Trial · NCT01175213
Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID
NCT01175213, Phase 3, Completed, Baxalta now part of Shire; results first posted 2016-05-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID. Trials, record NCT01175213. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01175213
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID
- NCT number
- NCT01175213
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 66 participants, actual
- Lead sponsor
- Baxalta now part of Shire
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Interventions
- SC treatment with IGSC, 10% with rHuPH20 followed by SC/IGSC, 10% only (safety), SC treatment with IGSC, 10% with rHuPH20 followed by IV/IGSC, 10% only (safety), IV treatment with IGSC, 10%
- First posted
- 2010-08-04
- Last updated
- 2021-05-19
- Results first posted
- 2016-05-26
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annual Rate of Serious Bacterial Infections | Throughout the efficacy period only (from 60 to 729 days) | The point estimate of the annual rate of validated acute serious bacterial infections (VASBIs) per participant per year was provided during subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20). This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20. |
| Primary | Annual Rate of All Infections | Throughout the efficacy period only (from 60 to 729 days) | Annualized rate of infections per participant as defined by MedDRA system organ class (SOC) "infections and infestations". The point estimate of the annual rate of all infections was provided during subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20). This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20. |
| Primary | Trough Levels of IgG Maintained During the Study Period in Relation to Dose Frequency | Throughout the efficacy period only (from 60 to 729 days) | Immunoglobulin (IgG) steady state trough levels were measured in relation to dose frequency by measuring in relation to treatment interval (2-, 3- or 4-week intervals). Initially participants were administered subcutaneous (SC) infusions of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20) \[or IV infusions of IGSC, 10% only\] at the treatment intervals and dose determined by epoch 2 of study 160603 (3- or 4-week intervals). After 3 treatment intervals (either 3- or 4- week intervals), participants changed to a 2-week treatment interval, if agreed with participant and investigator, with the dose adjusted to 1/2 of the 4-week dose or 2/3 of the 3-week dose, whichever was applicable. The rHuPH20 dose was adjusted relative to the new IGSC, 10% dose in order to achieve a dose ratio of 75 U/g IgG. This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20. |
| Secondary | The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Separated into age groups as described below and into related (related to either study drug) and not related (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution (IGSC), 10% and recombinant human hyaluronidase (rHuPH20). |
| Secondary | Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for AEs | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | |
| Secondary | Percentage of Infusions Associated With One or More Moderate or Severe AEs (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of an Infusion | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | |
| Secondary | Number of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20 | Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months) | Participants who develop binding antibodies and/or neutralizing antibodies to recombinant human hyaluronidase (rHuPH20) from study 160603 and/ or from this study (160902) are included here. This study (160902) is an extension of study 160603. Study 160603 was divided into 2 study epochs. In epoch 1 of study 160603 participants were treated with intravenous (IV) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%. In epoch 2 of study 160603 participants were treated with subcutaneous (SC) administration of IGSC, 10% after SC administration of rHuPH20. Only participants who completed study 160603 were eligible to be screened and enrolled in this study (160902). In this study, participants started on same doses of IGSC, 10% and rHuPH20 that were used for the last infusions in epoch 2 of study 160603. |
| Secondary | Percentage of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20 | Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months) | Participants who develop binding antibodies and/or neutralizing antibodies to recombinant human hyaluronidase (rHuPH20) from study 160603 and/ or from this study (160902) are included here. This study (160902) is an extension of study 160603. Study 160603 was divided into 2 study epochs. In epoch 1 of study 160603 participants were treated with intravenous (IV) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%. In epoch 2 of study 160603 participants were treated with subcutaneous (SC) administration of IGSC, 10% after SC administration of rHuPH20. Only participants who completed study 160603 were eligible to be screened and enrolled in this study (160902). In this study, participants started on same doses of IGSC, 10% and rHuPH20 that were used for the last infusions in epoch 2 of study 160603. |
| Secondary | Number of Participants With AEs Related to Anti-rHuPH20 Titers | Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months) | |
| Secondary | Percentage of Participants With AEs Related to Anti-rHuPH20 Titers | Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months) |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annual Rate of Serious Bacterial Infections | Throughout the efficacy period only (from 60 to 729 days) | Safety Analysis Set excluding the 3 participants who were treated with intravenous (IV) administration of IGSC, 10% without rHuPH20 | Estimated infections/year | NUMBER |
| PRIMARY | Annual Rate of All Infections | Throughout the efficacy period only (from 60 to 729 days) | Safety Analysis Set excluding the 3 participants who were treated with intravenous (IV) administration of IGSC, 10% without rHuPH20 | Number of infections/year | NUMBER |
| PRIMARY | Trough Levels of IgG Maintained During the Study Period in Relation to Dose Frequency | Throughout the efficacy period only (from 60 to 729 days) | Safety Analysis Set | g/L | MEDIAN |
| SECONDARY | The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Safety Analysis Set | SAEs/year | NUMBER |
| SECONDARY | Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for AEs | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Safety Analysis Set | Percentage of infusions | NUMBER |
| SECONDARY | Percentage of Infusions Associated With One or More Moderate or Severe AEs (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of an Infusion | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Safety Analysis Set | Percentage of infusions | NUMBER |
| SECONDARY | Number of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20 | Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months) | Participants from study 160603 and this study (160902) who have received at least one infusion of rHuPH20 | Number of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20 | Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months) | Participants from study 160603 and this study (160902) who have received at least one infusion of rHuPH20 | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With AEs Related to Anti-rHuPH20 Titers | Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months) | All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902. | Number of participants | NUMBER |
| SECONDARY | Percentage of Participants With AEs Related to Anti-rHuPH20 Titers | Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months) | All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902. | Percentage of participants | NUMBER |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group3,255
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Annual Rate of Serious Bacterial Infections | All Participants Treated With IGSC, 10% and rHuPH20 | 0.020 | Estimated infections/year | ||
| Annual Rate of All Infections | All Participants Treated With IGSC, 10% and rHuPH20 | 2.86 | 95% Confidence Interval 2.36 to 3.43 | Number of infections/year | |
| Trough Levels of IgG Maintained During the Study Period in Relation to Dose Frequency | All Participants Treated With rHuPH20 and/or IGSC, 10% | 2-Week Treatment Interval [N=17] | 10.900 | 95% Confidence Interval 9.390 to 13.300 | g/L |
| Trough Levels of IgG Maintained During the Study Period in Relation to Dose Frequency | All Participants Treated With rHuPH20 and/or IGSC, 10% | 3-Week Treatment Interval [N=9] | 12.300 | 95% Confidence Interval 11.500 to 15.300 | g/L |
| Trough Levels of IgG Maintained During the Study Period in Relation to Dose Frequency | All Participants Treated With rHuPH20 and/or IGSC, 10% | 4-Week Treatment Interval [N=47] | 9.760 | 95% Confidence Interval 9.260 to 10.700 | g/L |
| The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | IGSC, 10% - rHuPH20 | Participants aged 2 to <12 years - not related | 0.0000 | SAEs/year | |
| The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Participants aged 2 to <12 years - not related | 0.0000 | SAEs/year | |
| The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | IGSC, 10% - rHuPH20 | Participants aged 2 to <12 years - related | 0.0000 | SAEs/year | |
| The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Participants aged 2 to <12 years - related | 0.0000 | SAEs/year | |
| The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | IGSC, 10% - rHuPH20 | Participants aged 12 to <16 years - not related | 0.0768 | SAEs/year |
1 to 10 of 3,255Source ClinicalTrials.gov
See all 3,255 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| IGSC, 10%/rHuPH20 | STARTED | IGSC - rHuPH20 Then IGSC, 10% or IGIV, 10% Only | 63 | |
| IGSC, 10%/rHuPH20 | STARTED | IGIV, 10% Only | 3 | |
| IGSC, 10%/rHuPH20 | COMPLETED | IGSC - rHuPH20 Then IGSC, 10% or IGIV, 10% Only | 48 | |
| IGSC, 10%/rHuPH20 | COMPLETED | IGIV, 10% Only | 3 | |
| IGSC, 10%/rHuPH20 | NOT COMPLETED | IGSC - rHuPH20 Then IGSC, 10% or IGIV, 10% Only | 15 | |
| IGSC, 10%/rHuPH20 | NOT COMPLETED | IGIV, 10% Only | 0 | |
| Safety Follow-up | STARTED | IGSC - rHuPH20 Then IGSC, 10% or IGIV, 10% Only | 48 | |
| Safety Follow-up | STARTED | IGIV, 10% Only | 3 | |
| Safety Follow-up | COMPLETED | IGSC - rHuPH20 Then IGSC, 10% or IGIV, 10% Only | 47 | |
| Safety Follow-up | COMPLETED | IGIV, 10% Only | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events142
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 | Lymphadenopathy | Blood and lymphatic system disorders | IGSC, 10% - rHuPH20 | 5 | 63 | 5 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Safety Follow-up - IGSC, 10% or IGIV, 10% Only | 1 | 51 | 2 |
| other | Tachycardia | Cardiac disorders | IGSC, 10% - rHuPH20 | 5 | 63 | 6 |
| other | Tachycardia | Cardiac disorders | Safety Follow-up - IGSC, 10% or IGIV, 10% Only | 1 | 51 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | IGSC, 10% - rHuPH20 | 4 | 63 | 7 |
| other | Abdominal Pain | Gastrointestinal disorders | Safety Follow-up - IGSC, 10% or IGIV, 10% Only | 2 | 51 | 4 |
| other | Abdominal Pain Upper | Gastrointestinal disorders | IGSC, 10% - rHuPH20 | 7 | 63 | 8 |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Safety Follow-up - IGSC, 10% or IGIV, 10% Only | 0 | 51 | 0 |
| other | Apthous Stomatitis | Gastrointestinal disorders | IGSC, 10% - rHuPH20 | 4 | 63 | 7 |
| other | Apthous Stomatitis | Gastrointestinal disorders | Safety Follow-up - IGSC, 10% or IGIV, 10% Only | 2 | 51 | 2 |
1 to 10 of 142Source ClinicalTrials.gov
See all 142 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IGSC, 10% - rHuPH20 | ||
| Total, all-cause mortality | Safety Follow-up - IGSC, 10% or IGIV, 10% Only | ||
| Total, other adverse events | IGSC, 10% - rHuPH20 | 60 | 63 |
| Total, other adverse events | Safety Follow-up - IGSC, 10% or IGIV, 10% Only | 45 | 51 |
| Total, serious adverse events | IGSC, 10% - rHuPH20 | 9 | 63 |
| Total, serious adverse events | Safety Follow-up - IGSC, 10% or IGIV, 10% Only | 3 | 51 |
Source ClinicalTrials.gov
Papers2
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| IGSC, 10% - rHuPH20 vs Safety Follow-up - IGSC, 10% or IGIV, 10% Only: serious adverse events |
Source Trial comparisons
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/NCT01175213
GET https://conductscience.org/api/trials/v1/NCT01175213/registered?page=2