Trial · NCT03277313
Registered outcomes47
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 47
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate Represented as Mean Number of Acute Serious Bacterial Infections (ASBI) Per Participant-year | From first dose of study drug up to end of Study Epoch 2 (up to approximately 37.2 months) | The rate of ASBI was defined as the mean number of ASBI per participant-year based on the United States (U.S.) Food and drugs Administration (FDA) guidance for industry to support marketing of human immune globulin intravenous (IGIV) as replacement therapy for primary humoral immunodeficiency and the European Medicines Agency (EMA) guideline on the clinical investigation of human normal immunoglobulin for SC and /or intramuscular administration. ASBI included bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess, diagnosed according to the Diagnostic Criteria for Acute Serious Bacterial Infections. |
| Secondary | Rate Represented as Mean Number of All Infections Per Participant-year | From first dose of study drug up to end of Study Epoch 2 (up to approximately 37.2 months) | The rate of all infections was defined as the mean number of all infections per participant-year. Number of all infections was calculated as number of infections per participant-year. |
| Secondary | Epoch 2: Trough Levels of Immunoglobulin G (IgG) Total and IgG Subclasses | Study Epoch 2, Year 1: Months 0, 6, and 12; Year 2: Months 18, 24 and 36 | |
| Secondary | Epoch 2: Trough Levels of Specific Antibodies to Clinically Relevant Pathogens Categorized as Clostridium Tetani Toxoid and Hepatitis B Virus | Study Epoch 2, Year 2: Months 6, 24, and 36 | |
| Secondary | Epoch 2: Trough Levels of Specific Antibodies to Clinically Relevant Pathogen Haemophilus Influenzae B | Study Epoch 2, Year 2: Months 6, 24, and 36 | |
| Secondary | Epoch 2: Area Under the Curve Normalized for Week (AUCweek) | Study Epoch 2, Month 6: Day 0 pre-infusion, and at Days 2, 4, 10, 21 and 28 post-infusion | |
| Secondary | Epoch 2: Area Under the Curve Over the Infusion Interval (AUCTau) | Study Epoch 2, Month 6: Day 0 pre-infusion, and at Days 2, 4, 10, 21 and 28 post-infusion | |
| Secondary | Epoch 2: Apparent Clearance (CL/F) | Study Epoch 2, Month 6: Day 0 pre-infusion, and at Days 2, 4, 10, 21 and 28 post-infusion | |
| Secondary | Epoch 2: Maximum Concentration (Cmax) | Study Epoch 2, Month 6: Day 0 pre-infusion, and at Days 2, 4, 10, 21 and 28 post-infusion | |
| Secondary | Epoch 2: Minimum Concentration (Cmin) | Study Epoch 2, Month 6: Day 0 pre-infusion, and at Days 2, 4, 10, 21 and 28 post-infusion | |
| Secondary | Epoch 2: Time to Maximum Concentration (Tmax) | Study Epoch 2, Month 6: Day 0 pre-infusion, and at Days 2, 4, 10, 21 and 28 post-infusion | |
| Secondary | Epoch 2: Terminal Half-life (T 1/2) | Study Epoch 2, Month 6: Day 0 pre-infusion, and at Days 2, 4, 10, 21 and 28 post-infusion | |
| Secondary | Number of Participants With Serious Adverse Events (SAEs) Excluding Infections, Related and Not Related | From first dose of study drug up to EOS (up to 4 years 9 months) | An SAE is defined as an untoward medical occurrence that at any dose is fatal, life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event. Number of participants who experienced SAEs, related or not related, was reported. |
| Secondary | Rate of SAEs Excluding Infections, Related and Not Related, Per Infusion | From first dose of study drug up to EOS (up to 4 years 9 months) | Rate of SAEs per infusion was calculated as number of serious adverse events/total number of infusions administered to participants in the analysis set. Rate of SAEs per infusion (excluding infections) was reported. |
| Secondary | Number of Participants With All Treatment Emergent Adverse Events (TEAEs) Excluding Infections, Related and Not Related | From first dose of study drug up to EOS (up to 4 years 9 months) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Number of participants who experienced TEAEs, related or not related, was reported. |
| Secondary | Rate of All TEAEs Excluding Infections, Related and Not Related, Per Infusion | From first dose of study drug up to EOS (up to 4 years 9 months) | Rate of all TEAEs per infusion was calculated as number of any adverse reaction events/total number of infusions administered to participants in the analysis set. Rate of any adverse reactions per infusion (excluding infections) was reported. |
| Secondary | Number of Participants With Local TEAEs Excluding Infections, Related and Not Related | From first dose of study drug up to EOS (up to 4 years 9 months) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Number of participants who experienced local TEAEs, related or not related, was reported. |
| Secondary | Rate of Local TEAEs Excluding Infections, Related and Not Related, Per Infusion | From first dose of study drug up to EOS (up to 4 years 9 months) | Rate of local TEAEs per infusion was calculated as number of local TEAEs/total number of infusions administered to participants in the analysis set. Rate of local TEAEs per infusion (excluding infections) was reported. |
| Secondary | Number of Participants With Systemic TEAEs Excluding Infections, Related and Not Related | From first dose of study drug up to EOS (up to 4 years 9 months) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Number of participants who experienced systemic TEAEs, related or not related, was reported. |
| Secondary | Rate of Systemic TEAEs Excluding Infections, Related and Not Related, Per Infusion | From first dose of study drug up to EOS (up to 4 years 9 months) | Rate of systemic TEAEs per infusion was calculated as number of systemic TEAEs/total number of infusions administered to participants in the analysis set. Rate of systemic TEAEs per infusion (excluding infections) was reported. |
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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