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Home › Conditions › Primary Immunodeficiency

Primary Immunodeficiency

0 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Primary Immunodeficiency

11 trials tracked for Primary Immunodeficiency: 10 in phase 3 or 4 and 2 with published results. The most-cited published study has 9 citations.

11Trials tracked
10Phase 3 & 4
0Recruiting
2With published results
Phase distribution
Phase 4 3 Phase 3 7 Phase 2 1
  1. Phase 4 Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary Immunodeficiency (PID) Completed · 9 cited
  2. Phase 3 Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency Completed · 7 cited
  3. Phase 4 A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency Completed
  4. Phase 4 Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency Completed
  5. Phase 3 Efficacy, Pharmacokinetics, Safety, and Tolerability of IGSC 20% in Subjects With Primary Immunodeficiency Completed
  6. Phase 3 CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL Completed
Show 5 more trials
  1. Phase 3 Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID) Completed
  2. Phase 3 Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10% Completed
  3. Phase 3 A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency Completed
  4. Phase 3 Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases. Completed
  5. Phase 2 Bilateral Orthotopic Lung Transplant - Bone Marrow Transplant Completed

Showing the 11 most-cited and recently-updated of 11 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found For clinicians

Primary Immunodeficiency: what the trials found

Multiple intravenous immunoglobulin (IVIG) products, including IgPro20 1, IGSC 20% [2, 9], GAMUNEX-C [3, 5], IGIV-C 10% 4, Kedrion IVIG 10% 7, Octanorm 16.5% 8, and Gammaplex 10, have been evaluated for the management of infections in patients with primary immunodeficiency diseases.

Clinical outcomes associated with these interventions include significant reductions in infection-related morbidity. Specifically, Gammaplex was associated with a reduction in serious, acute, bacterial infections (SABIs) to 0 per subject per year (p=0.01) 10. Other IVIG formulations demonstrated varying rates of days spent on antibiotics and missed work or school due to infection; for instance, IGSC 20% showed mean rates of 7.451 to 44.846 days on antibiotics per year 9, while Kedrion IVIG 10% was associated with an average of 23.3 days on therapeutic antibiotics and approximately 3.4 days unable to perform normal daily activities 7.

Treatment response rates for IgPro20 were reported between 66.7% and 86.7% 1. Additionally, studies using IGIV-C 10% 4 and Immune Globulin Intravenous 6 established the clinical utility of these agents in this population.

Recent results — preliminary, needs further review

  • [] CD3/CD19 neg allogeneic BMT: Reported 4 grade 4 or 5 events potentially attributable to Rituximab (not yet corroborated).

For the clinician treating this condition

  • Various IVIG formulations (e.g., Gammaplex, IGSC, Kedrion) are established for treating infections in primary immunodeficiency patients [1, 2, 3, 7, 9, 10].
  • Gammaplex demonstrated a statistically significant reduction in serious, acute, bacterial infections (SABIs) to zero per subject per year (p=0.01) 10.
  • Clinical outcomes for IVIG therapies include measurable impacts on the duration of antibiotic therapy and the number of days missed from work or school due to infection [7, 9].

AI synthesis of 7 cited trials, updated Jul 5, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
No published articles yet for this condition. Check back soon.