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ClinicalTrials.gov public records Last synced May 21, 2026, 7:19 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Showing 1–24 of 25 matching trials from the live ClinicalTrials.gov search.

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Filters: Condition: Factor VIII (FVIII) Gene Clear all

Active, not recruiting Phase 1 Interventional

Gene Therapy Trial for Platelet Derived Factor VIII Production in Hemophilia A

NCT03818763

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Conditions: Hemophilia A
Interventions: Auto CD34+PBSC, transduced with a lentiviral vector encoding the B domain deleted from of human coagulation factor VIII; Biological
Lead sponsor: Medical College of Wisconsin; Other
Eligibility: 18 Years and older · Male only

Enrollment: 5 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2020 – 2033
U.S. locations: 1
States / cities: Milwaukee, Wisconsin

Source: ClinicalTrials.gov public record

Updated Nov 12, 2025 · Synced May 21, 2026, 7:19 PM EDT

Completed Phase 3 Interventional Results available

Study to Evaluate the Efficacy and Safety of Valoctocogene Roxaparvovec, With Prophylactic Steroids in Hemophilia A

NCT04323098

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Conditions: Hemophilia A
Interventions: valoctocogene roxaparvovec; Biological
Lead sponsor: BioMarin Pharmaceutical; Industry
Eligibility: 18 Years and older · Male only

Enrollment: 22 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2020 – 2025
U.S. locations: 3
States / cities: Sacramento, California • St Louis, Missouri • Columbus, Ohio

Source: ClinicalTrials.gov public record

Updated Oct 7, 2025 · Synced May 21, 2026, 7:19 PM EDT

Active, not recruiting Phase 1Phase 2 Interventional

Gene Therapy for Haemophilia A.

NCT03001830

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Conditions: Hemophilia A
Interventions: AAV2/8-HLP-FVIII-V3; Biological
Lead sponsor: University College, London; Other
Eligibility: 18 Years and older · Male only

Enrollment: 14 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2017 – 2029
U.S. locations: 3
States / cities: Boise, Idaho • Lexington, Kentucky • Memphis, Tennessee

Source: ClinicalTrials.gov public record

Updated Mar 4, 2025 · Synced May 21, 2026, 7:19 PM EDT

Recruiting Phase 1Phase 2 Interventional

A Gene Therapy Study of SPK-8011QQ in Adults With Severe or Moderately Severe Hemophilia A

NCT07226206

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Conditions: Hemophilia A
Interventions: SPK-8011QQ; Drug
Lead sponsor: Hoffmann-La Roche; Industry
Eligibility: 18 Years and older · Male only

Enrollment: 5 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2026 – 2031
U.S. locations: 2
States / cities: Orange, California • Vallejo, California

Source: ClinicalTrials.gov public record

Updated Apr 26, 2026 · Synced May 21, 2026, 7:19 PM EDT

Completed Phase 2 Interventional Results available

A Study of Recombinant AAV2/6 Human Factor 8 Gene Therapy SB-525 (PF-07055480) in Subjects With Severe Hemophilia A

NCT03061201

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Conditions: Hemophilia A
Interventions: SB-525 (PF-07055480); Biological
Lead sponsor: Pfizer; Industry
Eligibility: 18 Years and older · Male only

Enrollment: 13 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2017 – 2024
U.S. locations: 22
States / cities: Little Rock, Arkansas • Duarte, California • Sacramento, California + 7 more

Source: ClinicalTrials.gov public record

Updated Sep 29, 2025 · Synced May 21, 2026, 7:19 PM EDT

Completed Phase 3 Interventional Results available

A Study to Evaluate Prospective Efficacy and Safety Data of Current FIX Prophylaxis Replacement Therapy in Adult Hemophilia B Subjects (FIX:C≤2%) or Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Subjects (FVIII:C≤1%)

NCT03587116

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Conditions: Hemophilia B, Hemophilia A
Interventions: Standard of Care FIX Replacement therapy, Standard of Care FVIII Replacement therapy; Drug
Lead sponsor: Pfizer; Industry
Eligibility: 18 Years to 64 Years · Male only

Enrollment: 212 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2018 – 2024
U.S. locations: 13
States / cities: Palo Alto, California • San Francisco, California • Stanford, California + 7 more

Source: ClinicalTrials.gov public record

Updated Nov 5, 2025 · Synced May 21, 2026, 7:19 PM EDT

Completed Phase 3 Interventional Results available

Single-Arm Study To Evaluate The Efficacy and Safety of Valoctocogene Roxaparvovec in Hemophilia A Patients (BMN 270-301)

NCT03370913

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Conditions: Hemophilia A
Interventions: valoctocogene roxaparvovec; Biological
Lead sponsor: BioMarin Pharmaceutical; Industry
Eligibility: 18 Years and older · Male only

Enrollment: 144 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2017 – 2024
U.S. locations: 15
States / cities: Los Angeles, California • Sacramento, California • San Diego, California + 12 more

Source: ClinicalTrials.gov public record

Updated Mar 24, 2025 · Synced May 21, 2026, 7:19 PM EDT

Terminated Phase 1Phase 2 Interventional Results available

Safety & Efficacy of Encapsulated Allogeneic FVIII Cell Therapy in Haemophilia A

NCT04541628

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Conditions: Hemophilia A
Interventions: SIG-001; Combination Product
Lead sponsor: Eli Lilly and Company; Industry
Eligibility: 18 Years and older · Male only

Enrollment: 3 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2020 – 2023
U.S. locations: 3
States / cities: Indianapolis, Indiana • Boston, Massachusetts • Seattle, Washington

Source: ClinicalTrials.gov public record

Updated Sep 3, 2024 · Synced May 21, 2026, 7:19 PM EDT

Active, not recruiting Phase 1Phase 2 Interventional

Study to Test the Safety and How Well Patients With Severe Hemophilia A Respond to Treatment With BAY 2599023 (DTX 201), a Drug Therapy That Delivers a Healthy Version of the Defective Factor VIII Gene Into the Nucleus of Liver Cells Using an Altered, Non-infectious Virus (AAV) as a "Shuttle"

NCT03588299

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Conditions: Hemophilia A
Interventions: BAY2599023 (DTX201); Drug
Lead sponsor: Bayer; Industry
Eligibility: 18 Years and older · Male only

Enrollment: 11 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2018 – 2026
U.S. locations: 3
States / cities: Little Rock, Arkansas • Ann Arbor, Michigan • Madison, Wisconsin

Source: ClinicalTrials.gov public record

Updated May 17, 2026 · Synced May 21, 2026, 7:19 PM EDT

Active, not recruiting No phase listed Observational

Long-Term Safety and Efficacy of Spark-Sponsored Gene Therapies in Males With Hemophilia A

NCT03432520

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Conditions: Hemophilia A
Interventions: SPK-8011, SPK-8016; Genetic
Lead sponsor: Spark Therapeutics, Inc.; Industry
Eligibility: 18 Years and older · Male only

Enrollment: 29 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2018 – 2032
U.S. locations: 9
States / cities: Boston, Massachusetts • Madison, Mississippi • Kansas City, Missouri + 5 more

Source: ClinicalTrials.gov public record

Updated Nov 28, 2024 · Synced May 21, 2026, 7:19 PM EDT

Completed Phase 2 Interventional Results available

Dose Confirmation Trial of AAV5-hFIXco-Padua

NCT03489291

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Conditions: Hemophilia B
Interventions: AAV5-hFIXco-Padua (AMT-061); Genetic
Lead sponsor: CSL Behring; Industry
Eligibility: 18 Years and older · Male only

Enrollment: 3 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2018 – 2023
U.S. locations: 4
States / cities: Phoenix, Arizona • Sacramento, California • San Diego, California + 1 more

Source: ClinicalTrials.gov public record

Updated Jun 27, 2024 · Synced May 21, 2026, 7:19 PM EDT

Active, not recruiting Phase 2 Interventional

Long-term Safety and Efficacy Study and Dose-Escalation Substudy of PF 06838435 in Individuals With Hemophilia B

NCT03307980

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Conditions: Hemophilia B
Interventions: PF-06838435 (formerly SPK-9001); Biological
Lead sponsor: Pfizer; Industry
Eligibility: 18 Years to 65 Years · Male only

Enrollment: 21 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2017 – 2029
U.S. locations: 17
States / cities: Sacramento, California • Metairie, Louisiana • New Orleans, Louisiana + 4 more

Source: ClinicalTrials.gov public record

Updated May 11, 2026 · Synced May 21, 2026, 7:19 PM EDT

Completed Phase 3 Interventional Results available

HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients

NCT03569891

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Conditions: Hemophilia B
Interventions: AAV5-hFIXco-Padua, Factor IX (FIX); Genetic · Biological
Lead sponsor: CSL Behring; Industry
Eligibility: 18 Years and older · Male only

Enrollment: 67 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2018 – 2025
U.S. locations: 19
States / cities: Phoenix, Arizona • Little Rock, Arkansas • Los Angeles, California + 14 more

Source: ClinicalTrials.gov public record

Updated Mar 26, 2026 · Synced May 21, 2026, 7:19 PM EDT

Not yet recruiting No phase listed Observational

Liver Biopsy Following Gene Therapy For Hemophilia

NCT05932914

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Conditions: Hemophilia A, Hemophilia B
Interventions: Liver Biopsy; Procedure
Lead sponsor: St. Jude Children's Research Hospital; Other
Eligibility: 18 Years to 80 Years · Male only

Enrollment: 8 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2026 – 2030
U.S. locations: 1
States / cities: Memphis, Tennessee

Source: ClinicalTrials.gov public record

Updated May 19, 2026 · Synced May 21, 2026, 7:19 PM EDT

Enrolling by invitation No phase listed Observational

A Long-Term Follow-Up Study in Severe Hemophilia A Subjects Who Received BMN 270 in a Prior BioMarin Clinical Trial (270-401)

NCT05768386

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Conditions: Hemophilia A
Interventions: Not listed
Lead sponsor: BioMarin Pharmaceutical; Industry
Eligibility: 18 Years and older · Male only

Enrollment: 172 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2023 – 2040
U.S. locations: 13
States / cities: Los Angeles, California • Sacramento, California • San Diego, California + 10 more

Source: ClinicalTrials.gov public record

Updated Jan 11, 2026 · Synced May 21, 2026, 7:19 PM EDT

Recruiting Phase 3 Interventional

Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively

NCT05568719

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Conditions: Hemophilia A, Hemophilia B
Interventions: Testing of hepatic AAV Vector integration; Diagnostic Test
Lead sponsor: Pfizer; Industry
Eligibility: 18 Years and older · Male only

Enrollment: 173 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2022 – 2040
U.S. locations: 14
States / cities: Rancho Cordova, California • Sacramento, California • San Francisco, California + 5 more

Source: ClinicalTrials.gov public record

Updated May 18, 2026 · Synced May 21, 2026, 7:19 PM EDT

Active, not recruiting Phase 1Phase 2 Interventional

Safety, Tolerability, and Efficacy Study of Valoctocogene Roxaparvovec in Hemophilia A With Active or Prior Inhibitors

NCT04684940

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Conditions: Hemophilia A With Inhibitor, Hemophilia A With Anti Factor VIII
Interventions: Valoctocogene roxaparvovec; Biological
Lead sponsor: BioMarin Pharmaceutical; Industry
Eligibility: 18 Years and older · Male only

Enrollment: 10 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2020 – 2029
U.S. locations: 1
States / cities: Los Angeles, California

Source: ClinicalTrials.gov public record

Updated Jul 13, 2025 · Synced May 21, 2026, 7:19 PM EDT

Terminated Phase 1 Interventional

Hemophilia B Gene Therapy With AAV8 Vector

NCT01620801

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Conditions: Hemophilia B
Interventions: AAV8-hFIX19; Biological
Lead sponsor: Spark Therapeutics, Inc.; Industry
Eligibility: 18 Years and older · Male only

Enrollment: 4 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2012 – 2016
U.S. locations: 2
States / cities: Philadelphia, Pennsylvania • Pittsburgh, Pennsylvania

Source: ClinicalTrials.gov public record

Updated Mar 11, 2019 · Synced May 21, 2026, 7:19 PM EDT

Completed Phase 3 Interventional Results available

Single-Arm Study To Evaluate The Efficacy and Safety of Valoctocogene Roxaparvovec in Hemophilia A Patients at a Dose of 4E13 vg/kg

NCT03392974

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Conditions: Hemophilia A
Interventions: Valoctocogene Roxaparvovec; Biological
Lead sponsor: BioMarin Pharmaceutical; Industry
Eligibility: 18 Years and older · Male only

Enrollment: 1 participant
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2018 – 2023
U.S. locations: 1
States / cities: Pittsburgh, Pennsylvania

Source: ClinicalTrials.gov public record

Updated Oct 2, 2023 · Synced May 21, 2026, 7:19 PM EDT

Completed Phase 1Phase 2 Interventional Results available

A Gene Transfer Study for Hemophilia A

NCT03003533

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Conditions: Hemophilia A
Interventions: SPK-8011; Genetic
Lead sponsor: Spark Therapeutics, Inc.; Industry
Eligibility: 18 Years and older · Male only

Enrollment: 25 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2017 – 2023
U.S. locations: 11
States / cities: Sacramento, California • Gainesville, Florida • Boston, Massachusetts + 7 more

Source: ClinicalTrials.gov public record

Updated Dec 29, 2024 · Synced May 21, 2026, 7:19 PM EDT

Recruiting Phase 1Phase 2 Interventional

ASC618 Gene Therapy in Hemophilia A Patients

NCT04676048

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Conditions: Hemophilia A
Interventions: ASC618; Biological
Lead sponsor: ASC Therapeutics; Industry
Eligibility: 18 Years and older · Male only

Enrollment: 12 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2022 – 2026
U.S. locations: 1
States / cities: Little Rock, Arkansas

Source: ClinicalTrials.gov public record

Updated Jan 31, 2023 · Synced May 21, 2026, 7:19 PM EDT

Active, not recruiting Phase 3 Interventional Results available

Study to Evaluate the Efficacy and Safety of PF-07055480 / Giroctocogene Fitelparvovec Gene Therapy in Moderately Severe to Severe Hemophilia A Adults

NCT04370054

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Conditions: Hemophilia A
Interventions: PF-07055480 (giroctocogene fitelparovec): Recombinant AAV2/6 Human Factor VIII Gene Therapy; Biological
Lead sponsor: Pfizer; Industry
Eligibility: 18 Years to 64 Years · Male only

Enrollment: 77 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2020 – 2026
U.S. locations: 19
States / cities: Mountain View, California • Oakland, California • Palo Alto, California + 5 more

Source: ClinicalTrials.gov public record

Updated May 17, 2026 · Synced May 21, 2026, 7:19 PM EDT

Completed Phase 1Phase 2 Interventional Results available

Dose-finding Study of SPK-8016 Gene Therapy in Patients With Hemophilia A to Support Evaluation in Individuals With FVIII Inhibitors

NCT03734588

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Conditions: Adeno-Associated Virus (AAV), Blood Coagulation Disorder, Blood Coagulation Disorders, Inherited, Coagulation Protein Disorders, Factor VIII (FVIII), Factor VIII (FVIII) Deficiency, Factor VIII (FVIII) Gene, Factor VIII (FVIII) Protein, Genetic Diseases, Inborn, Genetic Diseases, X-Linked, Gene Therapy, Gene Transfer, Hematologic Diseases, Hemorrhagic Disorders, Recombinant, Vector, Inhibitors
Interventions: SPK-8016; Genetic
Lead sponsor: Spark Therapeutics, Inc.; Industry
Eligibility: 18 Years and older · Male only

Enrollment: 4 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2019 – 2023
U.S. locations: 11
States / cities: Los Angeles, California • Peoria, Illinois • Ann Arbor, Michigan + 7 more

Source: ClinicalTrials.gov public record

Updated Feb 22, 2024 · Synced May 21, 2026, 7:19 PM EDT

Active, not recruiting Phase 3 Interventional Results available

A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B

NCT03861273

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Conditions: Hemophilia B
Interventions: PF-06838435/ fidanacogene elaparvovec; Biological
Lead sponsor: Pfizer; Industry
Eligibility: 18 Years to 65 Years · Male only

Enrollment: 51 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2019 – 2031
U.S. locations: 16
States / cities: San Francisco, California • Aurora, Colorado • Indianapolis, Indiana + 2 more

Source: ClinicalTrials.gov public record

Updated May 10, 2026 · Synced May 21, 2026, 7:19 PM EDT