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NCT03400098
ATTR Expanded Access Program (EAP) by Ionis
trial testing Inotersen in Amyloidosis, Hereditary. Approved for marketing.
Quick facts
| Lead sponsor | Ionis Pharmaceuticals, Inc. |
|---|---|
| Status | APPROVED FOR MARKETING |
| Study type | EXPANDED_ACCESS |
Drugs / interventions tested
- Inotersen — full drug profile →
Conditions studied
- Amyloidosis, Hereditary — all drugs for Amyloidosis, Hereditary →
Sponsor
Ionis Pharmaceuticals, Inc. — full company profile →
Who can join
18 and older, any sex, with Amyloidosis, Hereditary. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this program is to provide expanded access to Inotersen for up to 100 Patients with Hereditary Transthyretin Amyloidosis (hTTR).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03400098
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Inotersen
Trials testing the same drug.
- NCT04136184 — NEURO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LR · Phase 3 · completed
- NCT03702829 — 24 Month Open Label Study of the Tolerability and Efficacy of Inotersen in TTR Amyloid Cardiomyopathy Patients · Phase 2 · terminated
- NCT02175004 — Extension Study Assessing Long Term Safety and Efficacy of IONIS-TTR Rx in Familial Amyloid Polyneuropathy (FAP) · Phase 3 · completed
- NCT01737398 — Efficacy and Safety of Inotersen in Familial Amyloid Polyneuropathy · Phase 2, PHASE3 · completed
Other recruiting trials for Amyloidosis, Hereditary
Currently open trials in the same condition.
- NCT07314268 — ATTR Amyloid Cardiomyopathy: Characterization of Extracellular Vesicles as Potential Disease Stratifiers and Prognostic · recruiting
- NCT05489549 — Subclinical Transthyretin Cardiac Amyloidosis in V122I TTR Carriers · recruiting
Other Ionis Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT06673069 — Hero: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) and Pharmacodynamics (PD) of ION269 in Par · Phase 1 · terminated
- NCT06014541 — Observational Study to Characterize Biomarkers and Disease Progression in Participants With Methyl CpG Binding Protein 2 · terminated
- NCT05610280 — A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, · Phase 3 · completed
- NCT05579860 — A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healt · Phase 1 · completed
- NCT05552326 — A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03400098 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ionis Pharmaceuticals, Inc.
- Last refreshed: 5 August 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03400098.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing