Trial · NCT03033745
Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary Immunodeficiency (PID)
NCT03033745, Phase 4, Completed, CSL Behring; results first posted 2020-01-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary Immunodeficiency (PID). Trials, record NCT03033745. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03033745
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary Immunodeficiency (PID)
- NCT number
- NCT03033745
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 49 participants, actual
- Lead sponsor
- CSL Behring
- Conditions
- Primary Immunodeficiency
- Interventions
- IgPro20
- First posted
- 2017-01-27
- Last updated
- 2020-03-25
- Other registries' IDs
- eudract:2016-003799-33
- Results first posted
- 2020-01-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Responders | At the end of 4 weeks for each planned infusion parameter | A responder is a subject within the Pump-Assisted Cohorts that performs at least 3 out of 4 valid infusions at a certain infusion parameter level (weekly volumes per injection site of 25-50 mL; weekly flow rates per injection site of 25-100 mL/hour). Determination of a responder in the Manual Push Cohort is more complex due to the expected variable frequency of infusions per week (ie, 5-17) for different subjects. A responder within the Manual Push Cohort is a subject that performs a minimum number of valid infusions during 4 weeks corresponding to a certain flow rate level (\[ie, 2-7 times per week\], flow rates per injection site of 30-120 mL/hour). Valid infusions do not need to be consecutive, but each subject needs to adhere to the same schedule (number of infusions per week) throughout the study. An infusion parameter will be considered successful if at least one third (≥ 33%) of the subjects in the corresponding cohort are responders at that infusion parameter level. |
| Secondary | Rate of Treatment-emergent Adverse Events (TEAEs) Per Infusion | At the end of 4 weeks for each planned infusion parameter | Adverse event rate per infusion = number of adverse events/total number of infusions prior to subject's start date of non-response. Only events are included which start prior to subject's start date of non-response. |
| Secondary | Rate of Local TEAEs Per Infusion | At the end of 4 weeks for each planned infusion parameter | Local adverse event rate per infusion = number of local adverse events/total number of infusions prior to subject's start date of non-response. Local Adverse Events: comprises all events reported within the MedDRA high level terms "administration site reactions NEC (Not Elsewhere Classified)", "infusion site reactions", and "injection site reactions". Only events are included which start prior to subject's start date of non-response. |
| Secondary | Time to Onset of Local TEAEs | At the end of 4 weeks for each planned infusion parameter | Local Adverse Events: comprises all events reported within the MedDRA high level terms "administration site reactions NEC", "infusion site reactions", and "injection site reactions". Only events are included which start prior to subject's start date of non-response. |
| Secondary | Intensity of Local TEAEs | At the end of 4 weeks for each planned infusion parameter | Mild = A type of AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate = A type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the subject. Severe = A type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Only events are included which start prior to subject's start date of non-response. |
| Secondary | Duration of Local TEAEs | At the end of 4 weeks for each planned infusion parameter | Local Adverse Events: comprises all events reported within the MedDRA high level terms "administration site reactions NEC", "infusion site reactions", and "injection site reactions". |
| Secondary | Tolerability of Infusions | At the end of 4 weeks for each planned infusion parameter | Tolerability = number of infusions without severe local adverse events / total number of infusions. Severe = A type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Only events are included which start prior to subject's start date of non-response. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Responders | At the end of 4 weeks for each planned infusion parameter | The Safety Analysis Set (SAS) comprised all subjects in the Full Analysis Set who received ≥ 1 dose or a partial dose of IgPro20 in the study. | percentage of responders | NUMBER |
| SECONDARY | Rate of Treatment-emergent Adverse Events (TEAEs) Per Infusion | At the end of 4 weeks for each planned infusion parameter | SAS | Number of TEAEs/infusion | NUMBER |
| SECONDARY | Rate of Local TEAEs Per Infusion | At the end of 4 weeks for each planned infusion parameter | SAS | Number of local TEAEs/infusion | NUMBER |
| SECONDARY | Time to Onset of Local TEAEs | At the end of 4 weeks for each planned infusion parameter | SAS | Days | MEAN |
| SECONDARY | Intensity of Local TEAEs | At the end of 4 weeks for each planned infusion parameter | SAS | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Local TEAEs | At the end of 4 weeks for each planned infusion parameter | SAS | Days | MEAN |
| SECONDARY | Tolerability of Infusions | At the end of 4 weeks for each planned infusion parameter | SAS | Ratio | NUMBER |
Source ClinicalTrials.gov
Results by group88
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Responders | IgPro20 (Pump-Assisted Volume Cohort) | 25 ml | 86.7 | percentage of responders | |
| Percentage of Responders | IgPro20 (Pump-Assisted Volume Cohort) | 40 ml | 73.3 | percentage of responders | |
| Percentage of Responders | IgPro20 (Pump-Assisted Volume Cohort) | 50 ml | 73.3 | percentage of responders | |
| Percentage of Responders | IgPro20 (Pump Assisted Flow Rate Cohort) | 25 ml/h | 77.8 | percentage of responders | |
| Percentage of Responders | IgPro20 (Pump Assisted Flow Rate Cohort) | 50 ml/h | 77.8 | percentage of responders | |
| Percentage of Responders | IgPro20 (Pump Assisted Flow Rate Cohort) | 75 ml/h | 66.7 | percentage of responders | |
| Percentage of Responders | IgPro20 (Pump Assisted Flow Rate Cohort) | 100 ml/h | 61.1 | percentage of responders | |
| Percentage of Responders | IgPro20 (Manual Push Flow Rate Cohort) | 30 ml/h | 100.0 | percentage of responders | |
| Percentage of Responders | IgPro20 (Manual Push Flow Rate Cohort) | 60 ml/h | 100.0 | percentage of responders | |
| Percentage of Responders | IgPro20 (Manual Push Flow Rate Cohort) | 120 ml/h | 87.5 | percentage of responders |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IgPro20 (Pump-Assisted Volume Cohort) | 15 | |
| Overall Study | STARTED | IgPro20 (Pump Assisted Flow Rate Cohort) | 18 | |
| Overall Study | STARTED | IgPro20 (Manual Push Flow Rate Cohort) | 16 | |
| Overall Study | COMPLETED | IgPro20 (Pump-Assisted Volume Cohort) | 14 | |
| Overall Study | COMPLETED | IgPro20 (Pump Assisted Flow Rate Cohort) | 17 | |
| Overall Study | COMPLETED | IgPro20 (Manual Push Flow Rate Cohort) | 14 | |
| Overall Study | NOT COMPLETED | IgPro20 (Pump-Assisted Volume Cohort) | 1 | |
| Overall Study | NOT COMPLETED | IgPro20 (Pump Assisted Flow Rate Cohort) | 1 | |
| Overall Study | NOT COMPLETED | IgPro20 (Manual Push Flow Rate Cohort) | 2 |
Source ClinicalTrials.gov
Adverse events470
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 | Hot flush | Vascular disorders | IgPro20 (Pump-assisted Volume) 25 mL | 0 | 15 | 0 |
| other | Hot flush | Vascular disorders | IgPro20 (Pump-assisted Volume) 40 mL | 1 | 12 | 1 |
| other | Hot flush | Vascular disorders | IgPro20 (Pump-assisted Volume) 50 mL | 0 | 11 | 0 |
| other | Hot flush | Vascular disorders | IgPro20 (Pump-assisted Flow Rate) 25 mL/h | 0 | 18 | 0 |
| other | Hot flush | Vascular disorders | IgPro20 (Pump-assisted Flow Rate) 50 mL/h | 0 | 14 | 0 |
| other | Hot flush | Vascular disorders | IgPro20 (Pump-assisted Flow Rate) 75 mL/h | 0 | 13 | 0 |
| other | Hot flush | Vascular disorders | IgPro20 (Pump-assisted Flow Rate) 100 mL/h | 0 | 12 | 0 |
| other | Hot flush | Vascular disorders | IgPro20 (Manual Push Flow Rate) 30 mL/h | 0 | 16 | 0 |
| other | Hot flush | Vascular disorders | IgPro20 (Manual Push Flow Rate) 60 mL/h | 0 | 16 | 0 |
| other | Hot flush | Vascular disorders | IgPro20 (Manual Push Flow Rate) 120 mL/h | 0 | 14 | 0 |
1 to 10 of 470Source ClinicalTrials.gov
See all 470 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IgPro20 (Pump-assisted Volume) 25 mL | 0 | 15 |
| Total, all-cause mortality | IgPro20 (Pump-assisted Volume) 40 mL | 0 | 12 |
| Total, all-cause mortality | IgPro20 (Pump-assisted Volume) 50 mL | 0 | 11 |
| Total, all-cause mortality | IgPro20 (Pump-assisted Flow Rate) 25 mL/h | 0 | 18 |
| Total, all-cause mortality | IgPro20 (Pump-assisted Flow Rate) 50 mL/h | 0 | 14 |
| Total, all-cause mortality | IgPro20 (Pump-assisted Flow Rate) 75 mL/h | 0 | 13 |
| Total, all-cause mortality | IgPro20 (Pump-assisted Flow Rate) 100 mL/h | 0 | 12 |
| Total, all-cause mortality | IgPro20 (Manual Push Flow Rate) 30 mL/h | 0 | 16 |
| Total, all-cause mortality | IgPro20 (Manual Push Flow Rate) 60 mL/h | 0 | 16 |
| Total, all-cause mortality | IgPro20 (Manual Push Flow Rate) 120 mL/h | 0 | 14 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers2
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/NCT03033745
GET https://conductscience.org/api/trials/v1/NCT03033745/results?page=2