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Study to Evaluate Sepofarsen in Subjects With Leber Congenital Amaurosis (LCA) Type 10 (HYPERION)

Study acronym: HYPERION
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 16 to 17v10
  2. Study sites: 14 to 16v9
  3. Eligibility criteria expanded, about 6 words
    • Secondary endpoints: 17 to 18
    v8
  4. Study sites: 13 to 14v7
  5. Study sites: 12 to 13v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 8 to 12v5
  2. Study sites: 7 to 8
    • Start date changed from estimate of Aug 2025 to Jun 4, 2025
    v4
  3. Study sites: 3 to 7v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 2025 to Aug 2025
    • Study sites: 0 to 3
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this double-masked, randomized, placebo-controlled, paired-eye study is to evaluate the efficacy, safety and tolerability of Sepofarsen in subjects with Leber Congenital Amaurosis (LCA) due to the c.2991+1655A\>G (p.Cys998X) mutation in the CEP290.
Trial Details
NCT Number NCT06891443
Lead Sponsor Laboratoires Thea
Collaborators: Sepul Bio
Conditions
(from sponsor)		 Leber Congenital Amaurosis 10, Blindness, Leber Congenital Amaurosis, Sensation Disorders, Vision Disorder, Neurological Manifestations, Eye Diseases, Hereditary, Eye Diseases +2 more
Related terms Blindness, Eye Abnormalities, Eye Diseases, Eye Diseases, Hereditary, Leber Congenital Amaurosis, Leber Congenital Amaurosis 10, Meckel Syndrome, Type 4, Neurologic Manifestations, Optic Atrophy, Hereditary, Leber, Retinal Diseases, Sensation Disorders, Vision Disorders
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov