Trial · NCT00322556
Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
NCT00322556, Phase 3, Completed, CSL Behring; results first posted 2012-10-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID). Trials, record NCT00322556. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00322556
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
- NCT number
- NCT00322556
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 55 participants, actual
- Lead sponsor
- CSL Behring
- Conditions
- Agammaglobulinemia, IgG Deficiency, Common Variable Immunodeficiency
- Interventions
- Immunoglobulins Intravenous (Human)
- First posted
- 2006-05-08
- Last updated
- 2012-10-26
- Results first posted
- 2012-10-26
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs). | During each infusion, and within 48 or 72 hours after the end of each infusion. | 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. |
| Primary | Influence of Infusion Rate on Temporally-Associated AEs | Within 72 hours after each infusion | 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. |
| Primary | Rate of AEs by Severity and Relationship | For the duration of the study, up to approximately 29 months | 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. |
| Primary | Number of Subjects With Clinically Significant Changes in Vital Signs. | Before, during, and after each infusion. | Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature. |
| Secondary | Annualized Rate of Acute Serious Bacterial Infections. | For the duration of the study, up to approximately 29 months | 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. |
| Secondary | Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Illness. | For the duration of the study, up to approximately 29 months. | |
| Secondary | Number of Days of Hospitalization. | For the duration of the study, up to approximately 29 months | |
| Secondary | Annualized Rate of Any Infection. | For the duration of the study, up to approximately 29 months. | 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". |
| Secondary | Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations. | Prior to each infusion; every 3 or 4 weeks depending upon the dosing schedule. | Mean IgG trough concentration. For this analysis, each subject's values were first aggregated to their median and the median values were then analyzed. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs). | During each infusion, and within 48 or 72 hours after the end of each infusion. | The Safety Data Set (SDS) comprised all subjects treated with the study drug. | Proportion of infusions | NUMBER |
| PRIMARY | Influence of Infusion Rate on Temporally-Associated AEs | Within 72 hours after each infusion | 'New subjects' could receive IgPro10 at up to 4 mg/kg/min. 'Old' subjects (ie, those treated with the study drug who participated in a preceding, pivotal, Phase III clinical study with intravenous IgPro10 \[study number ZLB03\_002CR, NCT00168025\]), could receive IgPro10 at up to 12 mg/kg/min at the discretion of the Investigator. | Infusions | NUMBER |
| PRIMARY | Rate of AEs by Severity and Relationship | For the duration of the study, up to approximately 29 months | The SDS comprised all subjects treated with the study drug. | AEs per infusion | NUMBER |
| SECONDARY | Annualized Rate of Acute Serious Bacterial Infections. | For the duration of the study, up to approximately 29 months | The Intention-To-Treat (ITT) data set comprised all subjects treated with the study drug | Infections per subject year | NUMBER |
| SECONDARY | Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Illness. | For the duration of the study, up to approximately 29 months. | The ITT data set comprised all subjects treated with the study drug. The patient diary (in which the number of days was recorded) was not available for 1 subject so the analyzed population was reduced from 55 to 54 subjects for this outcome measure. | Days | MEDIAN |
| SECONDARY | Number of Days of Hospitalization. | For the duration of the study, up to approximately 29 months | The ITT data set comprised all subjects treated with the study drug. The patient diary (in which the number of days was recorded) was not available for 1 subject so the analyzed population was reduced from 55 to 54 subjects for this outcome measure. | Days | MEDIAN |
| SECONDARY | Annualized Rate of Any Infection. | For the duration of the study, up to approximately 29 months. | The ITT data set comprised all subjects treated with the study drug. | Infections per subject year | NUMBER |
| SECONDARY | Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations. | Prior to each infusion; every 3 or 4 weeks depending upon the dosing schedule. | The ITT data set comprised all subjects treated with the study drug for which serum IgG information was available. | g/L | MEAN |
| PRIMARY | Number of Subjects With Clinically Significant Changes in Vital Signs. | Before, during, and after each infusion. | The Safety Data Set (SDS) comprised all subjects treated with the study drug. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group67
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs). | IgPro10 | During infusion | 0.073 | Proportion of infusions | |
| The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs). | IgPro10 | Within 48 hours after infusion | 0.141 | Proportion of infusions | |
| The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs). | IgPro10 | Within 72 hours after infusion | 0.150 | Proportion of infusions | |
| Influence of Infusion Rate on Temporally-Associated AEs | IgPro10 (≤ 4 mg/kg/Min) | All temporally-associated AEs | 23 | Infusions | |
| Influence of Infusion Rate on Temporally-Associated AEs | IgPro10 (≤ 8 mg/kg/Min) | All temporally-associated AEs | 153 | Infusions | |
| Influence of Infusion Rate on Temporally-Associated AEs | IgPro10 (> 8 to ≤ 12 mg/kg/Min) | All temporally-associated AEs | 30 | Infusions | |
| Influence of Infusion Rate on Temporally-Associated AEs | IgPro10 (≤ 4 mg/kg/Min) | Headache | 10 | Infusions | |
| Influence of Infusion Rate on Temporally-Associated AEs | IgPro10 (≤ 8 mg/kg/Min) | Headache | 54 | Infusions | |
| Influence of Infusion Rate on Temporally-Associated AEs | IgPro10 (> 8 to ≤ 12 mg/kg/Min) | Headache | 2 | Infusions | |
| Influence of Infusion Rate on Temporally-Associated AEs | IgPro10 (≤ 4 mg/kg/Min) | Pyrexia | 0 | Infusions |
1 to 10 of 67Source ClinicalTrials.gov
See all 67 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IgPro10 | 55 | |
| Overall Study | COMPLETED | IgPro10 | 43 | |
| Overall Study | NOT COMPLETED | IgPro10 | 12 |
Source ClinicalTrials.gov
Adverse events51
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | IgPro10 | 21 | 55 | 147 |
| other | Sinusitis | Infections and infestations | IgPro10 | 14 | 55 | 15 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | IgPro10 | 12 | 55 | 17 |
| other | Nausea | Gastrointestinal disorders | IgPro10 | 11 | 55 | 16 |
| other | Diarrhea | Gastrointestinal disorders | IgPro10 | 10 | 55 | 13 |
| other | Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | IgPro10 | 9 | 55 | 11 |
| other | Pyrexia | General disorders | IgPro10 | 8 | 55 | 22 |
| other | Vomiting | Gastrointestinal disorders | IgPro10 | 8 | 55 | 12 |
| other | Back pain | Musculoskeletal and connective tissue disorders | IgPro10 | 6 | 55 | 12 |
| other | Eczema | Skin and subcutaneous tissue disorders | IgPro10 | 6 | 55 | 6 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IgPro10 | ||
| Total, other adverse events | IgPro10 | 48 | 55 |
| Total, serious adverse events | IgPro10 | 11 | 55 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20217199 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00322556
GET https://conductscience.org/api/trials/v1/NCT00322556/results?page=2