Trial · NCT00278954
Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases.
NCT00278954, Phase 3, Completed, Bio Products Laboratory; results first posted 2010-01-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases. Trials, record NCT00278954. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00278954
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases.
- NCT number
- NCT00278954
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 50 participants, actual
- Lead sponsor
- Bio Products Laboratory
- Conditions
- Primary Immunodeficiency, Common Variable Hypogammaglobulinemia, X-linked Hypogammaglobulinemia, Hypogammaglobulinemia, Immunodeficiency With Hyper-IgM, Wiskott-Aldrich Syndrome
- Interventions
- Gammaplex (Intravenous immunoglobulin)
- First posted
- 2006-01-19
- Last updated
- 2013-01-24
- Results first posted
- 2010-01-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Serious, Acute, Bacterial Infections (SABIs) Per Subject Per Year in Subjects With Primary Immunodeficiency Disease. | 12 months | By assessing the number of serious, acute, bacterial infections per subject per year in subjects with Primary Immunodeficiency disease. |
| Secondary | The Pharmacokinetic (PK) Half-Life of Immunoglobulin G (IgG) | -5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days | Blood samples for PK analysis were obtained and analysed at 10 different time points, i.e. -5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days, at an infusion visit following 6 months of treatment. |
| Secondary | The Pharmacokinetic (PK) Clearance of Immunoglobulin G (IgG) | -5, 0, 60 min, 24, 48 hrs, 4, 7, 14, 21 and 28 days | Blood samples for PK analysis were obtained and analysed at 10 different time points, i.e. -5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days, at an infusion visit following 6 months of treatment. |
| Secondary | The Pharmacokinetic (PK) Volume of Distribution (Vz)of Immunoglobulin G (IgG) | -5, 0, 60 min, 24, 48 hrs, 4, 7, 14, 21 and 28 days | Blood samples for PK analysis were obtained and analysed at 10 different time points, i.e. -5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days, at an infusion visit following 6 months of treatment. |
| Secondary | The Pharmacokinetic (PK) Mean Residence Time (MRT) for Inmuunoglobulin G (IgG) | -5, 0, 60 min, 24, 48 hrs, 4, 7, 14, 21 and 28 days | Blood samples for PK analysis were obtained and analysed at 10 different time points, i.e. -5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days, at an infusion visit following 6 months of treatment. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Serious, Acute, Bacterial Infections (SABIs) Per Subject Per Year in Subjects With Primary Immunodeficiency Disease. | 12 months | Intent to Treat (ITT). | SABIs/subject/year | NUMBER |
| SECONDARY | The Pharmacokinetic (PK) Half-Life of Immunoglobulin G (IgG) | -5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days | Only 24 of the 45 evaluable subjects participated in the Pharmacokinetic part of the protocol. No data imputation. | Days | MEAN |
| SECONDARY | The Pharmacokinetic (PK) Clearance of Immunoglobulin G (IgG) | -5, 0, 60 min, 24, 48 hrs, 4, 7, 14, 21 and 28 days | Only 24 of the 45 evaluable subjects participated in the Pharmacokinetic part of the protocol. No data imputation. | mL/day/kg | MEAN |
| SECONDARY | The Pharmacokinetic (PK) Volume of Distribution (Vz)of Immunoglobulin G (IgG) | -5, 0, 60 min, 24, 48 hrs, 4, 7, 14, 21 and 28 days | Only 24 of the 45 evaluable subjects participated in the Pharmacokinetic part of the protocol. No data imputation. | dL/kg | MEAN |
| SECONDARY | The Pharmacokinetic (PK) Mean Residence Time (MRT) for Inmuunoglobulin G (IgG) | -5, 0, 60 min, 24, 48 hrs, 4, 7, 14, 21 and 28 days | Days | MEAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Serious, Acute, Bacterial Infections (SABIs) Per Subject Per Year in Subjects With Primary Immunodeficiency Disease. | Gammaplex | 0 | SABIs/subject/year | ||
| The Pharmacokinetic (PK) Half-Life of Immunoglobulin G (IgG) | Gammaplex | 41.19 | Standard Deviation 19.19 | Days | |
| The Pharmacokinetic (PK) Clearance of Immunoglobulin G (IgG) | Gammaplex | 0.585 | Standard Deviation 0.2508 | mL/day/kg | |
| The Pharmacokinetic (PK) Volume of Distribution (Vz)of Immunoglobulin G (IgG) | Gammaplex | 0.297 | Standard Deviation 0.0539 | dL/kg | |
| The Pharmacokinetic (PK) Mean Residence Time (MRT) for Inmuunoglobulin G (IgG) | Gammaplex | 56.1 | Standard Deviation 23.06 | Days |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gammaplex | 50 | |
| Overall Study | COMPLETED | Gammaplex | 45 | |
| Overall Study | NOT COMPLETED | Gammaplex | 5 |
Source ClinicalTrials.gov
Adverse events43
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 | Asthma | Respiratory, thoracic and mediastinal disorders | Gammaplex | 4 | 50 | 19 |
| other | Athralgia | Musculoskeletal and connective tissue disorders | Gammaplex | 3 | 50 | 5 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Gammaplex | 5 | 50 | 6 |
| other | Bronchitis | Infections and infestations | Gammaplex | 6 | 50 | 7 |
| other | Bronchitis acute | Infections and infestations | Gammaplex | 4 | 50 | 5 |
| other | Chest pain | General disorders | Gammaplex | 3 | 50 | 3 |
| other | Chills | General disorders | Gammaplex | 4 | 50 | 7 |
| other | Conjunctivitis | Eye disorders | Gammaplex | 4 | 50 | 5 |
| other | Contusion | Injury, poisoning and procedural complications | Gammaplex | 3 | 50 | 3 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Gammaplex | 3 | 50 | 5 |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gammaplex | ||
| Total, other adverse events | Gammaplex | 47 | 50 |
| Total, serious adverse events | Gammaplex | 6 | 50 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36818468 | 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 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/NCT00278954
GET https://conductscience.org/api/trials/v1/NCT00278954/events?page=2