Trial · NCT00419341
Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy
NCT00419341, Phase 3, Completed, CSL Behring; results first posted 2013-01-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy. Trials, record NCT00419341. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00419341
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy
- NCT number
- NCT00419341
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 49 participants, actual
- Lead sponsor
- CSL Behring
- Conditions
- Primary Immune Deficiency
- Interventions
- Human Normal Immunoglobulin for Subcutaneous Administration
- First posted
- 2007-01-08
- Last updated
- 2013-01-25
- Results first posted
- 2013-01-25
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) (MITT Population) | Efficacy period: up to 12 months (week 13 to the completion visit) | The annualized rate was based on the total number of SBIs and the total number of subject study days during the efficacy period for all subjects in the specified analysis population and adjusted to 365 days. Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an adverse event (AE) was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined criteria for SBIs. |
| Primary | Area Under the Concentration-time Curve (AUC) of Total Serum Immunoglobulin G (IgG) | Measured during a single dosing interval after at least 12 weeks of stable subcutaneous (SC) dosing with IgPro20 treatment | Evaluate non-inferiority of steady-state IgG area under the concentration-time curves standardized to a 7-day period (sAUCs) for subcutaneous immunoglobulin (SCIG) (IgPro20) versus the sAUC under intravenous immunoglobulin (IVIG) (Privigen) treatment. The sAUC under IVIG was taken from the same subjects in a preceding study (either ZLB03\_002CR \[NCT00168025\] or ZLB05\_006CR \[NCT00322556\]). |
| Secondary | Annualized Rate of Clinically Documented SBIs (ITT Population) | For the duration of the study, up to 15 months | The annualized rate was based on the total number of SBIs and the total number of subject study days during the study for all subjects in the specified analysis population and adjusted to 365 days. Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an AE was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined criteria for SBIs. |
| Secondary | Annualized Rate of Clinically Documented SBIs (PPE Population) | Efficacy period: up to 12 months (week 13 to the completion visit) | The annualized rate was based on the total number of SBIs and the total number of subject study days during the efficacy period for all subjects in the specified analysis population and adjusted to 365 days. Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an AE was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined criteria for SBIs. |
| Secondary | Annualized Rate of Infection Episodes | Efficacy period: up to 12 months (week 13 to completion visit) | The annualized rate was based on the total number of infection episodes occurring during the efficacy period (N = 96) divided by the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. |
| Secondary | Number of Infection Episodes (Serious and Non-serious) | Efficacy period: up to 12 months (week 13 to the completion visit) | Total number of infections for the specified analysis population |
| Secondary | Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections | Efficacy period: up to 12 months (week 13 to the completion visit) | The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection (N = 71), and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. |
| Secondary | Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections | Efficacy period: up to 12 months (week 13 to the completion visit) | Total number of days out of work / school / kindergarten / day care or unable to perform normal daily activities due to infections, for the specified analysis population |
| Secondary | Annualized Rate of Hospitalization Due to Infection | Efficacy period: up to 12 months (week 13 to the completion visit) | The annualized rate was based on the total number of days of hospitalization due to infection (N = 7) and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. |
| Secondary | Number of Days of Hospitalization Due to Infections | Efficacy period: up to 12 months (week 13 to the completion visit) | Total number of days of hospitalization due to infections for the specified analysis population |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) (MITT Population) | Efficacy period: up to 12 months (week 13 to the completion visit) | The modified intention-to-treat (MITT) population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 13) who had the disease under study. | SBIs per subject year | NUMBER |
| PRIMARY | Area Under the Concentration-time Curve (AUC) of Total Serum Immunoglobulin G (IgG) | Measured during a single dosing interval after at least 12 weeks of stable subcutaneous (SC) dosing with IgPro20 treatment | The Per Protocol Pharmacokinetic (PPK) population included all subjects with the disease under study who fulfilled the requirements of the PK substudy, including PK sampling in a preceding study with IVIG (Privigen, CSL Behring), and fulfilling IgPro20 dosing requirements and providing adequate PK blood samples in the current study. | days*g/L | MEAN |
| SECONDARY | Annualized Rate of Clinically Documented SBIs (ITT Population) | For the duration of the study, up to 15 months | The Intention To Treat (ITT) population included all subjects who were treated with IgPro20 during any study period. | SBIs per subject year | NUMBER |
| SECONDARY | Annualized Rate of Clinically Documented SBIs (PPE Population) | Efficacy period: up to 12 months (week 13 to the completion visit) | The Per Protocol Efficacy (PPE) population included all subjects who completed the 12-month efficacy period according to the protocol-defined requirements. | SBIs per subject year | NUMBER |
| SECONDARY | Annualized Rate of Infection Episodes | Efficacy period: up to 12 months (week 13 to completion visit) | The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 13) who had the disease under study. | infection episodes per subject year | NUMBER |
| SECONDARY | Number of Infection Episodes (Serious and Non-serious) | Efficacy period: up to 12 months (week 13 to the completion visit) | The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study. | infections | NUMBER |
| SECONDARY | Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections | Efficacy period: up to 12 months (week 13 to the completion visit) | The modified intention-to-treat (MITT) population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 13) who had the disease under study. | days per subject year | NUMBER |
| SECONDARY | Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections | Efficacy period: up to 12 months (week 13 to the completion visit) | The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study. | days | NUMBER |
| SECONDARY | Annualized Rate of Hospitalization Due to Infection | Efficacy period: up to 12 months (week 13 to the completion visit) | The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study. | days per subject year | NUMBER |
| SECONDARY | Number of Days of Hospitalization Due to Infections | Efficacy period: up to 12 months (week 13 to the completion visit) | The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study. | days | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) (MITT Population) | IgPro20 | 0.00 | SBIs per subject year | ||
| Area Under the Concentration-time Curve (AUC) of Total Serum Immunoglobulin G (IgG) | IgPro20 (PK Substudy) | 105.6 | Standard Deviation 31.56 | days*g/L | |
| Area Under the Concentration-time Curve (AUC) of Total Serum Immunoglobulin G (IgG) | IVIG (Privigen; Previous Study) | 103.2 | Standard Deviation 20.00 | days*g/L | |
| Annualized Rate of Clinically Documented SBIs (ITT Population) | IgPro20 | 0.00 | SBIs per subject year | ||
| Annualized Rate of Clinically Documented SBIs (PPE Population) | IgPro20 | 0.00 | SBIs per subject year | ||
| Annualized Rate of Infection Episodes | IgPro20 | 2.76 | 95% Confidence Interval 2.235 to 3.370 | infection episodes per subject year | |
| Number of Infection Episodes (Serious and Non-serious) | IgPro20 | 96 | infections | ||
| Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections | IgPro20 | 2.06 | days per subject year | ||
| Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections | IgPro20 | 71 | days | ||
| Annualized Rate of Hospitalization Due to Infection | IgPro20 | 0.20 | 0 to 7 | days per subject year |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Wash in/Wash Out Period | STARTED | IgPro20 | 49 | |
| Wash in/Wash Out Period | COMPLETED | IgPro20 | 38 | |
| Wash in/Wash Out Period | NOT COMPLETED | IgPro20 | 11 | |
| Efficacy Period | STARTED | IgPro20 | 38 | |
| Efficacy Period | COMPLETED | IgPro20 | 28 | |
| Efficacy Period | NOT COMPLETED | IgPro20 | 10 |
Source ClinicalTrials.gov
Adverse events41
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 | Injection site reaction | General disorders | IgPro20 | 49 | 49 | 1,314 |
| other | Sinusitis | Infections and infestations | IgPro20 | 14 | 49 | 20 |
| other | Headache | Nervous system disorders | IgPro20 | 13 | 49 | 40 |
| other | Nasopharyngitis | Infections and infestations | IgPro20 | 11 | 49 | 15 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | IgPro20 | 8 | 49 | 9 |
| other | Diarrhoea | Gastrointestinal disorders | IgPro20 | 7 | 49 | 8 |
| other | Bronchitis | Infections and infestations | IgPro20 | 6 | 49 | 9 |
| other | Fatigue | General disorders | IgPro20 | 6 | 49 | 6 |
| other | Abdominal pain upper | Gastrointestinal disorders | IgPro20 | 5 | 49 | 5 |
| other | Acute sinusitis | Infections and infestations | IgPro20 | 5 | 49 | 7 |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IgPro20 | ||
| Total, other adverse events | IgPro20 | 49 | 49 |
| Total, serious adverse events | IgPro20 | 7 | 49 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT00419341
GET https://conductscience.org/api/trials/v1/NCT00419341/results?page=2