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Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)

Study acronym: SPARTA
StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date: Nov 2013 to Apr 1, 2014 Show 6 more changesShow less
    • Trial completed
    • Study completion date changed from estimate of Jan 2027 to Aug 5, 2026
    • Primary completion date changed from estimate of Aug 2026 to Jul 7, 2026
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 4 of 9 entries
    • Publications: details revised at 1 of 1 entry
  2. Re-verified, no change to tracked fieldsv42
  3. Study sites revised (52)v41
  4. Study sites: 51 to 52v40
  5. Study sites: 35 to 51v39
Show 37 earlier versionsHide 37 earlier versions
  1. Study completion date: Aug 2026 to Jan 2027v38
  2. Primary and study completion dates: Jul 2026 to Aug 2026v37
  3. Study sites revised (35)v36
  4. Enrollment target: 341 to 345v35
  5. Enrollment target: 339 to 341
    • Primary and study completion dates: Jun 2026 to Jul 2026
    v34
  6. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 51 to 35
    v33
  7. Site contacts updated at 1 of 51 sitesv32
  8. Site details revised at 2 of 51 sitesv31
  9. 2 versions Re-verified since Dec 7, 2022, no change to tracked fieldsv29-v30
  10. Primary and study completion dates: Jun 2025 to Jun 2026v28
  11. Site details revised at 5 of 51 sitesv27
  12. Study sites: 50 to 51v26
  13. Site contacts updated at 1 of 50 sitesv25
  14. Site details revised at 1 of 50 sitesv24
  15. Secondary endpoints revised (9)
    • Site details revised at 2 of 50 sites
    v23
  16. Primary and study completion dates: Nov 2023 to Jun 2025
    • Study sites: 51 to 50
    • Secondary endpoints: 5 to 9
    v22
  17. Study sites: 49 to 51v21
  18. Study sites: 48 to 49v20
  19. Site details revised at 1 of 48 sitesv19
  20. Study sites: 47 to 48v18
  21. Study sites: 46 to 47v17
  22. Site details revised at 1 of 46 sitesv16
  23. Site details revised at 2 of 46 sitesv15
  24. Study sites: 44 to 46v14
  25. Primary and study completion dates: Aug 2021 to Nov 2023v13
  26. Interventions: 0.9% Sodium Chloride for Injection, USP (Other), Alpha1-proteinase inhibitor (human), modified process (Alpha-1 MP) (Biological) to 0.9% Sodium Chloride for Injection, USP (Other), Alpha-1 MP (Biological)
    • Secondary endpoints: details revised at 3 of 5 entries
    • Study sites revised (44)
    v12
  27. Study sites: 43 to 44v11
  28. Site details revised at 12 of 43 sitesv10
  29. Re-verified, no change to tracked fieldsv9
  30. Study sites: 44 to 43v8
  31. Study sites: 33 to 44
    • Eligibility criteria expanded, about 7 words
    v7
  32. Study sites: 29 to 33v6
  33. Study sites: 7 to 29v5
  34. Study sites: 2 to 7v4
  35. Study sites revised (2)v3
  36. Trial status: Not Yet Recruiting to Recruiting
    • Study sites revised (2)
    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 multi-center, randomized, placebo-controlled, double blind clinical study to assess the efficacy and safety of two separate dose regimens of Alpha-1 MP versus placebo for 156 weeks (i.e., 3 years) using computed tomography (CT) of the lungs as the main measure of efficacy. The two Alpha-1 MP doses to be tested are 60 mg/kg and 120 mg/kg administered weekly by IV infusion for 156 weeks. The study consists of an optional pre-screening phase, Screening Phase, a 156-week Treatment Phase, and an End of Study Visit at Week 160.
Trial Details
NCT Number NCT01983241
Lead Sponsor Grifols Therapeutics LLC
Conditions
(from sponsor)		 Pulmonary Emphysema in Alpha-1 PI Deficiency
Related terms alpha 1-Antitrypsin Deficiency, Pulmonary Emphysema
Enrollment 345 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov