Trial · NCT03277313
Outcomes47
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 47
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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) | FAS included all participants who provided informed consent, and met enrollment eligibility. | ASBI per participant-year | MEAN |
| 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) | FAS included all participants who provided informed consent, and met enrollment eligibility. | infections per participant-year | MEAN |
| 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 | FAS=all participants who provided informed consent, and met enrollment eligibility. Only FAS participants in Epoch 2 were analyzed for this outcome measure. Overall number analyzed=number of participants with data available for analyses. Number analyzed=number of participants with data available for analysis at specified timepoint. | grams per liter (g/L) | MEAN |
| 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 | FAS=all participants who provided informed consent, and met enrollment eligibility. Only FAS participants in Epoch 2 were analyzed for this outcome measure. Overall number analyzed=number of participants with data available for analyses. Number analyzed=number of participants with data available for analysis at specified timepoint. | international unit per milliliter(IU/mL) | MEAN |
| 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 | FAS=all participants who provided informed consent, and met enrollment eligibility. Only FAS participants in Epoch 2 were analyzed for this outcome measure. Overall number analyzed=number of participants with data available for analyses. Number analyzed=number of participants with data available for analysis at specified timepoint. | milligrams per liter (mg/L) | MEAN |
| 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 | Pharmacokinetic analysis set (PKAS) included all participants in the Safety Analysis Set who have at least 1 evaluable post-dose concentration data for PK assessments without major protocol deviations or events affecting the PK results. Overall number analyzed is the number of participants with data available for analyses. As pre-specified in statistical analysis plan (SAP), this outcome measure was planned only for Epoch 2. | grams*day per liter (g*day/L) | GEOMETRIC_MEAN |
| 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 | PKAS included all participants in the Safety Analysis Set who have at least 1 evaluable post-dose concentration data for PK assessments without major protocol deviations or events affecting the PK results. Overall number analyzed is the number of participants with data available for analyses. As pre-specified in SAP, this outcome measure was planned only for Epoch 2. | g*day/L | GEOMETRIC_MEAN |
| 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 | PKAS included all participants in the Safety Analysis Set who have at least 1 evaluable post-dose concentration data for PK assessments without major protocol deviations or events affecting the PK results. Overall number analyzed is the number of participants with data available for analyses. As pre-specified in SAP, this outcome measure was planned only for Epoch 2. | milliliters per day (mL/day) | GEOMETRIC_MEAN |
| 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 | PKAS included all participants in the Safety Analysis Set who have at least 1 evaluable post-dose concentration data for PK assessments without major protocol deviations or events affecting the PK results. Overall number analyzed is the number of participants with data available for analyses. As pre-specified in SAP, this outcome measure was planned only for Epoch 2. | g/L | GEOMETRIC_MEAN |
| 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 | PKAS included all participants in the Safety Analysis Set who have at least 1 evaluable post-dose concentration data for PK assessments without major protocol deviations or events affecting the PK results. Overall number analyzed is the number of participants with data available for analyses. As pre-specified in SAP, this outcome measure was planned only for Epoch 2. | g/L | GEOMETRIC_MEAN |
| 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 | PKAS included all participants in the Safety Analysis Set who have at least 1 evaluable post-dose concentration data for PK assessments without major protocol deviations or events affecting the PK results. Overall number analyzed is the number of participants with data available for analyses. As pre-specified in SAP, this outcome measure was planned only for Epoch 2. | days | MEDIAN |
| 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 | PKAS included all participants in the Safety Analysis Set who have at least 1 evaluable post-dose concentration data for PK assessments without major protocol deviations or events affecting the PK results. Overall number analyzed is the number of participants with data available for analyses. As pre-specified in SAP, this outcome measure was planned only for Epoch 2. | days | GEOMETRIC_MEAN |
| 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) | Safety Analysis Set (SAS) included all participants who received at least one dose of HyQvia. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | SAS included all participants who received at least one dose of HyQvia. | SAEs per infusion | NUMBER |
| 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) | SAS included all participants who received at least one dose of HyQvia. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | SAS included all participants who received at least one dose of HyQvia. | adverse reaction event per infusion | NUMBER |
| 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) | SAS included all participants who received at least one dose of HyQvia. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | SAS included all participants who received at least one dose of HyQvia. | local TEAEs per infusion | NUMBER |
| 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) | SAS included all participants who received at least one dose of HyQvia. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | SAS included all participants who received at least one dose of HyQvia. | systemic TEAEs per infusion | NUMBER |
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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