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NCT04502030

Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients With Chronic Lymphocytic Leukemia ("PRO-SID" Study)

StatusCompleted
PhasePhase 3
SponsorOctapharma
Primary completion
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Record History

All 42 versions: 38 with changes below, 4 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Results posted: Nov 2, 2026 Show 4 more changesShow less
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints revised (3)
    • Primary endpoint revised
    • Site details revised at 1 of 84 sites
  2. Site details revised at 5 of 84 sitesv41
  3. Trial status: Active, Not Recruiting to Completed
    • Primary and study completion dates changed from estimate of Oct 2025 to Sep 19, 2025
    v40
  4. Enrollment target: 240 to 247v37
  5. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 85 to 84
    v36
Show 32 earlier versionsHide 32 earlier versions
  1. Site details revised at 72 of 85 sitesv35
  2. Study sites: 84 to 85v34
  3. Study sites: 83 to 84v33
  4. Site details revised at 4 of 83 sitesv32
  5. Study sites: 81 to 83
    • Primary and study completion dates: Aug 2025 to Oct 2025
    v30
  6. Site details revised at 3 of 81 sitesv29
  7. Site details revised at 1 of 81 sitesv28
  8. Primary and study completion dates: Oct 2024 to Aug 2025v27
  9. Study sites: 78 to 81v26
  10. Site details revised at 60 of 78 sitesv25
  11. Site details revised at 2 of 78 sitesv24
  12. Site details revised at 1 of 78 sitesv23
  13. Study sites: 72 to 78v22
  14. Site details revised at 1 of 72 sitesv21
  15. Study sites: 66 to 72v20
  16. Study sites: 59 to 66v19
  17. Study sites: 58 to 59v18
  18. Study sites: 56 to 58v17
  19. Site details revised at 1 of 56 sitesv16
  20. Study sites: 53 to 56v15
  21. Study sites: 49 to 53v14
  22. Primary and study completion dates: Dec 2026 to Oct 2024
    • Eligibility criteria expanded, about 1 word
    v13
  23. Site details revised at 1 of 49 sitesv12
  24. Study sites: 50 to 49v11
  25. Study sites: 49 to 50v10
  26. Primary and study completion dates: Sep 2023 to Dec 2026
    • Study sites: 48 to 49
    v9
  27. Study sites: 42 to 48v8
  28. Site details revised at 7 of 42 sitesv6
  29. Site details revised at 11 of 42 sitesv5
  30. Site details revised at 13 of 42 sitesv4
  31. Study sites: 41 to 42v3
  32. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2020 to Oct 5, 2020
    • Site details revised at 41 of 41 sites
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Occurrence of Major Infections
Timeframe: From first treatment to the occurrence of a major infection or to the end of study visit. The median study duration of participants completing the study was 366 days. For delayed end of study visits 3 participants stayed in the study for 407 days or more.

Secondary (3)

Overall Infection Rate
Frequency of Prophylaxis With Anti-infectives
Duration of Prophylaxis With Anti-infectives

Arms and interventions

PanzygaExperimental
PlaceboPlacebo comparator

Biologicals: Panzyga

Other: Placebo

Sites

84 sites in 12 countries

United States 15, Russia 14, Poland 11, Italy 10, Greece 6, Hungary 5, Spain 5, Turkey (Türkiye) 5, Germany 4, Czechia 3, Denmark 3, Israel 3