Trial · NCT00814320
Gammagard Liquid and rHuPH20 in PID
NCT00814320, Phase 3, Completed, Baxalta now part of Shire; results first posted 2015-12-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Gammagard Liquid and rHuPH20 in PID. Trials, record NCT00814320. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00814320
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gammagard Liquid and rHuPH20 in PID
- NCT number
- NCT00814320
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 89 participants, actual
- Lead sponsor
- Baxalta now part of Shire
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Interventions
- Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV), Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV)
- First posted
- 2008-12-24
- Last updated
- 2021-05-19
- Results first posted
- 2015-12-03
Source ClinicalTrials.gov
Registered outcomes66
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Validated Acute Serious Bacterial Infection (VASBI) Rate | Throughout the study period (17 months) | Serious acute bacterial infections include bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess that are caused by a recognized bacterial pathogen. VASBI rate is the mean number of VASBIs per participant per year, recorded for SC Administration of IGIV, 10%, with rHuPH20 after ramp-up, only. The mean number of VASBIs per participant per year and the 99% upper confidence limit for the acute serious bacterial infection rate were calculated using a Poisson model to account for the length of the observation periods per participant. |
| Secondary | Bioavailability (AUC) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants ≥12 Years | PK AUC evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion | Bioavailability expressed as pharmacokinetic (PK) equivalence of immunoglobulin (IgG) in terms of ratio of Area Under the Concentration Curve (AUC)/Week after administration of immune globulin intravenous (IGIV), 10% given via subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up to intravenous (IV) route, i.e. ratio of AUC/week of SC/rHuPH20 versus IV administration of IGIV, 10%. Expressed as a percentage. |
| Secondary | Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants Aged 2 to < 12 Years | IgG trough levels measured at baseline and on day of each 3- or 4-week infusion for infusion for IV and SC (except during ramp-up for SC) and at end of study visit | Bioavailability expressed as pharmacokinetic (PK) equivalence of immunoglobulin (IgG) in terms of trough levels after administration of immune globulin intravenous (IGIV), 10% given via subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up to intravenous (IV) route, i.e. ratio of AUC/week of SC/rHuPH20 versus IV administration of IGIV, 10%. Expressed as a percentage. |
| Secondary | Bioavailability (AUC) of IgG After SC Administration of IGIV, 10%, Given With and Without rHuPH20 | PK: 160603 (IV: before infusion (inf.) #4 [3-week treatment interval] or inf. #3 [4-week treatment interval];SC: before last SC inf.) 1 hour pre-inf. ≤28 days (+/-2 days) post-inf.; 160601- 1 hour pre-inf. (before inf. #8) ≤7 days (+/-1 day) post-inf. | Bioavailability of immunoglobulin (IgG) after subcutaneous (SC) administration of immune globulin intravenous (IGIV), 10%, with and without recombinant human hyaluronidase (rHuPH20) (from current study 160603 and study 160601, respectively), as measured by ratio of AUC of IgG per dose/kg with versus without rHuPH20. Expressed as a percentage. This was analysed for participants in Stratum A , participants in Stratum B and for all participants who received IGIV, 10% via SC administration (Stratum A plus Stratum B): Stratum A: Participants who provided data both on SC with AND without rHuPH20 ie, participants who participated in both studies 160601 and 160603; Stratum B: Participants who provided data on SC with OR without rHuPH20, but not on both (participants who participated in study 160601 OR 160603, but not in both studies). |
| Secondary | Annual Rate of All Infections Per Participant | Throughout the study period (17 months) | Annual rate of all infections per participant after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the annual rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary endpoint. |
| Secondary | Trough Levels of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | IgG trough levels measured at baseline and on day of each 3- or 4-week infusion for IV and SC (except during ramp up for SC) and at end of study visit. | Trough levels of immunoglobulin (IgG) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up |
| Secondary | Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | IgG subclasses (1-4) trough levels measured at baseline and on day of each 3- or 4-week infusion for infusion for IV and SC (except during ramp up for SC) and at end of study visit | Trough levels of immunoglobulin (IgG) subclasses after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up by IgG subclasses 1 to 4 at end of IV treatment and end of SC treatment with rHuPH20 IgG subclass 1 (IgG 1) IgG subclass 2 (IgG 2) IgG subclass 3 (IgG 3) IgG subclass 4 (IgG 4) |
| Secondary | Antibody Levels to Tetanus (Clostridium Tetani Toxoid) | IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit | Antibody levels to Tetanus (Clostridium tetani toxoid) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20 |
| Secondary | Antibody Levels to Haemophilus Influenzae | IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit | Antibody levels to Haemophilus influenzae after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20 |
| Secondary | Antibody Levels to Measles | IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit | Antibody levels to measles after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 registered outcomesOutcomes66
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Validated Acute Serious Bacterial Infection (VASBI) Rate | Throughout the study period (17 months) | Estimated infections/year | NUMBER | |
| SECONDARY | Bioavailability (AUC) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants ≥12 Years | PK AUC evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion | Participants ≥ 12 years exposed to either or both study drugs with AUC measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\* SC- Days 1, 3, 5, 9, 14, 21, 28\* \*Measurements at Day 28 for the 4-week treatment interval only | Percentage | NUMBER |
| SECONDARY | Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants Aged 2 to < 12 Years | IgG trough levels measured at baseline and on day of each 3- or 4-week infusion for infusion for IV and SC (except during ramp-up for SC) and at end of study visit | Participants aged 2 to \< 12 years exposed to either or both study drugs with available IgG trough level measurements | Percentage | NUMBER |
| SECONDARY | Bioavailability (AUC) of IgG After SC Administration of IGIV, 10%, Given With and Without rHuPH20 | PK: 160603 (IV: before infusion (inf.) #4 [3-week treatment interval] or inf. #3 [4-week treatment interval];SC: before last SC inf.) 1 hour pre-inf. ≤28 days (+/-2 days) post-inf.; 160601- 1 hour pre-inf. (before inf. #8) ≤7 days (+/-1 day) post-inf. | Participants in the Full Analysis Data Set aged ≥ 12 years from the current study (160603) and prior Baxter study 160601 who received IGIV, 10% via SC administration | Percentage | NUMBER |
| SECONDARY | Annual Rate of All Infections Per Participant | Throughout the study period (17 months) | Full Analysis Data Set | Estimated infections/year | NUMBER |
| SECONDARY | Trough Levels of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | IgG trough levels measured at baseline and on day of each 3- or 4-week infusion for IV and SC (except during ramp up for SC) and at end of study visit. | Full Analysis Data Set | g/L | MEDIAN |
| SECONDARY | Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | IgG subclasses (1-4) trough levels measured at baseline and on day of each 3- or 4-week infusion for infusion for IV and SC (except during ramp up for SC) and at end of study visit | Participants who have been exposed to either or both study drugs with available IgG subclass trough level measurements | mg/dL | MEDIAN |
| SECONDARY | Antibody Levels to Tetanus (Clostridium Tetani Toxoid) | IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit | Participants in Full Analysis Data Set with available specific antibody test results | IU/mL | MEDIAN |
| SECONDARY | Antibody Levels to Haemophilus Influenzae | IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit | Participants in Full Analysis Data Set with available specific antibody test results | μg/mL | MEDIAN |
| SECONDARY | Antibody Levels to Measles | IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit | Participants in the Full Analysis Data Set with available specific antibody test results | Titer | MEDIAN |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 outcomesResults by group3,540
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Validated Acute Serious Bacterial Infection (VASBI) Rate | Full Analysis Data Set (FADS) | 0.025 | Estimated infections/year | ||
| Bioavailability (AUC) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants ≥12 Years | % Ratio IgG AUC/Week of SC/ IV | 93.3 | 90% Confidence Interval 91.4 to 95.2 | Percentage | |
| Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants Aged 2 to < 12 Years | %Ratio IgG Trough Level of SC/IV | 103.8 | 95% Confidence Interval 97.5 to 115.4 | Percentage | |
| Bioavailability (AUC) of IgG After SC Administration of IGIV, 10%, Given With and Without rHuPH20 | Ratio IgG AUC of SC With and Without rHuPH20 | Participants in Stratum A (N=19) | 118.7 | 90% Confidence Interval 113.6 to 124.1 | Percentage |
| Bioavailability (AUC) of IgG After SC Administration of IGIV, 10%, Given With and Without rHuPH20 | Ratio IgG AUC of SC With and Without rHuPH20 | Participants in Stratum B (N=54) | 133.6 | 90% Confidence Interval 118.3 to 150.8 | Percentage |
| Bioavailability (AUC) of IgG After SC Administration of IGIV, 10%, Given With and Without rHuPH20 | Ratio IgG AUC of SC With and Without rHuPH20 | Total Participants (N=73) | 120.4 | 90% Confidence Interval 115.5 to 125.5 | Percentage |
| Annual Rate of All Infections Per Participant | IV Administration of IGIV, 10% | 4.51 | 95% Confidence Interval 3.50 to 5.69 | Estimated infections/year | |
| Annual Rate of All Infections Per Participant | SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | 2.97 | 95% Confidence Interval 2.51 to 3.47 | Estimated infections/year | |
| Trough Levels of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | Participants Aged 2 to <12 Years | end of IV part | 9.63 | 95% Confidence Interval 8.29 to 13.60 | g/L |
| Trough Levels of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | Participants ≥12 Years | end of IV part | 10.40 | 95% Confidence Interval 9.63 to 11.4 | g/L |
1 to 10 of 3,540Source ClinicalTrials.gov
See all 3,540 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Epoch 1 (IV Treatment) | STARTED | 2 to <12 Years | 14 | |
| Epoch 1 (IV Treatment) | STARTED | 12 Years and Older | 73 | |
| Epoch 1 (IV Treatment) | COMPLETED | 2 to <12 Years | 13 | |
| Epoch 1 (IV Treatment) | COMPLETED | 12 Years and Older | 71 | |
| Epoch 1 (IV Treatment) | NOT COMPLETED | 2 to <12 Years | 1 | |
| Epoch 1 (IV Treatment) | NOT COMPLETED | 12 Years and Older | 2 | |
| Between Epoch 1 (IV) and Epoch 2 Ramp-up | STARTED | 2 to <12 Years | 13 | |
| Between Epoch 1 (IV) and Epoch 2 Ramp-up | STARTED | 12 Years and Older | 71 | |
| Between Epoch 1 (IV) and Epoch 2 Ramp-up | COMPLETED | 2 to <12 Years | 13 | |
| Between Epoch 1 (IV) and Epoch 2 Ramp-up | COMPLETED | 12 Years and Older | 70 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events130
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 | IV Administration of IGIV, 10% | 2 | 87 | 2 |
| other | LYMPHADENOPATHY | Blood and lymphatic system disorders | SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up) | 7 | 83 | 9 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | IV Administration of IGIV, 10% | 1 | 87 | 1 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up) | 7 | 83 | 10 |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | IV Administration of IGIV, 10% | 3 | 87 | 3 |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up) | 6 | 83 | 11 |
| other | DIARRHOEA | Gastrointestinal disorders | IV Administration of IGIV, 10% | 7 | 87 | 7 |
| other | DIARRHOEA | Gastrointestinal disorders | SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up) | 10 | 83 | 15 |
| other | NAUSEA | Gastrointestinal disorders | IV Administration of IGIV, 10% | 12 | 87 | 13 |
| other | NAUSEA | Gastrointestinal disorders | SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up) | 15 | 83 | 28 |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IV Administration of IGIV, 10% | ||
| Total, all-cause mortality | SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up) | ||
| Total, other adverse events | IV Administration of IGIV, 10% | 67 | 87 |
| Total, other adverse events | SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up) | 81 | 83 |
| Total, serious adverse events | IV Administration of IGIV, 10% | 3 | 87 |
| Total, serious adverse events | SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up) | 12 | 83 |
Source ClinicalTrials.gov
Papers3
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 |
|---|
| IV Administration of IGIV, 10% vs SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up): 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.
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Read this trial from software.
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