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Immunoglobulin

Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)

Phase 3
Waitlist Available
Research Sponsored by CSL Behring
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for the duration of the study, up to approximately 29 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

Summary

The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vital sign changes during each infusion will be evaluated.

Eligible Conditions
  • Common Variable Immunodeficiency
  • CDKL5 Deficiency Disorder
  • Agammaglobulinemia
  • Immunoglobulin G Deficiency

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for the duration of the study, up to approximately 29 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and for the duration of the study, up to approximately 29 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Influence of Infusion Rate on Temporally-Associated AEs
Number of Subjects With Clinically Significant Changes in Vital Signs.
Rate of AEs by Severity and Relationship
+1 more
Secondary study objectives
Annualized Rate of Acute Serious Bacterial Infections.
Annualized Rate of Any Infection.
Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations.

Side effects data

From 2008 Phase 3 trial • 55 Patients • NCT00322556
38%
Headache
25%
Sinusitis
22%
Cough
20%
Nausea
18%
Diarrhea
16%
Pharyngolaryngeal pain
15%
Pyrexia
15%
Vomiting
11%
Eczema
11%
Rash
11%
Upper respiratory tract infection
11%
Back pain
9%
Epistaxis
9%
Fatigue
9%
Nasopharyngitis
9%
Pain
7%
Dizziness
7%
Hypertension
7%
Insomnia
7%
Rhinorrhea
5%
Urticaria
5%
Pneumonia
5%
Abdominal pain
5%
Abdominal pain upper
5%
Asthma
5%
Bronchitis
5%
Chest pain
5%
Chills
5%
Conjunctivitis
5%
Ear pain
5%
Gastroenteritis viral
5%
Influenza-like illness
5%
Joint sprain
5%
Procedural pain
5%
Toothache
2%
Small intestinal obstruction
2%
Intestinal obstruction
2%
Splenomegaly
2%
Giardiasis
2%
Cellulitis
2%
Angioedema
2%
Aggression
2%
Transient ischemic attack
2%
Otitis externa fungal
2%
Muscular weakness
2%
Joint effusion
2%
Clostridial infection
2%
Ileostomy closure
2%
Gastrointestinal hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
IgPro10

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: IgPro10Experimental Treatment1 Intervention
See Intervention Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Human immunoglobulin G
FDA approved

Find a Location

Who is running the clinical trial?

CSL BehringLead Sponsor
201 Previous Clinical Trials
1,205,108 Total Patients Enrolled
6 Trials studying Common Variable Immunodeficiency
281 Patients Enrolled for Common Variable Immunodeficiency
Program CoordinatorStudy DirectorCSL Behring
~3 spots leftby Jan 2026
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