Trial · NCT03116347
Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects
NCT03116347, Phase 4, Completed, Baxalta now part of Shire; results first posted 2023-01-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects. Trials, record NCT03116347. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03116347
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects
- NCT number
- NCT03116347
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 42 participants, actual
- Lead sponsor
- Baxalta now part of Shire
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Interventions
- HYQVIA, KIOVIG, Cuvitru
- First posted
- 2017-04-17
- Last updated
- 2023-01-11
- Other registries' IDs
- eudract:2016-003438-26
- Results first posted
- 2023-01-11
Source ClinicalTrials.gov
Registered outcomes41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety: Number of Participants With Any Severe Related Treatment-emergent Adverse Events (TEAEs) Per Infusion (Excluding Infections) | From start of study drug administration up to 20 months | An Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered an investigational product (IP) that does not necessarily have a causal relationship with the treatment. TEAEs were the AEs with onset after date-time of first dose of IP, or any medical condition present prior to the start of IP but increased in severity or relationship after date-time of first dose of IP. TEAEs that were recorded as "possibly related" or "probably related" to HYQVIA were considered HYQVIA-related adverse events. Number of participants with any severe related TEAEs (excluding infections) was reported. |
| Primary | Safety: Rate of Any Severe Related TEAEs Per Infusion (Excluding Infections) | From start of study drug administration up to 20 months | An AE was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. TEAEs were the AEs with onset after date-time of first dose of IP, or any medical condition present prior to the start of IP but increased in severity or relationship after date-time of first dose of IP. TEAEs that were recorded as "possibly related" or "probably related" to HYQVIA were considered HYQVIA-related adverse events. Severe related TEAEs rate per infusion was calculated as number of severe related TEAEs/total number of infusions administered to participants in the analysis set. Rate of any severe related TEAEs per infusion (excluding infections) was reported. |
| Primary | Safety: Number of Participants With Any Related Serious TEAEs Per Infusion (Excluding Infections) | From start of study drug administration up to 20 months | TEAEs were the AEs with onset after date-time of first dose of IP, or any medical condition present prior to the start of IP but increased in severity or relationship after date-time of first dose of IP. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs that were recorded as "possibly related" or "probably related" to HYQVIA were considered HYQVIA-related adverse events. Number of participants with any related serious TEAEs per infusion (excluding infections) was reported. |
| Primary | Safety: Rate of Any Related Serious TEAEs Per Infusion (Excluding Infections) | From start of study drug administration up to 20 months | TEAEs were the AEs with onset after date-time of first dose of IP, or any medical condition present prior to the start of IP but increased in severity or relationship after date-time of first dose of IP. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in-patient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs that were recorded as "possibly related" or "probably related" to HYQVIA were considered HYQVIA-related adverse events. Rate of related serious TEAEs per infusion was calculated as number of related serious TEAEs/total number of infusions administered to participants in the analysis set. Rate of any related serious TEAEs per Infusion (excluding infections) was reported. |
| Secondary | Efficacy: Change From Baseline in Total Serum Trough Levels of Immunoglobulin G (IgG) at Month 12 | Baseline, Month 12 | Change from baseline in total serum trough levels of IgG in Epoch 1 and 2 was reported. Baseline was defined as the last non-missing value before the initial dose of HYQVIA. |
| Secondary | Efficacy: Change From Baseline in Serum Trough Levels of IgG Subclasses at Month 12 | Baseline, Month 12 | Change from baseline in Serum trough levels of IgG subclasses 1, 2, 3, and 4 in Epoch 1 and 2 was reported. Baseline was defined as the last non-missing value before the initial dose of HYQVIA. |
| Secondary | Efficacy: Change From Baseline in Trough Levels of Specific Antibodies to Clostridium Tetani Toxoid IgG at Month 12 | Baseline, Month 12 | Change from baseline in trough levels of specific antibodies in clostridium tetani toxoid IgG at Month 12 was reported. Baseline was defined as the last non-missing value before the initial dose of HYQVIA. Here, IU/ml was defined as "International units per milliliter". |
| Secondary | Efficacy: Change From Baseline in Trough Levels of Specific Antibodies to Hepatitis B Virus (HBV) at Month 12 | Baseline, Month 12 | Change from baseline in trough levels of specific antibodies in HBV at Month 12 was reported. Baseline was defined as the last non-missing value before the initial dose of HYQVIA. |
| Secondary | Efficacy: Change From Baseline in Trough Levels of Specific Antibodies to Haemophilus Influenzae B IgG at Month 12 | Baseline, Month 12 | Change from baseline in trough levels of specific antibodies in Haemophilus influenzae B IgG at Month 12 was reported. Baseline was defined as the last non-missing value before the initial dose of HYQVIA. |
| Secondary | Safety: Percentage of Participants Who Achieved a Treatment Interval of Three or Four Weeks in Epoch 2 | Up to 20 months | Percentage of participants who achieved a treatment interval of three or four weeks in Epoch 2 was reported. |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 registered outcomesOutcomes41
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety: Number of Participants With Any Severe Related Treatment-emergent Adverse Events (TEAEs) Per Infusion (Excluding Infections) | From start of study drug administration up to 20 months | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Safety: Rate of Any Severe Related TEAEs Per Infusion (Excluding Infections) | From start of study drug administration up to 20 months | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Number of Severe Related TEAEs/Infusion | NUMBER |
| PRIMARY | Safety: Number of Participants With Any Related Serious TEAEs Per Infusion (Excluding Infections) | From start of study drug administration up to 20 months | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Safety: Rate of Any Related Serious TEAEs Per Infusion (Excluding Infections) | From start of study drug administration up to 20 months | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Number of Related Serious TEAEs/Infusion | NUMBER |
| SECONDARY | Efficacy: Change From Baseline in Total Serum Trough Levels of Immunoglobulin G (IgG) at Month 12 | Baseline, Month 12 | Full analysis set included all participants who provide informed consent and meet enrollment eligibility. Here, Overall number of Participants Analyzed signifies participants who were evaluable for this outcome measure. | Gram per liter (g/L) | MEAN |
| SECONDARY | Efficacy: Change From Baseline in Serum Trough Levels of IgG Subclasses at Month 12 | Baseline, Month 12 | All participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. Here, Overall number of Participants Analyzed signifies participants who were evaluable for this outcome measure. | g/L | MEAN |
| SECONDARY | Efficacy: Change From Baseline in Trough Levels of Specific Antibodies to Clostridium Tetani Toxoid IgG at Month 12 | Baseline, Month 12 | All participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. Here, Overall number of Participants Analyzed signifies participants who were evaluable for this outcome measure. Specific antibody data were not scheduled to be collected at Epoch 2 Month 0, so for most participants baseline could not be defined and change from baseline was not reported in HYQVIA Pre-treated arm. | IU/ml | MEAN |
| SECONDARY | Efficacy: Change From Baseline in Trough Levels of Specific Antibodies to Hepatitis B Virus (HBV) at Month 12 | Baseline, Month 12 | All participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. Here, Overall number of Participants Analyzed signifies participants who were evaluable for this outcome measure. Specific antibody data were not scheduled to be collected at Epoch 2 Month 0, so for most participants baseline could not be defined and change from baseline was not reported in HYQVIA Pre-treated arm. | International units per liter (IU/L) | MEAN |
| SECONDARY | Efficacy: Change From Baseline in Trough Levels of Specific Antibodies to Haemophilus Influenzae B IgG at Month 12 | Baseline, Month 12 | All participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. Here, Overall number of Participants Analyzed signifies participants who were evaluable for this outcome measure. Specific antibody data were not scheduled to be collected at Epoch 2 Month 0, so for most participants baseline could not be defined and change from baseline was not reported in HYQVIA Pre-treated arm. | Milligram per liter (mg/L) | MEAN |
| SECONDARY | Safety: Percentage of Participants Who Achieved a Treatment Interval of Three or Four Weeks in Epoch 2 | Up to 20 months | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Percentage of participants | NUMBER |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 outcomesResults by group116
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety: Number of Participants With Any Severe Related Treatment-emergent Adverse Events (TEAEs) Per Infusion (Excluding Infections) | HyQvia New Starters | 1 | Participants | ||
| Safety: Number of Participants With Any Severe Related Treatment-emergent Adverse Events (TEAEs) Per Infusion (Excluding Infections) | HyQvia Pre-treated | 0 | Participants | ||
| Safety: Rate of Any Severe Related TEAEs Per Infusion (Excluding Infections) | HyQvia New Starters | 0.004 | Number of Severe Related TEAEs/Infusion | ||
| Safety: Rate of Any Severe Related TEAEs Per Infusion (Excluding Infections) | HyQvia Pre-treated | 0 | Number of Severe Related TEAEs/Infusion | ||
| Safety: Number of Participants With Any Related Serious TEAEs Per Infusion (Excluding Infections) | HyQvia New Starters | 0 | Participants | ||
| Safety: Number of Participants With Any Related Serious TEAEs Per Infusion (Excluding Infections) | HyQvia Pre-treated | 0 | Participants | ||
| Safety: Rate of Any Related Serious TEAEs Per Infusion (Excluding Infections) | HyQvia New Starters | 0 | Number of Related Serious TEAEs/Infusion | ||
| Safety: Rate of Any Related Serious TEAEs Per Infusion (Excluding Infections) | HyQvia Pre-treated | 0 | Number of Related Serious TEAEs/Infusion | ||
| Efficacy: Change From Baseline in Total Serum Trough Levels of Immunoglobulin G (IgG) at Month 12 | HyQvia New Starters | 0.035 | Standard Deviation 1.6983 | Gram per liter (g/L) | |
| Efficacy: Change From Baseline in Total Serum Trough Levels of Immunoglobulin G (IgG) at Month 12 | HyQvia Pre-treated | -0.709 | Standard Deviation 2.6576 | Gram per liter (g/L) |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HyQvia New Starters | 23 | |
| Overall Study | STARTED | HyQvia Pre-treated | 19 | |
| Overall Study | Started Epoch 1 | HyQvia New Starters | 23 | |
| Overall Study | Started Epoch 1 | HyQvia Pre-treated | 0 | |
| Overall Study | Completed Epoch 1 | HyQvia New Starters | 22 | |
| Overall Study | Completed Epoch 1 | HyQvia Pre-treated | 0 | |
| Overall Study | Started Epoch 2 | HyQvia New Starters | 22 | |
| Overall Study | Started Epoch 2 | HyQvia Pre-treated | 19 | |
| Overall Study | Completed Epoch 2 | HyQvia New Starters | 22 | |
| Overall Study | Completed Epoch 2 | HyQvia Pre-treated | 17 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events98
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 | Neutropenia | Blood and lymphatic system disorders | HyQvia New Starters | 0 | 23 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | HyQvia Pre-treated | 1 | 19 | 1 |
| other | Conjunctival haemorrhage | Eye disorders | HyQvia New Starters | 0 | 23 | 0 |
| other | Conjunctival haemorrhage | Eye disorders | HyQvia Pre-treated | 1 | 19 | 1 |
| other | Eye pain | Eye disorders | HyQvia New Starters | 1 | 23 | 1 |
| other | Eye pain | Eye disorders | HyQvia Pre-treated | 1 | 19 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | HyQvia New Starters | 1 | 23 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | HyQvia Pre-treated | 1 | 19 | 5 |
| other | Inflammatory bowel disease | Gastrointestinal disorders | HyQvia New Starters | 0 | 23 | 0 |
| other | Inflammatory bowel disease | Gastrointestinal disorders | HyQvia Pre-treated | 1 | 19 | 1 |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HyQvia New Starters | 0 | 23 |
| Total, all-cause mortality | HyQvia Pre-treated | 0 | 19 |
| Total, other adverse events | HyQvia New Starters | 22 | 23 |
| Total, other adverse events | HyQvia Pre-treated | 14 | 19 |
| Total, serious adverse events | HyQvia New Starters | 2 | 23 |
| Total, serious adverse events | HyQvia Pre-treated | 5 | 19 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39289739 | DERIVED |
Source PubMed
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 comparisons13
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| HyQvia New Starters vs HyQvia Pre-treated: Safety: Number of Participants With Local TEAEs (Excluding Infections) | Trial comparisons |
| HyQvia New Starters vs HyQvia Pre-treated: Safety: Number of Participants With Any Related Serious TEAEs Per Infusion (Excluding Infections) | Trial comparisons |
| HyQvia New Starters vs HyQvia Pre-treated: Safety: Number of Participants With Any Severe Related Treatment-emergent Adverse Events (TEAEs) Per Infusion (Excluding Infections) | Trial comparisons |
| HyQvia New Starters vs HyQvia Pre-treated: Safety: Number of Participants With Any Adverse Reactions (Excluding Infections) | Trial comparisons |
| HyQvia New Starters vs HyQvia Pre-treated: Safety: Number of Participants With Any TEAEs (Excluding Infections) | Trial comparisons |
| HyQvia New Starters vs HyQvia Pre-treated: Safety: Number of Participants With Any Related (Causally) and/or Temporally Associated TEAEs (Excluding Infections) | Trial comparisons |
| HyQvia New Starters vs HyQvia Pre-treated: Safety: Number of Participants With Local Adverse Reaction (Excluding Infections) | Trial comparisons |
| HyQvia New Starters vs HyQvia Pre-treated: Safety: Number of Participants With Any Serious TEAEs (Excluding Infections) | Trial comparisons |
| HyQvia New Starters vs HyQvia Pre-treated: Safety: Number of Participants With Any Temporally Associated TEAEs (Excluding Infections) | Trial comparisons |
| HyQvia New Starters vs HyQvia Pre-treated: Safety: Number of Participants With Systemic TEAEs (Excluding Infections) | Trial comparisons |
1 to 10 of 13
See all 13 trial comparisonsTests0
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.
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