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NGGT006 Gene Therapy for Homozygous Familial Hypercholesterolemia

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 4 months later Nov 30, 2024 → Mar 30, 2027
See other at-risk trials from First Affiliated Hospital Xi'an Jiaotong University

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Nov 30, 2024 to Mar 30, 2027v5 Show 4 more changesShow less
    • Enrollment increased: 12 → 21 participants
    • Study completion pushed from Nov 2028 to Mar 30, 2031
    • Eligibility criteria expanded, about 28 words
    • Study description revised
  2. Primary completion date changed from estimate of Nov 2024 to Nov 30, 2024
    • Eligibility criteria revised
    • Secondary endpoints: 6 to 5
    • Study description expanded, about 16 words
    v4
  3. Eligibility criteria revisedv3
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Start date changed from estimate of Nov 2023 to Oct 29, 2023
    • Eligibility criteria revised
    • Secondary endpoints: 1 to 6
    • Site details revised
    • Study description shortened, about 2 words
    • Study title expanded, about 1 word
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is an early phase 1, open-label, single-center, dose-escalation, pilot trial to evaluate the safety and efficacy of an intravenous infusion of NGGT006 in homozygous familial hypercholesterolemia (HoFH) patients with LDLR mutations. NGGT006 is an adeno-associated viral (AAV) vector carrying codon-optimized human LDLR gene, driving the expression of LDLR protein with normal function and promoting the clearance of low-density lipoprotein cholesterol (LDL-C).
Trial Details
NCT Number NCT06125847
Lead Sponsor First Affiliated Hospital Xi'an Jiaotong University
Conditions
(from sponsor)		 Homozygous Familial Hypercholesterolemia
Related terms Homozygous Familial Hypercholesterolemia
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov