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Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency

Study acronym: SPARTA-OLE
StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv32
  2. Study sites: 27 to 28v31
  3. 3 versions Re-verified since Mar 6, 2024, no change to tracked fieldsv28-v30
  4. Primary completion date: Jul 2028 to Sep 2028
    • Study completion date: Jul 2028 to Feb 2029
    v27
  5. Study sites revised (27)v26
Show 24 earlier versionsHide 24 earlier versions
  1. Enrollment target: 250 to 290v25
  2. Study sites: 25 to 27v24
  3. Primary and study completion dates: Apr 2028 to Jul 2028v23
  4. 2 versions Re-verified since Mar 10, 2023, no change to tracked fieldsv21-v22
  5. Enrollment target: 192 to 250v20
  6. Re-verified, no change to tracked fieldsv19
  7. Primary and study completion dates: Apr 2024 to Apr 2028
    • Trial status: Recruiting to Enrolling by Invitation
    • Site details revised at 25 of 25 sites
    v18
  8. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 25 of 25 sites
    v17
  9. Primary and study completion dates: Jul 2027 to Apr 2024
    • Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 250 to confirmed 192
    v16
  10. Re-verified, no change to tracked fieldsv15
  11. Study sites: 24 to 25v14
  12. Re-verified, no change to tracked fieldsv13
  13. Primary and study completion dates: Dec 2025 to Jul 2027v12
  14. Study sites: 23 to 24
    • Secondary endpoints: 5 to 6
    v11
  15. Study sites: 22 to 23v10
  16. Study sites: 21 to 22v9
  17. Study sites: 20 to 21v8
  18. Study sites: 19 to 20v7
  19. Study sites: 15 to 19v6
  20. Primary completion date: Jul 2018 to Dec 2025
    • Study completion date: Jul 2023 to Dec 2025
    v5
  21. Primary endpoints: 2 to 3v4 Show 4 more changesShow less
    • Study sites: 6 to 15
    • Secondary endpoints revised (5)
    • Study description expanded, about 6 words
    • Eligibility criteria expanded, about 3 words
  22. Study sites: 4 to 6v3
  23. Primary endpoints: 5 to 2
    • Eligibility criteria shortened, about 7 words
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Grifols Therapeutics LLC
7 trials monitored
See 1 trial at risk
COPD
1,119 trials monitored
See 34 trials at risk
This is a 2-year open-label, multicenter extension of the double-blind, placebo-controlled GTi1201 study. The purpose of this study is to obtain an additional 2 years of safety data for intravenously administered Alpha1-MP 60 mg/kg/week in subjects with alpha1-antitrypsin deficiency (AATD).
Trial Details
NCT Number NCT02796937
Lead Sponsor Grifols Therapeutics LLC
Conditions
(from sponsor)		 Pulmonary Emphysema in Alpha-1 Antitrypsin Deficiency
Related terms alpha 1-Antitrypsin Deficiency, Pulmonary Emphysema
Enrollment 290 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov