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Clinical trials
catalyst calendar across sponsors →Studies where SRPT is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
49 interventional · 3 observational · 16 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| A Long-term Observational Study Evaluating Eteplirsen, Golodirsen, or Casimersen in Routine Clinical PracticeNCT06606340observationalLoss of Ambulation (LOA) | — | Enrolling by invitation | Drug: Eteplirsen, Golodirsen, Casimersen | Duchenne Muscular Dystrophy | 300 | 2033-12-31 | in 2,690 d | 2025-09-10 |
| A Long-term Follow-up Study of Participants Who Received Delandistrogene Moxeparvovec (SRP-9001) in a Previous Clinical StudyNCT05967351Number of Participants with a Treatment-emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI)Open-label · Other | Phase 3 | Enrolling by invitation | Genetic: delandistrogene moxeparvovec | Duchenne Muscular Dystrophy | 400 | 2033-10-31 | in 2,629 d | 2026-02-06 |
| A Study of the Natural History of Participants With LGMD2E/R4, LGMD2D/R3, LGMD2C/R5, and LGMD2A/R1 ≥ 4 Years of Age, Who Are Managed in Routine Clinical PracticeNCT04475926observationalNSAD Total Score | — | Active, not recruiting | — | Limb-girdle Muscular Dystrophy | 205 | 2030-09-05 | in 1,477 d | 2025-11-06 |
| An Observational Study Comparing Delandistrogene Moxeparvovec (ELEVIDYS) With Standard of Care in Participants With Duchenne Muscular DystrophyNCT06270719observationalMean Change From Baseline in Time to Walk/Run 10 Meters (10MWR) (Calculated Velocity) at Month 12 | — | Enrolling by invitation | Genetic: Delandistrogene Moxeparvovec · Drug: Standard of Care | Duchenne Muscular Dystrophy | 500 | 2029-12-31 | in 1,229 d | 2026-05-04 |
| Study of SRP-1001 in Adult and Adolescent Participants With Facioscapulohumeral Muscular Dystrophy Type 1NCT06131983Number of Participants With Treatment-Emergent Adverse Events Over Time Through End of StudyRandomized · Quadruple-masked · Treatment | Phase 1/2 | Recruiting | Drug: SRP-1001 for Injection, Placebo | Muscular Dystrophy, Facioscapulohumeral | 60 | 2028-12-31 | in 864 d | 2026-08-11 |
| A Gene Transfer Single Dose Study to Evaluate the Safety, Tolerability and Efficacy of SRP-9003 in Non-Ambulatory and Ambulatory Participants With Limb Girdle Muscular Dystrophy, Type 2E/R4 (Beta-Sarcoglycan [β-SG] Deficiency)NCT05876780Number of Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)Open-label · Treatment | Phase 1 | Active, not recruiting | Genetic: SRP-9003 | Limb Girdle Muscular Dystrophy | 6 | 2028-08-28 | in 739 d | 2026-02-19 |
| A Gene Transfer Therapy Study to Evaluate the Safety of and Expression From Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD) - Non-Ambulatory CohortNCT04626674Part 1 (Cohorts 1 to 5): Change from Baseline in Quantity of Delandistrogene Moxeparvovec Dystrophin Expression at Week 12, as Measured by Western BlotOpen-label · Treatment | Phase 1 | Recruiting | Genetic: delandistrogene moxeparvovec | Duchenne Muscular Dystrophy | 83 | 2027-12-31 | in 498 d | 2026-06-24 |
| A First-in-human Study of the Effects of SRP-1005 in Participants With Huntington's DiseaseNCT07536061Number of Participants with a Treatment-emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI)Randomized · Triple-masked · Treatment | Phase 1 | Recruiting | Drug: SRP-1005, Placebo | Huntington's Disease | 32 | 2027-11-30 | in 467 d | 2026-06-04 |
| A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Non-Ambulatory and Ambulatory Participants With Duchenne Muscular Dystrophy (DMD)NCT05881408Part 1: Change From Baseline in the Total Score of Performance of Upper Limb (PUL) (Version 2.0) at Week 72Randomized · Quadruple-masked · Treatment | Phase 3 | Active, not recruiting | Genetic: delandistrogene moxeparvovec, placebo | Duchenne Muscular Dystrophy | 148 | 2027-05-31 | in 284 d | 2026-05-22 |
| Study to Evaluate the Safety and Effectiveness of ELEVIDYS in Participants With Duchenne Muscular Dystrophy Treated in a Post-Marketing SettingNCT07542314Cohort 1: Number of Participants with ALINon-randomized · Open-label · Treatment | Phase 4 | Not yet recruiting | Drug: ELEVIDYS, Sirolimus, Glucocorticoids, Antibiotics | Duchenne Muscular Dystrophy | 20 | 2027-03-31 | in 223 d | 2026-05-26 |
| Study of SRP-1003 in Participants With Type 1 Myotonic DystrophyNCT06138743Number of Participants with Treatment-emergent Adverse Events Over Time Through End of Study (EOS)Randomized · Quadruple-masked · Treatment | Phase 1/2 | Recruiting | Drug: SRP-1003 IV Infusion, Placebo IV Infusion, SRP-1003 SC Injection, Placebo SC Injection | Myotonic Dystrophy 1 | 78 | 2026-12-31 | in 133 d | 2026-08-11 |
| A Study to Compare Safety and Efficacy of High Doses of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) (MIS51ON)NCT03992430Part 1: Incidence of Adverse Events (AEs)Randomized · Quadruple-masked · Treatment | Phase 3 | Active, not recruiting | Drug: Eteplirsen | Muscular Dystrophy, Duchenne | 160 | 2026-10-31 | in 72 d | 2026-02-27 |
| A Trial to Learn More About an Experimental Gene Therapy Called Bidridistrogene Xeboparvovec (SRP-9003) as a Possible Treatment for Limb Girdle Muscular Dystrophy 2E/R4NCT06246513Cohort 1: Change from Baseline in β-SG Expression at Day 60 Post-dose as Measured by Immunofluorescence (IF) Percent β-SG Positive FibersOpen-label · Treatment | Phase 3 | Active, not recruiting | Biological: SRP-9003 · Drug: Glucocorticoid | Limb-girdle Muscular Dystrophy | 17 | 2025-03-04actual | — | 2026-03-02 |
| A Study of SRP-9005 in Limb Girdle Muscular Dystrophy Type 2C/R5 Pediatric and Adult ParticipantsNCT06952686Part A : Number of Participants with Treatment-emergent Adverse Events (TEAEs)Open-label · Treatment | Phase 3 | Withdrawnsponsor's stated reason: Study was Withdrawn per Sponsor decision. | Biological: SRP-9005 · Drug: Corticosteroid | Muscular Dystrophies, Limb-Girdle | 0 | 2030-11-30 | in 1,563 d | 2025-08-06 |
| A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) Following Imlifidase Infusion in Participants With Duchenne Muscular Dystrophy (DMD) Determined to Have Pre-existing Antibodies to Recombinant Adeno-Associated Virus Serotype (rAAVrh74)NCT06241950Change From Baseline in Quantity of Delandistrogene Moxeparvovec Dystrophin Protein Expression as Measured by Western Blot Adjusted by Muscle ContentOpen-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Study is being terminated due to a business decision. | Genetic: delandistrogene moxeparvovec · Biological: imlifidase | Duchenne Muscular Dystrophy | 5 | 2025-10-10actual | — | 2025-11-20 |
| A Gene Transfer Therapy to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) Following Therapeutic Plasma Exchange (Plasmapheresis) in Participants With Duchenne Muscular Dystrophy (DMD) and Pre-existing Antibodies to AAVrh74NCT06597656Change From Baseline in Quantity of Delandistrogene Moxeparvovec Dystrophin Expression Adjusted by Muscle Content Biopsied Muscle as Measured by Western BlotOpen-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Study is being terminated due to a business decision. | Genetic: delandistrogene moxeparvovec · Procedure: Plasmapheresis | Duchenne Muscular Dystrophy | 3 | 2025-08-05actual | — | 2025-09-04 |
| Study to Evaluate the Safety, Tolerability, and Efficacy of SRP-9004 Administered by Systemic Infusion in Limb Girdle Muscular Dystrophy Type 2D/R3 Participants in the United StatesNCT06747273Number of Participants with Treatment-emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESI) and Treatment-emergent Serious Adverse Events (SAEs)Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Study is being terminated due to a business decision. | Drug: SRP-9004 | Limb Girdle Muscular Dystrophy, Limb Girdle Muscular Dystrophy Type 2D/R3 | 4 | 2025-06-18actual | — | 2025-09-04 |
| A Gene Transfer Study to Evaluate the Safety, Tolerability and Efficacy of SRP-6004 in Ambulatory Participants With Limb Girdle Muscular Dystrophy, Type 2B/R2 (LGMD2B/R2, Dysferlin [DYSF] Related)NCT05906251Number of Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Study is being terminated due to a business decision. | Genetic: SRP-6004 | Limb Girdle Muscular Dystrophy | 2 | 2025-06-13actual | — | 2025-09-04 |
| Gene Delivery Clinical Trial of SRP-9003 (Bidridistrogene Xeboparvovec) for Participants With Limb-Girdle Muscular Dystrophy, Type 2E (LGMD2E) (Beta-Sarcoglycan Deficiency)NCT03652259Number of Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)Non-randomized · Open-label · Treatment | Phase 1/2 | Terminatedsponsor's stated reason: Study is being terminated due to a business decision. | Genetic: SRP-9003 | Limb-Girdle Muscular Dystrophy, Type 2E | 6 | 2025-01-14actual | — | 2026-01-20 |
| Study of SRP-4045 (Casimersen) and SRP-4053 (Golodirsen) in Participants With Duchenne Muscular Dystrophy (DMD)NCT02500381Change From Baseline in the 4-Step Ascend Velocity at Week 96Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: SRP-4045, SRP-4053, Placebo | Duchenne Muscular Dystrophy | 228 | 2024-11-12actual | — | 2025-11-18 |
| Two-Part Study for Dose Determination of Vesleteplirsen (SRP-5051) (Part A), Then Dose Expansion (Part B) in Participants With Duchenne Muscular Dystrophy Amenable to Exon 51-Skipping TreatmentNCT04004065Part A: Incidence of Adverse Events (AEs)Randomized · Open-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: The study was terminated following review of safety data. | Drug: Vesleteplirsen | Duchenne Muscular Dystrophy | 62 | 2023-10-30actual | — | 2025-03-10 |
| A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD)NCT05096221results2024-12-10Part 1: Change From Baseline in North Star Ambulatory Assessment (NSAA) Total Score at Week 52Randomized · Quadruple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Genetic: delandistrogene moxeparvovec, placebo | Duchenne Muscular Dystrophy | 126 | 2023-10-04actual | — | 2025-07-08 |
| An Extension Study to Evaluate Casimersen or Golodirsen in Patients With Duchenne Muscular DystrophyNCT03532542results2024-09-19Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)Non-randomized · Open-label · TreatmentStudy Protocol ↗ | Phase 3 | Terminatedsponsor's stated reason: The trial was stopped to reduce the clinical trial burden on participants while ensuring continued treatment via a post-trial access program with commercially available casimersen and golodirsen. Study was not terminated due to safety concerns. | Drug: Casimersen, Golodirsen | Duchenne Muscular Dystrophy | 171 | 2023-07-26actual | — | 2024-09-19 |
| A Gene Transfer Therapy Study to Evaluate the Safety of Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD)NCT03375164results2024-05-23Number of Participants With Adverse Events (AEs)Non-randomized · Open-label · TreatmentStudy Protocol ↗ | Phase 1/2 | Completed | Genetic: delandistrogene moxeparvovec | Duchenne Muscular Dystrophy | 4 | 2023-04-25actual | — | 2024-11-14 |
| A Study to Evaluate Safety, Tolerability, and Efficacy of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) Who Have Completed Study 4658-102 (NCT03218995)NCT03985878results2023-08-18Number of Participants Experiencing Adverse Events (AEs)Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Participants were either transitioned to a post-trial access program or another Sarepta study, or they declined further treatment. There are no safety concerns with Eteplirsen. | Drug: Eteplirsen | Duchenne Muscular Dystrophy | 15 | 2022-08-31actual | — | 2023-08-18 |
| An Open-Label Extension Study for Patients With Duchenne Muscular Dystrophy Who Participated in Studies of SRP-5051 (Vesleteplirsen)NCT03675126results2024-09-19Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)Open-label · TreatmentStudy Protocol ↗ | Phase 1/2 | Terminatedsponsor's stated reason: The sponsor has decided to integrate 5051-102 into 5051-201. Participants from 5051-102 will be eligible to enroll in 5051-201 Part B. | Drug: SRP-5051 | Muscular Dystrophy, Duchenne | 15 | 2021-08-25actual | — | 2024-09-19 |
| Study of Eteplirsen in Young Participants With Duchenne Muscular Dystrophy (DMD) Amenable to Exon 51 SkippingNCT03218995results2021-12-09Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation From Study DrugOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Eteplirsen | Duchenne Muscular Dystrophy | 15 | 2021-03-10actual | — | 2021-12-09 |
| A Randomized, Double-blind, Placebo-controlled Study of Delandistrogene Moxeparvovec (SRP-9001) for Duchenne Muscular Dystrophy (DMD)NCT03769116results2023-09-15Change From Baseline at Week 12 in Quantity of Delandistrogene Moxeparvovec Dystrophin Protein Expression as Measured by Western Blot Adjusted by Muscle ContentRandomized · Quadruple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Genetic: delandistrogene moxeparvovec, placebo | Muscular Dystrophy, Duchenne | 41 | 2020-12-08actual | — | 2024-11-14 |
| A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Dose of SRP-5051 (Vesleteplirsen) in Patients With Duchenne Muscular Dystrophy (DMD)NCT03375255Number of Participants with Adverse Events (AEs)Open-label · Treatment | Phase 1 | Completed | Drug: SRP-5051 | Muscular Dystrophy, Duchenne | 15 | 2019-08-19actual | — | 2022-07-06 |
| rAAVrh74.MHCK7.DYSF.DV for Treatment of DysferlinopathiesNCT02710500Determination of safety based on the development of unacceptable toxicityNon-randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: rAAVrh74.MHCK7.DYSF.DV | Dysferlinopathy | 2 | Jul 2019actual | — | 2021-05-13 |
| Study of Eteplirsen in DMD PatientsNCT02255552results2020-07-01Change From Baseline in the 6 Minute Walk Test (6MWT) Distance at Week 96Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: eteplirsen | Duchenne Muscular Dystrophy (DMD) | 109 | 2019-06-14actual | — | 2021-01-25 |
| Phase I/II Study of SRP-4053 in DMD PatientsNCT02310906results2020-10-19Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to DiscontinuationRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: Placebo, SRP-4053 | Duchenne Muscular Dystrophy | 39 | 2019-03-25actual | — | 2020-10-19 |
| A Gene Transfer Therapy Study to Evaluate the Safety of SRP-9004 (Patidistrogene Bexoparvovec) in Participants With Limb-Girdle Muscular Dystrophy, Type 2D (LGMD2D)NCT01976091results2022-04-01Number of Participants With Adverse Events (AEs).Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Genetic: SRP-9004 | Limb-Girdle Muscular Dystrophy, Type 2D | 6 | 2019-03-14actual | — | 2023-06-15 |
| Safety Study of Eteplirsen to Treat Early Stage Duchenne Muscular DystrophyNCT02420379results2020-07-22Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to DiscontinuationNon-randomized · Open-label · TreatmentStatistical Analysis Plan ↗ · Study Protocol ↗ | Phase 2 | Completed | Drug: eteplirsen | Duchenne Muscular Dystrophy (DMD) | 33 | 2018-12-17actual | — | 2021-01-25 |
| Dose-Titration and Open-label Extension Study of SRP-4045 in Advanced Stage Duchenne Muscular Dystrophy (DMD) PatientsNCT02530905results2021-05-17Number of Participants With Treatment Emergent Adverse Events (TEAEs)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: SRP-4045, Placebo | Duchenne Muscular Dystrophy | 12 | 2018-10-03actual | — | 2021-05-17 |
| Safety Study of Eteplirsen to Treat Advanced Stage Duchenne Muscular DystrophyNCT02286947results2019-02-20Number of Participants With Treatment Emergent Adverse EventsOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Eteplirsen | Muscular Dystrophy, Duchenne | 24 | 2017-04-21actual | — | 2020-03-30 |
| Efficacy, Safety, and Tolerability Rollover Study of Eteplirsen in Subjects With Duchenne Muscular DystrophyNCT01540409results2019-07-10Change From Baseline in the 6 Minute Walk Test (6MWT) at Week 240Open-label · Treatment | Phase 2 | Completed | Drug: AVI-4658 (Eteplirsen) | Duchenne Muscular Dystrophy (DMD) | 12 | 2016-04-15actual | — | 2020-03-30 |
| A Study to Assess the Safety, Tolerability and Pharmacokinetics of AVI-7288 in Healthy Adult VolunteersNCT01566877The outcome measure is safety, as assessed through adverse event evaluation and serial clinical assessments.Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: AVI-7288 · Other: Placebo | Marburg Hemorrhagic Fever | 40 | Jan 2014actual | — | 2014-05-07 |
| A Study to Assess the Safety, Tolerability and Pharmacokinetics of AVI-7537 in Healthy Adult VolunteersNCT01593072The outcome measures are Serial PK Day 1 over 24 hrs(pre-dose,10 min post,30 min post, 1hr 1.5,2,4,6, 8, 12,16,24,28,32,36, and 48 hrs post-dose), daily through level and on Day 14 (last day of dosing) serial PK until 48 hrs post last dose.Randomized · Quadruple-masked · Treatment | Phase 1 | Withdrawnsponsor's stated reason: Terminated for convenience of the Government due to funding constraits | Drug: AVI-7537 · Other: Normal Saline Solution (NSS) | Ebola Hemorrhagic Fever | 0 | Jan 2013 | — | 2013-01-24 |
| Efficacy Study of AVI-4658 to Induce Dystrophin Expression in Selected Duchenne Muscular Dystrophy PatientsNCT01396239results2015-11-09Change in the Number (%) of Dystrophin Positive FibersRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: AVI-4658 (Eteplirsen) · Other: Placebo | Duchenne Muscular Dystrophy | 12 | Feb 2012actual | — | 2020-03-30 |
| Safety Study of Single Administration Post-exposure Prophylaxis Treatment for Marburg VirusNCT01353040Number of subjects experiencing adverse eventsRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: AVI-6003, Placebo | Marburg Hemorrhagic Fever | 30 | Dec 2011actual | — | 2012-05-07 |
| Safety Study of Single Administration Post-Exposure Prophylaxis Treatment for Ebola VirusNCT01353027Number of participants with adverse eventsRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: Placebo, AVI-6002 | Ebola Hemorrhagic Fever | 30 | Nov 2011actual | — | 2012-03-28 |
| Safety Study of Single Administration Intravenous Treatment for InfluenzaNCT01375985Number of subjects experiencing adverse eventsRandomized · Quadruple-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: The study was halted after enrollment of the first cohort because of lack of funding | Drug: AVI-7100, Placebo | Influenza | 8 | Aug 2011actual | — | 2013-06-11 |
| Dose-Ranging Study of AVI-4658 to Induce Dystrophin Expression in Selected Duchenne Muscular Dystrophy (DMD) PatientsNCT00844597results2015-10-06Safety and TolerabilityNon-randomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: AVI-4658 for Injection | Duchenne Muscular Dystrophy | 19 | Jun 2010actual | — | 2015-10-06 |
| Safety and Efficacy Study of AVI-5126 When Used on Vein Grafts Before Use in Heart by-Pass Graft Surgery (CABG)NCT00451256to evaluate the safety of 10µM AVI-5126 immersion of excised saphenous vein segments prior to CABG compared to immersion in the Placebo at Day 14 and Months 1, 3, 6, 9, and 12 after CABG.Randomized · Double-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Protocol-defined outcome in terms of efficacy would not be achieved. | Drug: AVI-5126 | Cardiovascular Disease, Coronary Artery Bypass | 600 | Nov 2007actual | — | 2009-07-08 |
| Pharmacokinetic Study in Cerebral Spinal Fluid After a Single Dose of AVI-4020NCT00387283To determine if the study drug penetrates the blood brain barrier following a single dose of AVI-4020, and if it does, the associated CSF, plasma and urine pharmacokineticsNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: AVI-4020 Injection | West Nile Virus | 14 | Dec 2006actual | — | 2009-07-08 |
| Study of AVI-4065 in Healthy Volunteers and Chronic Active HCV PatientsNCT00229749Safety and tolerabilityNon-randomized · Open-label · Treatment | Phase 1/2 | Terminatedsponsor's stated reason: Limited viral load reduction in HCV subjects | Drug: AVI-4065 Injection | Hepatitis C | 80 | Oct 2006actual | — | 2008-04-10 |
| Pharmacokinetic Study of a Single Dose of AVI-4065 in Cerebral Spinal FluidNCT00381433To determine if the study drug penetrates the blood brain barrier following a single intravenous dose, and if so, the associated CSF, plasma and urine pharmacokinetics.Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: AVI-4065 Injection | Encephalitis | 12 | Oct 2006actual | — | 2009-07-08 |
| Pharmacokinetic Study of a Single Dose of AVI-4126 (RESTEN-NG®) in Cerebral Spinal FluidNCT00343148To determine if the study drug penetrates the blood brain barrier following a single intravenous dose, and if so, the associated CSF, plasma and urine pharmacokinetics.Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: AVI-4126 Injection (RESTEN-NG®) | Neoplasms | 6 | Jun 2006actual | — | 2009-07-08 |
| An Exploratory Study of AVI-4020 in Patients With Possible Acute Neuroinvasive West Nile Virus (WNV) DiseaseNCT00091845Safety and tolerability assessments will be based on evaluations of treatment emergent adverse events (TEAE), serious adverse events (SAE), serial clinical examinations, and serial conventional laboratory tests.Non-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Due to limited pool of eligble WNV patients | Drug: AVI-4020 Injection | West Nile Fever | 50 | — | — | 2009-07-08 |
| A Phase 1b Study Evaluating RESTEN-MP in Subjects With Focal de Novo StenosisNCT00244647Safety of a single IV slow-push injection of RESTEN-MP administered at the time of Taxus Express™ placement and over a six month surveillance period.Randomized · Single-masked · Treatment | Phase 1 | Terminated | Drug: RESTEN-MP | Coronary Artery Disease, Coronary Stent Restenosis | 40 | — | — | 2008-04-10 |
| Safety and Efficacy of RESTEN-MP When Used in Conjunction With a Bare Metal Stent in Coronary ArteriesNCT00248066Evaluate the potential efficacy of RESTEN-MP given intravenously upon confirmation of stent implantation and again at 24 hours post-stent implantationNon-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: RESTEN-MP | Coronary Artery Disease, Coronary Restenosis | 50 | — | — | 2007-02-08 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19