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IVIG in the Treatment of Autoimmune Small Fiber Neuropathy With TS-HDS, FGFR-3, or Plexin D1 Antibodies

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Site details revisedv26
  2. Lead sponsor: Henry Ford Health System to Endeavor Healthv25 Show 5 more changesShow less
    • Trial status: Active, Not Recruiting to Recruiting
    • Primary completion date: Dec 31, 2026 to Aug 27, 2027
    • Study completion date: Apr 30, 2027 to Feb 28, 2028
    • Eligibility criteria expanded, about 33 words
    • Study site revised
  3. Re-verified, no change to tracked fieldsv24
  4. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Dec 2026 to Dec 31, 2026
    • Study completion date: Apr 2027 to Apr 30, 2027
    • Site details revised
    v23
  5. Re-verified, no change to tracked fieldsv22
Show 20 earlier versionsHide 20 earlier versions
  1. Publications: 17 to 18v21
  2. Eligibility criteria expanded, about 25 wordsv20
  3. Start date changed from estimate of Dec 2023 to Dec 15, 2023v19
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 2024 to Dec 2023
    • Site details revised
    v18
  5. Start date: Nov 2023 to Jan 2024
    • Primary completion date: Oct 2026 to Dec 2026
    • Study completion date: Mar 2027 to Apr 2027
    • Eligibility criteria expanded, about 6 words
    v17
  6. Primary completion date: Sep 2026 to Oct 2026
    • Start date: Oct 2023 to Nov 2023
    v16
  7. Eligibility criteria expanded, about 15 wordsv15
  8. Lead sponsor: Loyola University to Henry Ford Health Systemv14 Show 6 more changesShow less
    • Start date: Aug 1, 2023 to Oct 2023
    • Primary completion date: Jul 30, 2026 to Sep 2026
    • Study completion date: Jan 31, 2027 to Mar 2027
    • Eligibility criteria expanded, about 7 words
    • Publications: 19 to 17
    • Study description shortened, about 2 words
  9. Start date: May 1, 2023 to Aug 1, 2023
    • Primary completion date: Jun 30, 2026 to Jul 30, 2026
    • Study completion date: Dec 31, 2026 to Jan 31, 2027
    • Study site revised
    v13
  10. Study description expanded, about 12 words
    • Study title expanded, about 2 words
    v12
  11. Primary completion date: Jun 30, 2025 to Jun 30, 2026
    • Start date: Oct 1, 2022 to May 1, 2023
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    • Publications: 18 to 19
    v11
  12. Trial status: Suspended to Not Yet Recruitingv10 Show 8 more changesShow less
    • Start date: Jul 1, 2022 to Oct 1, 2022
    • Interventions: Gammagard IVIG (Drug), Placebo (Drug) to Panzyga IVIG (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints: 5 to 4
    • Study description shortened, about 67 words
    • Site contact updated
    • Collaborator revised
    • Publications: 16 to 18
  13. Primary completion date: Sep 1, 2023 to Jun 30, 2025
    • Start date: Jan 1, 2022 to Jul 1, 2022
    • Study completion date: Sep 1, 2024 to Dec 31, 2025
    v9
  14. Study site revisedv8
  15. Re-verified, no change to tracked fieldsv7
  16. Trial status: Not Yet Recruiting to Suspended Sponsor's reason: Recruitment not started at Loyola, PI leaving Loyola, PI may resume at next affiliating instituation.
    • Start date: Sep 1, 2020 to Jan 1, 2022
    • Site contact updated
    v6
  17. Primary completion date: Jan 15, 2023 to Sep 1, 2023
    • Start date: May 1, 2020 to Sep 1, 2020
    • Study completion date: Jan 15, 2024 to Sep 1, 2024
    • Site contact updated
    v5
  18. Start date: Jan 15, 2020 to May 1, 2020v4
  19. Lead sponsor: Lawrence Zeidman to Loyola Universityv3
  20. Primary endpoint revised
    • Secondary endpoints revised (5)
    • Publications: 15 to 16
    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.
This study will enroll patients with small fiber neuropathy (SFN). The study will look at an intravenous immunoglobulin (IVIG) called Panzyga. Panzyga is approved by the FDA as a therapy for Primary humoral immunodeficiency (PI) in patients 2 years of age and older; Chronic immune thrombocytopenia (ITP) in adults and Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. It has not been approved by the FDA for use in SFN. There is mounting evidence that Intravenous Immunoglobulin (IVIG) can cause pain reduction and improve objective nerve fiber densities on skin biopsies in great numbers in SFN patients. The primary outcome is quantified improvement in intraepidermal nerve fiber density (IENFD) on repeat skin punch biopsy after 6 months of IVIG treatment.
Trial Details
NCT Number NCT04153422
Lead Sponsor Endeavor Health
Collaborators: Octapharma USA, Inc.
Conditions
(from sponsor)		 Small Fiber Neuropathy, Autoimmune Small Fiber Neuropathy, Inflammatory Polyneuropathy, Immune-Mediated Neuropathy
Related terms Neuritis, Small Fiber Neuropathy
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov