A Phase 3 interventional study of Immunoglobulins Intravenous (Human) in Agammaglobulinemia, IgG Deficiency and Common Variable Immunodeficiency, sponsored by CSL Behring. Completed at 10 sites in United States. Open to participants aged 4 Years to 71 Years. Per ClinicalTrials.gov, last updated 2012-10-26.
Sponsored by CSL Behring (part of CSL Limited) · Phase 3, Interventional, and Treatment
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.
38 studies on the registry are indexed under Agammaglobulinemia; 10 are open to participants now.
This study's enrollment of 55 is above the median of 45 across 31 interventional studies indexed under Agammaglobulinemia.
Browse Agammaglobulinemia studies →CSL Behring is the lead sponsor of 145 studies on the registry; 17 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 17 (71%) have results posted.
First submitted after CSL Behring became part of CSL Limited.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Patients with CVID (Common Variable Immunodeficiency) or XLA (X-linked agammaglobulinemia) who:
Participated in the Phase III clinical study with intravenous IgPro10 (study number ZLB03_002CR) at 3- or 4- weekly intervals for 12 months (referred to as 'old' subjects)
OR
Were ≥ 6 years of age, were on other stable intravenous immunoglobulin therapy (200-800 mg IgG per kg body weight) at 3- or 4-week intervals for at least 6 months, AND were interested in participating in the Phase III clinical study with subcutaneous IgPro20 (study number ZLB04_009CR) (referred to as 'new' subjects)
Written
Key Exclusion Criteria:
Diagnosis of epilepsia
Insulin dependent diabetes
Administration of (daily ≥ 0.15 mg prednisone equivalent/kg/day) or other drugs
History of cardiac insufficiency ( III/IV), cardiomyopathy, congestive heart failure, severe hypertension
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
See Intervention Description
Drug: Immunoglobulins Intravenous (Human)
Liquid formulation; treatment schedule every 3 or 4 weeks using an individualized regimen with a dose of 0.2 - 0.8 g IgG per kg bw
The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs).
AEs were considered temporally-associated AEs if they occurred during the infusion or in the period from the start of the infusion until either 48 or 72 hours after the end of the infusion.
Time frame: During each infusion, and within 48 or 72 hours after the end of each infusion.
Influence of Infusion Rate on Temporally-Associated AEs
The total and most frequent (1% or more) number of infusions for which subjects experienced temporally-associated AEs occurring within 72 hours of infusion, by infusion rate (≤ 4 mg/kg/min, ≤ 8 mg/kg/min, and \> 8 and ≤ 12 mg/kg/min). AEs were considered to be temporally-associated AEs if they occurred in the period from the start of the infusion until 72 hours after the end of the infusion.
Time frame: Within 72 hours after each infusion
Rate of AEs by Severity and Relationship
The AE rate was the number of AEs over the number of infusions administered. Mild AEs: Did not interfere with daily activities; Moderate AEs: Interfered with routine daily activities; Severe AEs: Impossible to perform routine daily activities. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.
Time frame: For the duration of the study, up to approximately 29 months
Number of Subjects With Clinically Significant Changes in Vital Signs.
Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.
Time frame: Before, during, and after each infusion.
Annualized Rate of Acute Serious Bacterial Infections.
The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. Acute serious bacterial infections included pneumonia, bacteremia / septicemia, osteomyelitis / septic arthritis, bacterial meningitis, and visceral abscess.
Time frame: For the duration of the study, up to approximately 29 months
Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Illness.
Time frame: For the duration of the study, up to approximately 29 months.
Number of Days of Hospitalization.
Time frame: For the duration of the study, up to approximately 29 months
Annualized Rate of Any Infection.
The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. Infections were classified as all AEs with the system organ class "infections and infestations" and AEs with the preferred term "conjunctivitis".
Time frame: For the duration of the study, up to approximately 29 months.
Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations.
Mean IgG trough concentration. For this analysis, each subject's values were first aggregated to their median and the median values were then analyzed.
Time frame: Prior to each infusion; every 3 or 4 weeks depending upon the dosing schedule.
| Milestone | IgPro10 |
|---|---|
| Started | 55 |
| Completed | 43 |
| Not completed | 12 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Other reason | 7 |
AEs were considered temporally-associated AEs if they occurred during the infusion or in the period from the start of the infusion until either 48 or 72 hours after the end of the infusion.
| Proportion of infusions | IgPro10 |
|---|---|
| During infusion | 0.073 |
| Within 48 hours after infusion | 0.141 |
| Within 72 hours after infusion | 0.150 |
The total and most frequent (1% or more) number of infusions for which subjects experienced temporally-associated AEs occurring within 72 hours of infusion, by infusion rate (≤ 4 mg/kg/min, ≤ 8 mg/kg/min, and \> 8 and ≤ 12 mg/kg/min). AEs were considered to be temporally-associated AEs if they occurred in the period from the start of the infusion until 72 hours after the end of the infusion.
| Infusions | IgPro10 (≤ 4 mg/kg/Min) | IgPro10 (≤ 8 mg/kg/Min) | IgPro10 (> 8 to ≤ 12 mg/kg/Min) |
|---|---|---|---|
| All temporally-associated AEs | 23 | 153 | 30 |
| Headache | 10 | 54 | 2 |
| Pyrexia | 0 | 9 | 1 |
| Nausea | 0 | 8 | 2 |
| Back pain | 0 | 8 | 0 |
| Chills | 0 | 7 | 0 |
| Pain | 0 | 6 | 0 |
| Anaemia | 1 | 0 | 0 |
| Constipation | 2 | 0 | 0 |
| Fatigue | 3 | 0 | 0 |
| Influenza like illness | 3 | 1 | 0 |
| Myalgia | 1 | 0 | 0 |
| Pharyngolaryngeal pain | 1 | 1 | 2 |
| Eczema | 1 | 0 | 0 |
| Night sweats | 1 | 0 | 0 |
The AE rate was the number of AEs over the number of infusions administered. Mild AEs: Did not interfere with daily activities; Moderate AEs: Interfered with routine daily activities; Severe AEs: Impossible to perform routine daily activities. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.
| AEs per infusion | IgPro10 |
|---|---|
| All mild AEs | 0.467 |
| All moderate AEs | 0.280 |
| All severe AEs | 0.058 |
| Unrelated AEs | 0.610 |
| Possibly related AEs | 0.088 |
| Probably related AEs | 0.048 |
| Related AEs | 0.060 |
| At least possibly related mild AEs | 0.121 |
| At least possibly related moderate AEs | 0.062 |
| At least possibly related severe AEs | 0.013 |
| Unrelated mild AEs | 0.346 |
| Unrelated moderate AEs | 0.218 |
| Unrelated severe AEs | 0.045 |
The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. Acute serious bacterial infections included pneumonia, bacteremia / septicemia, osteomyelitis / septic arthritis, bacterial meningitis, and visceral abscess.
| Infections per subject year | IgPro10 |
|---|---|
| Annualized Rate of Acute Serious Bacterial Infections. | 0.018 |
| Days | IgPro10 |
|---|---|
| Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Illness. | 8.5 (0.0 to 104.0) |
| Days | IgPro10 |
|---|---|
| Number of Days of Hospitalization. | 0.0 (0.0 to 17.0) |
The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. Infections were classified as all AEs with the system organ class "infections and infestations" and AEs with the preferred term "conjunctivitis".
| Infections per subject year | IgPro10 |
|---|---|
| Annualized Rate of Any Infection. | 1.600 |
Mean IgG trough concentration. For this analysis, each subject's values were first aggregated to their median and the median values were then analyzed.
| g/L | IgPro10 |
|---|---|
| Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations. | 9.72 (5.72 to 18.01) |
Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.
| Participants | IgPro10 |
|---|---|
| Number of Subjects With Clinically Significant Changes in Vital Signs. | 0 |
Collected over For the duration of the study, up to approximately 29 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IgPro10 | — | 11/55 (20%) | 48/55 (87.3%) |
| Event | IgPro10 |
|---|---|
| Clostridial infectionInfections and infestations | 1/55 |
| Ileostomy closureSurgical and medical procedures | 1/55 |
| Gastrointestinal hemorrhageGastrointestinal disorders | 1/55 |
| Small intestinal obstructionGastrointestinal disorders | 1/55 |
| Intestinal obstructionGastrointestinal disorders | 1/55 |
| SplenomegalyBlood and lymphatic system disorders | 1/55 |
| GiardiasisInfections and infestations | 1/55 |
| PneumoniaInfections and infestations | 1/55 |
| SinusitisInfections and infestations | 1/55 |
| CellulitisInfections and infestations | 1/55 |
| Event | IgPro10 |
|---|---|
| HeadacheNervous system disorders | 21/55 |
| SinusitisInfections and infestations | 14/55 |
| CoughRespiratory, thoracic and mediastinal disorders | 12/55 |
| NauseaGastrointestinal disorders | 11/55 |
| DiarrheaGastrointestinal disorders | 10/55 |
| Pharyngolaryngeal painRespiratory, thoracic and mediastinal disorders | 9/55 |
| PyrexiaGeneral disorders | 8/55 |
| VomitingGastrointestinal disorders | 8/55 |
| Back painMusculoskeletal and connective tissue disorders | 6/55 |
| EczemaSkin and subcutaneous tissue disorders | 6/55 |
| Age Continuous(years) | IgPro10 |
|---|---|
| Mean | 30 ± 21 |
| Age, Customized(participants) | IgPro10 |
|---|---|
| 3 to < 12 years | 13 |
| 12 to < 16 years | 8 |
| 16 to < 65 years | 30 |
| >= 65 years | 4 |
| Sex: Female, Male(Participants) | IgPro10 |
|---|---|
| Female | 29 |
| Male | 26 |
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Immunoglobulins