Trial · NCT01963143

Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases

NCT01963143, Phase 3, Completed, Bio Products Laboratory; results first posted 2017-03-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases. Trials, record NCT01963143. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01963143

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases
NCT number: NCT01963143
Status: Completed
Phases: Phase 3
Enrollment: 48 participants, actual
Lead sponsor: Bio Products Laboratory
Conditions: Primary Immune Deficiency Disorders, Common Variable Immunodeficiency, X-linked Agammaglobulinaemia, Hyper-IgM Syndrome
Interventions: Gammaplex (5%), Gammaplex 10
First posted: 2013-10-16
Last updated: 2017-03-29
Results first posted: 2017-03-29

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame
Primary	Primary Bioequivalence Analysis - Area Under the Curve Within a 28-day Dosing Interval (AUC0-28) in Adult Subjects	After a minimum 5 infusions on each product, at pre-infusion, 10 minutes before end of infusion, 1, 3, 6, 24, 48 hours, 4, 7, 14, 21 and 28 days post-infusion
Secondary	Secondary Bioequivalence Analysis - Area Under the Curve Within a 21-Day Dosing Interval (AUC0-21) in Adult Subjects	After a minimum 5 infusions on each product, at pre-infusion, 10 minutes before end of infusion, 1, 3, 6, 24, 48 hours, 4, 7, 14 and 21 days post-infusion
Secondary	Secondary Bioequivalence Analysis - IgG Trough Levels	After a minimum 5 infusions on each product, at pre-infusion.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Primary Bioequivalence Analysis - Area Under the Curve Within a 28-day Dosing Interval (AUC0-28) in Adult Subjects	After a minimum 5 infusions on each product, at pre-infusion, 10 minutes before end of infusion, 1, 3, 6, 24, 48 hours, 4, 7, 14, 21 and 28 days post-infusion	PK population	ratio Gammaplex 10%/Gammaplex 5%	GEOMETRIC_MEAN
SECONDARY	Secondary Bioequivalence Analysis - Area Under the Curve Within a 21-Day Dosing Interval (AUC0-21) in Adult Subjects	After a minimum 5 infusions on each product, at pre-infusion, 10 minutes before end of infusion, 1, 3, 6, 24, 48 hours, 4, 7, 14 and 21 days post-infusion		ratio Gammaplex 10%/Gammaplex 5%	GEOMETRIC_MEAN
SECONDARY	Secondary Bioequivalence Analysis - IgG Trough Levels	After a minimum 5 infusions on each product, at pre-infusion.		ratio Gammaplex 10%/Gammaplex 5%	GEOMETRIC_MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Primary Bioequivalence Analysis - Area Under the Curve Within a 28-day Dosing Interval (AUC0-28) in Adult Subjects	Gammaplex 10%	AUC(0-t) absolute	1.01	90% Confidence Interval 0.98 to 1.03	ratio Gammaplex 10%/Gammaplex 5%
Primary Bioequivalence Analysis - Area Under the Curve Within a 28-day Dosing Interval (AUC0-28) in Adult Subjects	Gammaplex 5%	AUC(0-t) absolute	1.01	90% Confidence Interval 0.98 to 1.03	ratio Gammaplex 10%/Gammaplex 5%
Primary Bioequivalence Analysis - Area Under the Curve Within a 28-day Dosing Interval (AUC0-28) in Adult Subjects	Gammaplex 10%	AUC(0-t) baseline-adjusted	1.07	90% Confidence Interval 0.93 to 1.23	ratio Gammaplex 10%/Gammaplex 5%
Primary Bioequivalence Analysis - Area Under the Curve Within a 28-day Dosing Interval (AUC0-28) in Adult Subjects	Gammaplex 5%	AUC(0-t) baseline-adjusted	1.07	90% Confidence Interval 0.93 to 1.23	ratio Gammaplex 10%/Gammaplex 5%
Secondary Bioequivalence Analysis - Area Under the Curve Within a 21-Day Dosing Interval (AUC0-21) in Adult Subjects	Gammaplex 10%	AUC(0-t) absolute	0.99	90% Confidence Interval 0.95 to 1.02	ratio Gammaplex 10%/Gammaplex 5%
Secondary Bioequivalence Analysis - Area Under the Curve Within a 21-Day Dosing Interval (AUC0-21) in Adult Subjects	Gammaplex 5%	AUC(0-t) absolute	0.99	90% Confidence Interval 0.95 to 1.02	ratio Gammaplex 10%/Gammaplex 5%
Secondary Bioequivalence Analysis - Area Under the Curve Within a 21-Day Dosing Interval (AUC0-21) in Adult Subjects	Gammaplex 10%	AUC(0-t) baseline-adjusted	1.10	90% Confidence Interval 0.96 to 1.26	ratio Gammaplex 10%/Gammaplex 5%
Secondary Bioequivalence Analysis - Area Under the Curve Within a 21-Day Dosing Interval (AUC0-21) in Adult Subjects	Gammaplex 5%	AUC(0-t) baseline-adjusted	1.10	90% Confidence Interval 0.96 to 1.26	ratio Gammaplex 10%/Gammaplex 5%
Secondary Bioequivalence Analysis - IgG Trough Levels	Gammaplex 10%	28-day dosing interval	0.98	90% Confidence Interval 0.94 to 1.02	ratio Gammaplex 10%/Gammaplex 5%
Secondary Bioequivalence Analysis - IgG Trough Levels	Gammaplex 5%	28-day dosing interval	0.98	90% Confidence Interval 0.94 to 1.02	ratio Gammaplex 10%/Gammaplex 5%

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment Sequence 1 - Adults	14
Overall Study	STARTED	Treatment Sequence 2 - Adults	19
Overall Study	STARTED	Pediatrics	15
Overall Study	COMPLETED	Treatment Sequence 1 - Adults	14
Overall Study	COMPLETED	Treatment Sequence 2 - Adults	18
Overall Study	COMPLETED	Pediatrics	14
Overall Study	NOT COMPLETED	Treatment Sequence 1 - Adults	0
Overall Study	NOT COMPLETED	Treatment Sequence 2 - Adults	1
Overall Study	NOT COMPLETED	Pediatrics	1

Source ClinicalTrials.gov

Adverse events52

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 respiratory tract infection	Infections and infestations	Gammaplex 5% - All Subjects	2	33	2
other	Upper respiratory tract infection	Infections and infestations	Gammaplex 10% - All Subjects	8	47	8
other	Nasopharyngitis	Infections and infestations	Gammaplex 5% - All Subjects	1	33	2
other	Nasopharyngitis	Infections and infestations	Gammaplex 10% - All Subjects	5	47	7
other	Viral upper respiratory tract infection	Infections and infestations	Gammaplex 5% - All Subjects	4	33	5
other	Viral upper respiratory tract infection	Infections and infestations	Gammaplex 10% - All Subjects	4	47	5
other	Acute sinusitis	Infections and infestations	Gammaplex 5% - All Subjects	5	33	6
other	Acute sinusitis	Infections and infestations	Gammaplex 10% - All Subjects	3	47	3
other	Chronic sinusitis	Infections and infestations	Gammaplex 5% - All Subjects	2	33	2
other	Chronic sinusitis	Infections and infestations	Gammaplex 10% - All Subjects	4	47	4

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Gammaplex 5% - All Subjects	0	33
Total, all-cause mortality	Gammaplex 10% - All Subjects	0	47
Total, other adverse events	Gammaplex 5% - All Subjects	23	33
Total, other adverse events	Gammaplex 10% - All Subjects	44	47
Total, serious adverse events	Gammaplex 5% - All Subjects	2	33
Total, serious adverse events	Gammaplex 10% - All Subjects	1	47

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
36818468	DERIVED	PubMed
39271296	DERIVED	PubMed
39919133	DERIVED	PubMed
41773292	DERIVED	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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Gammaplex 5% - All Subjects vs Gammaplex 10% - All Subjects: deaths from any cause	Trial comparisons
Gammaplex 5% - All Subjects vs Gammaplex 10% - All Subjects: serious adverse events	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01963143

GET https://conductscience.org/api/trials/v1/NCT01963143/events?page=2

API reference For AI assistants