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A Study Investigating Intravenous Human Normal Immune Globulin 10% in Adults With Stiff Person Syndrome

StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Re-verified, no change to tracked fieldsv3
  2. Interventions: Human Albumin 5% (Biological), Kedrion IVIg 10% (Biological) to Human Albumin (Biological), Kedrion IVIg 10% (Biological)
    • Eligibility criteria shortened, about 30 words
    • Secondary endpoints: 11 to 10
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Kedrion S.p.A.
6 trials monitored
See 1 trial at risk
The purpose of this study is to evaluate the efficacy and safety of QIVIGY (Intravenous Human Normal Immune Globulin 10%) compared with placebo in adult participants with stiff person syndrome (SPS).
Trial Details
NCT Number NCT07552987
Lead Sponsor Kedrion S.p.A.
Conditions
(from sponsor)		 Stiff Person Syndrome
Related terms Autoimmune Diseases, Nervous System Diseases, Stiff-Person Syndrome
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov