Trial · NCT01485796
Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD
NCT01485796, Phase 2, Phase 3, Completed, Baxalta now part of Shire; results first posted 2017-04-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD. Trials, record NCT01485796. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01485796
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD
- NCT number
- NCT01485796
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 54 participants, actual
- Lead sponsor
- Baxalta now part of Shire
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Interventions
- Immune Globulin Infusion (Human), 10%, Recombinant human hyaluronidase
- First posted
- 2011-12-06
- Last updated
- 2021-05-19
- Results first posted
- 2017-04-24
- Limitations and caveats
Treatment with rHuPH20 was stopped as of August 2012 following discussion with the FDA. 26 subjects still active in Study Epoch 2 went into a safety follow-up period and were treated with IGI, 10% (GAMMAGARD LIQUID) intravenously or subcutaneously.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Related Systemic Adverse Events (Excluding Infections) | 7 months (per subject) | |
| Primary | Rate of Related Systemic Adverse Events (Excluding Infections) Per Infusion | 7 months (per subject) | A point estimate and 95% confidence interval for the rate of related systemic adverse events per infusion was derived using a Poisson model. |
| Secondary | Proportion of Subjects Who Achieve a Treatment Interval of 3 or 4 Weeks in Epoch 2 | 6 months (per subject) | |
| Secondary | Proportion of Subjects Who Maintain a Treatment Interval of 3 or 4 Weeks in Epoch 2 for 24 Weeks | 6 months (per subject) | |
| Secondary | Number of Related Local Adverse Events (Excluding Infections) | 7 months (per subject) | |
| Secondary | Rate of Related Local Adverse Events (Excluding Infections) Per Infusion | 7 months (per subject) | A point estimate and 95% confidence interval for the rate of related local adverse events per infusion was derived using a Poisson model. |
| Secondary | Number of All Related Adverse Events (Excluding Infections) | 7 months (per subject) | |
| Secondary | Rate of All Adverse Events (Excluding Infections) Per Infusion | 7 months (per subject) | A point estimate and 95% confidence interval for the rate of adverse events per infusion was derived using a Poisson model. |
| Secondary | Number of Subjects Who Develop Neutralizing Antibodies to rHuPH20 | 7 months (per subject) | |
| Secondary | Trough Levels of Immunoglobulin G (IgG) | 7 months (per subject) | IgG trough levels at the beginning of Study Epoch 1 (previous immunoglobulin treatment) and at the end of Study Epoch 2 were analyzed. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Related Systemic Adverse Events (Excluding Infections) | 7 months (per subject) | adverse events | NUMBER | |
| PRIMARY | Rate of Related Systemic Adverse Events (Excluding Infections) Per Infusion | 7 months (per subject) | adverse events | NUMBER | |
| SECONDARY | Proportion of Subjects Who Achieve a Treatment Interval of 3 or 4 Weeks in Epoch 2 | 6 months (per subject) | subjects | NUMBER | |
| SECONDARY | Proportion of Subjects Who Maintain a Treatment Interval of 3 or 4 Weeks in Epoch 2 for 24 Weeks | 6 months (per subject) | subjects | NUMBER | |
| SECONDARY | Number of Related Local Adverse Events (Excluding Infections) | 7 months (per subject) | adverse events | NUMBER | |
| SECONDARY | Rate of Related Local Adverse Events (Excluding Infections) Per Infusion | 7 months (per subject) | adverse events | NUMBER | |
| SECONDARY | Number of All Related Adverse Events (Excluding Infections) | 7 months (per subject) | adverse events | NUMBER | |
| SECONDARY | Rate of All Adverse Events (Excluding Infections) Per Infusion | 7 months (per subject) | adverse events | NUMBER | |
| SECONDARY | Number of Subjects Who Develop Neutralizing Antibodies to rHuPH20 | 7 months (per subject) | subjects | NUMBER | |
| SECONDARY | Trough Levels of Immunoglobulin G (IgG) | 7 months (per subject) | At screening, data (ie, IgG trough levels) were available for analysis from 36 participants. At the end of Epoch 2, data were available for analysis from only 33 participants. | g/L | GEOMETRIC_MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Related Systemic Adverse Events (Excluding Infections) | Safety Analysis Set (n=37) | 59 | adverse events | ||
| Rate of Related Systemic Adverse Events (Excluding Infections) Per Infusion | Safety Analysis Set (n=37) | Epoch 1 | 0.250 | 95% Confidence Interval 0.140 to 0.406 | adverse events |
| Rate of Related Systemic Adverse Events (Excluding Infections) Per Infusion | Epoch 2 Data Set (n=36) | Epoch 1 | 0.253 | 95% Confidence Interval 0.141 to 0.413 | adverse events |
| Rate of Related Systemic Adverse Events (Excluding Infections) Per Infusion | Safety Analysis Set (n=37) | Epoch 2 | 0.377 | 95% Confidence Interval 0.205 to 0.626 | adverse events |
| Rate of Related Systemic Adverse Events (Excluding Infections) Per Infusion | Epoch 2 Data Set (n=36) | Epoch 2 | 0.377 | 95% Confidence Interval 0.205 to 0.626 | adverse events |
| Rate of Related Systemic Adverse Events (Excluding Infections) Per Infusion | Safety Analysis Set (n=37) | Epoch 1+2 | 0.324 | 95% Confidence Interval 0.187 to 0.517 | adverse events |
| Rate of Related Systemic Adverse Events (Excluding Infections) Per Infusion | Epoch 2 Data Set (n=36) | Epoch 1+2 | 0.326 | 95% Confidence Interval 0.186 to 0.522 | adverse events |
| Proportion of Subjects Who Achieve a Treatment Interval of 3 or 4 Weeks in Epoch 2 | Epoch 2 Data Set (n=36) | 3 or 4-week treatment interval | 36 | subjects | |
| Proportion of Subjects Who Achieve a Treatment Interval of 3 or 4 Weeks in Epoch 2 | Epoch 2 Data Set (n=36) | 3-week treatment interval | 6 | subjects | |
| Proportion of Subjects Who Achieve a Treatment Interval of 3 or 4 Weeks in Epoch 2 | Epoch 2 Data Set (n=36) | 4-week treatment interval | 30 | subjects |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1: Epoch 1 (Ramp-up) | STARTED | Subcutaneous Treatment With IGI, 10% and rHuPH20 | 37 | |
| Period 1: Epoch 1 (Ramp-up) | Treated in Epoch 1 | Subcutaneous Treatment With IGI, 10% and rHuPH20 | 37 | |
| Period 1: Epoch 1 (Ramp-up) | COMPLETED | Subcutaneous Treatment With IGI, 10% and rHuPH20 | 36 | |
| Period 1: Epoch 1 (Ramp-up) | NOT COMPLETED | Subcutaneous Treatment With IGI, 10% and rHuPH20 | 1 | |
| Period 2: Epoch 2 | STARTED | Subcutaneous Treatment With IGI, 10% and rHuPH20 | 36 | |
| Period 2: Epoch 2 | Treated in Epoch 2 | Subcutaneous Treatment With IGI, 10% and rHuPH20 | 36 | |
| Period 2: Epoch 2 | COMPLETED | Subcutaneous Treatment With IGI, 10% and rHuPH20 | 1 | |
| Period 2: Epoch 2 | NOT COMPLETED | Subcutaneous Treatment With IGI, 10% and rHuPH20 | 35 | |
| Overall Trial (Incl. Safety Follow-up) | STARTED | Subcutaneous Treatment With IGI, 10% and rHuPH20 | 37 | |
| Overall Trial (Incl. Safety Follow-up) | Treated in Epoch 1 (Ramp-up) | Subcutaneous Treatment With IGI, 10% and rHuPH20 | 37 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events68
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 | Upper abdominal pain | Gastrointestinal disorders | Epochs 1+2 (SC Treatment w/ IGI,10% and rHuPH20, n=37) | 2 | 37 | 2 |
| other | Upper abdominal pain | Gastrointestinal disorders | Safety Follow-up (n=26) | 0 | 26 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Epochs 1+2 (SC Treatment w/ IGI,10% and rHuPH20, n=37) | 3 | 37 | 3 |
| other | Diarrhea | Gastrointestinal disorders | Safety Follow-up (n=26) | 0 | 26 | 0 |
| other | Nausea | Gastrointestinal disorders | Epochs 1+2 (SC Treatment w/ IGI,10% and rHuPH20, n=37) | 5 | 37 | 10 |
| other | Nausea | Gastrointestinal disorders | Safety Follow-up (n=26) | 1 | 26 | 2 |
| other | Vomiting | Gastrointestinal disorders | Epochs 1+2 (SC Treatment w/ IGI,10% and rHuPH20, n=37) | 2 | 37 | 2 |
| other | Vomiting | Gastrointestinal disorders | Safety Follow-up (n=26) | 0 | 26 | 0 |
| other | Fatigue | General disorders | Epochs 1+2 (SC Treatment w/ IGI,10% and rHuPH20, n=37) | 6 | 37 | 6 |
| other | Fatigue | General disorders | Safety Follow-up (n=26) | 0 | 26 | 0 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Epochs 1+2 (SC Treatment w/ IGI,10% and rHuPH20, n=37) | ||
| Total, all-cause mortality | Safety Follow-up (n=26) | ||
| Total, other adverse events | Epochs 1+2 (SC Treatment w/ IGI,10% and rHuPH20, n=37) | 30 | 37 |
| Total, other adverse events | Safety Follow-up (n=26) | 10 | 26 |
| Total, serious adverse events | Epochs 1+2 (SC Treatment w/ IGI,10% and rHuPH20, n=37) | 0 | 37 |
| Total, serious adverse events | Safety Follow-up (n=26) | 1 | 26 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|
| Epochs 1+2 (SC Treatment w/ IGI,10% and rHuPH20, n=37) vs Safety Follow-up (n=26): 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/NCT01485796
GET https://conductscience.org/api/trials/v1/NCT01485796/results?page=2