase 2 | Completed | Akcea Therapeutics | 3 | 2017-12-21 | 2021-01-07 |
| Drug-drug Interaction Study to Evaluate the Effect of ISIS 681257 on Warfarin ISIS 681257, Warfarin - Elevated Lipoprotein(a), Cardiovascular Diseases | Phase 1 | Completed | Akcea Therapeutics | 18 | 2017-12-15 | 2018-04-05 |
| Phase 2 Study of ISIS 681257 (AKCEA-APO(a)-LRx) in Participants With Hyperlipoproteinemia(a) and Cardiovascular Disease ISIS 681257, Placebo - Elevated Lipoprotein(a), Cardiovascular Disease | Phase 2 | Completed | Akcea Therapeutics | 286 | 2017-03-07 | 2020-10-30 |
| A Study to Evaluate the Effect of Volanesorsen on Cardiac Repolarization Conducted in Healthy Volunteers Volanesorsen, Moxifloxacin, Placebo - Abnormalities, Cardiovascular | Phase 1 | Completed | Ionis Pharmaceuticals, Inc. | 52 | 2016-09-19 | 2022-01-28 |
| Safety, Tolerability, PK, and Pharmacodynamics(PD) of IONIS APOCIII-LRx in Healthy Volunteers With Elevated Triglycerides APOC-III-L-Rx, Placebo Comparator - Elevated Triglycerides (TG) | Phase 1 | Completed | Ionis Pharmaceuticals, Inc. | 56 | 2016-09-01 | 2018-05-22 |
| The BROADEN Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Partial Lipodystrophy volanesorsen, Placebo - Familial Partial Lipodystrophy | Phase 2 / Phase 3 | Terminated | Akcea Therapeutics | 40 | 2015-12-28 | 2021-10-18 |
| The Approach Open Label Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Chylomicronemia Syndrome Volanesorsen - Familial Chylomicronemia Syndrome, Lipoprotein Lipase Deficiency | Phase 3 | Completed | Akcea Therapeutics | 68 | 2015-12-23 | 2021-08-26 |
| Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS ANGPTL3-LRx in Healthy Volunteers With Elevated Triglycerides and Participants With Familial Hypercholesterolemia IONIS ANGPTL3-LRx, Placebo - Hypertriglyceridemia, Familial Hypercholesterolemia | Phase 1 | Completed | Ionis Pharmaceuticals, Inc. | 48 | 2015-11-30 | 2020-11-19 |
| Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS APO(a)-LRx in Healthy Volunteers With Elevated Lipoprotein(a) IONIS-APO(a)-LRx, Sterile Normal Saline (0.9% NaCl) - Elevated Lipoprotein(a) | Phase 1 | Completed | Ionis Pharmaceuticals, Inc. | 60 | 2015-04-01 | 2018-12-05 |
Showing 20 of 23. Sign in to see all of them.
Dyslipidemias (5) · Familial hyperchylomicronemia syndrome (5) · Hypertriglyceridemia (5) · Amyloidosis, Hereditary, Transthyretin-Related (4) · Cardiovascular Diseases (4) · Hyperlipidemias (4) · Lipid Metabolism Disorders (4) · Metabolic Diseases (4) · Amyloidosis (3) · Hyperlipoproteinemia Type I (3) · Hyperlipoproteinemias (3) · Genetic Diseases, Inborn (2) · Lipid Metabolism, Inborn Errors (2) · Lipodystrophy, Familial Partial (2) · Metabolism, Inborn Errors (2)
ISIS 304801 (6) · IONIS-ANGPTL3-LRx (3) · Inotersen (2) · vupanorsen (2) · AKCEA-APO(a)-LRx (1) · Apolipoprotein C-III (1) · Clopidogrel (1) · Data Collection (1) · Moxifloxacin (1) · Warfarin (1) · pelacarsen (1)
Canada (16) · United States (12) · Germany (6) · France (5) · Netherlands (5) · Brazil (3) · Italy (3) · Spain (3) · United Kingdom (3) · Israel (2) · South Africa (2) · Belgium (1) · Bulgaria (1) · Cyprus (1) · Denmark (1)
Hanna K Gaggin, MD (1) · Janice Faulknor (1) · Philippe Moulin (1)
PMID 37070852, PMID 37164837, PMID 27271183, PMID 27665230, PMID 28538111, PMID 29748148, PMID 31329855, PMID 31390500, PMID 31893580, PMID 32268367, PMID 33798466, PMID 35025993, PMID 39331470, PMID 42753678
2015 (3), 2014 (2), 2016 (1)