Trial · NCT00419341
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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 |
| Secondary | Use of Antibiotics for Infection Prophylaxis and Treatment | Efficacy period: up to 12 months (week 13 to the completion visit) | Annualized rate of days with antibiotics for infection prophylaxis and treatment. The annualized rate was based on the total number of days of antibiotic use for infection prophylaxis and treatment in the efficacy period, and the total number of subject study days for all subjects in the specified analysis population, and adjusted to 365 days. |
| Secondary | Total Serum IgG Trough Levels | Every 4 weeks, throughout the 12-month efficacy period | The IgG trough values per subject were aggregated to a median value, and then median values across subjects were summarized using descriptive statistics. |
| Secondary | Maximum Concentration (Cmax) of Total Serum IgG at Steady State | Week 28 ± 1 week of the treatment period | |
| Secondary | Tmax at Steady State | Week 28 ± 1 week of the treatment period | Timepoint of maximum concentration (Cmax) |
| Other | Minimum Concentration (Cmin) of Total Serum IgG at Steady State | Week 28 ± 1 week of the treatment period | |
| Other | Rate of All AEs by Relatedness and Seriousness | For the duration of the study, up to 15 months | The rate of AEs was the number of AEs over the number of infusions administered. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs. |
| Other | Rate of Mild, Moderate, or Severe Local Reactions | For the duration of the study, up to 15 months | In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of injection site reaction, injection site bruising, infusion site scab, injection site cyst, injection site eczema, injection site irritation, injection site nodule, and injection site pain. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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