TrialExtension Study Assessing Long Term Safety and Efficacy of IONIS-TTR Rx in Familial Amyloid Polyneuropathy (FAP)
Trial details
- Registry ID
- NCT02175004
- Phase
- Phase 3
IONS
Ionis Pharmaceuticals, Inc.
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31Trials in this database
24Recorded changes · last 12 months
Partial coverageOnly the trials and history collected so far
Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.
Completion dates · Pro
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Pro summarizes how far estimated completion dates moved later and counts trials with edits to their main study measures, using the history available here. View Pro features
Included trials
Check company identity sourceGOLDEN STUDY: A Study to Assess Safety and Efficacy of Multiple Doses of IONIS-FB-LRx in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)
Trial details
- Registry ID
- NCT03815825
- Phase
- Phase 2
A Study to Evaluate the Effectiveness and Safety of IONIS-FB-LRx, an Antisense Inhibitor of Complement Factor B, in Adult Participants With Primary IgA Nephropathy
Trial details
- Registry ID
- NCT04014335
- Phase
- Phase 2
Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sapablursen (Formerly ISIS 702843, IONIS-TMPRSS6-LRx)
Trial details
- Registry ID
- NCT04059406
- Phase
- Phase 2
CARDIO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
Trial details
- Registry ID
- NCT04136171
- Phase
- Phase 3
NEURO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
Trial details
- Registry ID
- NCT04136184
- Phase
- Phase 3
An Extension Study of Donidalorsen (IONIS-PKK-LRx) in Participants With Hereditary Angioedema
Trial details
- Registry ID
- NCT04307381
- Phase
- Phase 2
A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly
Trial details
- Registry ID
- NCT04522180
- Phase
- Phase 2
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) Administered to Patients With Familial Chylomicronemia Syndrome (FCS)
Trial details
- Registry ID
- NCT04568434
- Phase
- Phase 3
A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx in Hypertensive Participants With Uncontrolled Blood Pressure
Trial details
- Registry ID
- NCT04714320
- Phase
- Phase 2
FUSION: A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in Amyotrophic Lateral Sclerosis Participants With Fused in Sarcoma Mutations (FUS-ALS)
Trial details
- Registry ID
- NCT04768972
- Phase
- Phase 3
A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx in Participants With Chronic Heart Failure With Reduced Ejection Fraction
Trial details
- Registry ID
- NCT04836182
- Phase
- Phase 2
A Study to Evaluate the Safety and Efficacy of Zilganersen (ION373) in Patients With Alexander Disease (AxD)
Trial details
- Registry ID
- NCT04849741
- Phase
- Phase 3
A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of ION224
Trial details
- Registry ID
- NCT04932512
- Phase
- Phase 2
A Study to Assess the Long-Term Safety and Efficacy of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Patients With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
Trial details
- Registry ID
- NCT05071300
- Phase
- Phase 3
A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia
Trial details
- Registry ID
- NCT05079919
- Phase
- Phase 3
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS)
Trial details
- Registry ID
- NCT05130450
- Phase
- Phase 3
OASIS-HAE: A Study to Evaluate the Safety and Efficacy of Donidalorsen (ISIS 721744 or IONIS-PKK-LRx) in Participants With Hereditary Angioedema (HAE)
Trial details
- Registry ID
- NCT05139810
- Phase
- Phase 3
A Study to Evaluate Sapablursen (Formerly ISIS 702843, IONIS-TMPRSS6-LRx) in Patients With Polycythemia Vera
Trial details
- Registry ID
- NCT05143957
- Phase
- Phase 2
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRX) Administered to Adults With Familial Chylomicronemia Syndrome (FCS) Previously Treated With Volanesorsen
Trial details
- Registry ID
- NCT05185843
- Phase
- Phase 3
A Study to Assess the Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of ION904 in Participants With Uncontrolled Hypertension
Trial details
- Registry ID
- NCT05314439
- Phase
- Phase 2
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia
Trial details
- Registry ID
- NCT05355402
- Phase
- Phase 2
A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)
Trial details
- Registry ID
- NCT05392114
- Phase
- Phase 3
A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia
Trial details
- Registry ID
- NCT05552326
- Phase
- Phase 3
A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia
Trial details
- Registry ID
- NCT05610280
- Phase
- Phase 3
An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
Trial details
- Registry ID
- NCT05667493
- Phase
- Phase 3
CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)
Trial details
- Registry ID
- NCT05681351
- Phase
- Phase 3
REVEAL: A Phase 3 Study of Obudanersen (ION582) in Angelman Syndrome
Trial details
- Registry ID
- NCT06914609
- Phase
- Phase 3
Donidalorsen Treatment in Children With Hereditary Angioedema
Trial details
- Registry ID
- NCT07298447
- Phase
- Phase 3
A Study to Assess the Safety, Tolerability and Efficacy of ION775
Trial details
- Registry ID
- NCT07604974
- Phase
- Phase 2
CHAMPION: A Study to Evaluate the Efficacy and Safety of Obudanersen (ION582) in Children and Adults With Angelman Syndrome (AS)
Trial details
- Registry ID
- NCT07782827
- Phase
- Phase 3
Latest recorded trial changes
CARDIO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
NCT04136171 · Ionis Pharmaceuticals, Inc.
Completion date type changed
− Before
Estimated
+ After
Actual
Primary completion date changed
− Before
Apr 2026
+ After
25 Mar 2026
Recruitment status changed
− Before
Active not recruiting
+ After
Completed
FUSION: A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in Amyotrophic Lateral Sclerosis Participants With Fused in Sarcoma Mutations (FUS-ALS)
NCT04768972 · Ionis Pharmaceuticals, Inc.
Completion date type changed
− Before
Estimated
+ After
Actual
Primary completion date changed
− Before
Jun 2026
+ After
17 Jun 2026
A Study to Evaluate Sapablursen (Formerly ISIS 702843, IONIS-TMPRSS6-LRx) in Patients With Polycythemia Vera
NCT05143957 · Ionis Pharmaceuticals, Inc.
Recruitment status changed
− Before
Active not recruiting
+ After
Completed
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia
NCT05355402 · Ionis Pharmaceuticals, Inc.
Primary completion date changed
− Before
17 Jan 2023
+ After
22 Mar 2023
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia
NCT05355402 · Ionis Pharmaceuticals, Inc.
Main study measure wording changed
Text changed; whether the study measures changed has not been verified. Saved text may be shortened.
Compare wording
− Before
Measure: Percent Change From Baseline at Month 6 (average of Weeks 25 and 27) in Fasting Triglycerides (TG)
+ After
Measure: Percent Change From Baseline in Fasting TG at Month 6
Primary completion date changed
− Before
22 Mar 2023
+ After
17 Jan 2023
Donidalorsen Treatment in Children With Hereditary Angioedema
NCT07298447 · Ionis Pharmaceuticals, Inc.
Recruitment status changed
− Before
Not yet recruiting
+ After
Recruiting
An Extension Study of Donidalorsen (IONIS-PKK-LRx) in Participants With Hereditary Angioedema
NCT04307381 · Ionis Pharmaceuticals, Inc.
Main study measure wording changed
Text changed; whether the study measures changed has not been verified. Saved text may be shortened.
Compare wording
− Before
Measure: Percentage of Participants with at Least One Treatment-emergent Adverse Event (TEAE), Graded by Severity
+ After
Measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Measure: Percentage of Participants With Clinically Meaningful Changes in Clinical Laboratory Assessments Measure: Percentage of Participants With Clinically Meaningful Changes in Vital Signs Measure: Percentage of Participants With Clinically Meaningful Changes in Electrocardiograms (ECGs) Parameters Measure: Percentage of Participants Who Received At Least One Concomitant Medication
REVEAL: A Phase 3 Study of Obudanersen (ION582) in Angelman Syndrome
NCT06914609 · Ionis Pharmaceuticals, Inc.
Main study measure wording changed
Text changed; whether the study measures changed has not been verified. Saved text may be shortened.
Compare wording
− Before
Measure: Change in Performance on the Expressive Communication Subdomain Raw Score of the Bayley Scales for Infant and Toddler Development-4 (Bayley-4) in Cohort 1
+ After
Measure: Change in Performance on the Expressive Communication Subdomain Raw Score of the Bayley Scales for Infant and Toddler Development-4 (Bayley-4) Without Caregiver Input in Cohort 1
Planned enrollment decreased by 52 participants
− Before
210 participants (planned)
+ After
158 participants (planned)
CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)
NCT05681351 · Ionis Pharmaceuticals, Inc.
Participant count type changed
− Before
Estimated
+ After
Actual
Enrollment · participant count changed
− Before
800 participants (planned)
+ After
885 participants (actual)
Recruitment status changed
− Before
Recruiting
+ After
Active not recruiting
A Study to Evaluate the Safety and Efficacy of Zilganersen (ION373) in Patients With Alexander Disease (AxD)
NCT04849741 · Ionis Pharmaceuticals, Inc.
Completion date type changed
− Before
Estimated
+ After
Actual
Primary completion date changed
− Before
Sep 2025
+ After
22 Aug 2025
A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia
NCT05079919 · Ionis Pharmaceuticals, Inc.
Completion date type changed
− Before
Estimated
+ After
Actual
Primary completion date changed
− Before
Apr 2025
+ After
22 Oct 2024
Recruitment status changed
− Before
Active not recruiting
+ After
Completed
A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia
NCT05552326 · Ionis Pharmaceuticals, Inc.
Completion date type changed
− Before
Estimated
+ After
Actual
Primary completion date changed
− Before
Jun 2025
+ After
17 Dec 2024
Recruitment status changed
− Before
Active not recruiting
+ After
Completed