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Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases (GMX07)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01963143
Recruitment Status : Completed
First Posted : October 16, 2013
Results First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Bio Products Laboratory

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Primary Immune Deficiency Disorders
Common Variable Immunodeficiency
X-linked Agammaglobulinaemia
Hyper-IgM Syndrome
Interventions Biological: Gammaplex (5%)
Biological: Gammaplex 10
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Sequence 1 - Adults Treatment Sequence 2 - Adults Pediatrics
Hide Arm/Group Description Gammaplex 5% & Gammaplex 10 on a 21-day treatment schedule Gammaplex 10 and Gammaplex 5% on a 28-day treatment schedule Gammaplex 10 on a 21 or 28 day treatment schedule
Period Title: Overall Study
Started 14 19 15
Completed 14 18 14
Not Completed 0 1 1
Arm/Group Title Treatment Sequence 1 - Adults Treatment Sequence 2 - Adults Pediatrics Total
Hide Arm/Group Description Gammaplex 5% and Gammaplex 10 on a 21-day schedule Gammaplex 5% and Gammaplex 10 on a 28-day schedule Gammaplex 10 on a 21 or 28 day schedule Total of all reporting groups
Overall Number of Baseline Participants 14 19 15 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 19 participants 15 participants 48 participants
<=18 years
1
   7.1%
1
   5.3%
15
 100.0%
17
  35.4%
Between 18 and 65 years
13
  92.9%
18
  94.7%
0
   0.0%
31
  64.6%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 19 participants 15 participants 48 participants
Female
12
  85.7%
9
  47.4%
7
  46.7%
28
  58.3%
Male
2
  14.3%
10
  52.6%
8
  53.3%
20
  41.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 19 participants 15 participants 48 participants
Hispanic or Latino
0
   0.0%
1
   5.3%
2
  13.3%
3
   6.3%
Not Hispanic or Latino
14
 100.0%
18
  94.7%
13
  86.7%
45
  93.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 19 participants 15 participants 48 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
14
 100.0%
19
 100.0%
15
 100.0%
48
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 19 participants 15 participants 48 participants
Hungary 0 0 1 1
United States 11 19 14 44
United Kingdom 3 0 0 3
1.Primary Outcome
Title Primary Bioequivalence Analysis - Area Under the Curve Within a 28-day Dosing Interval (AUC0-28) in Adult Subjects
Hide Description [Not Specified]
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title Gammaplex 10% Gammaplex 5%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 16 16
Geometric Mean (90% Confidence Interval)
Unit of Measure: ratio Gammaplex 10%/Gammaplex 5%
AUC(0-t) absolute
1.01
(0.98 to 1.03)
1.01
(0.98 to 1.03)
AUC(0-t) baseline-adjusted
1.07
(0.93 to 1.23)
1.07
(0.93 to 1.23)
2.Secondary Outcome
Title Secondary Bioequivalence Analysis - Area Under the Curve Within a 21-Day Dosing Interval (AUC0-21) in Adult Subjects
Hide Description [Not Specified]
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gammaplex 10% Gammaplex 5%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 14 14
Geometric Mean (90% Confidence Interval)
Unit of Measure: ratio Gammaplex 10%/Gammaplex 5%
AUC(0-t) absolute
0.99
(0.95 to 1.02)
0.99
(0.95 to 1.02)
AUC(0-t) baseline-adjusted
1.10
(0.96 to 1.26)
1.10
(0.96 to 1.26)
3.Secondary Outcome
Title Secondary Bioequivalence Analysis - IgG Trough Levels
Hide Description [Not Specified]
Time Frame After a minimum 5 infusions on each product, at pre-infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gammaplex 10% Gammaplex 5%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 30 30
Geometric Mean (90% Confidence Interval)
Unit of Measure: ratio Gammaplex 10%/Gammaplex 5%
28-day dosing interval
0.98
(0.94 to 1.02)
0.98
(0.94 to 1.02)
21-day dosing interval
0.95
(0.92 to 0.99)
0.95
(0.92 to 0.99)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gammaplex 5% - All Subjects Gammaplex 10% - All Subjects
Hide Arm/Group Description Subjects aged 17-55 years Subjects aged 2-55 years
All-Cause Mortality
Gammaplex 5% - All Subjects Gammaplex 10% - All Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)      0/47 (0.00%)    
Hide Serious Adverse Events
Gammaplex 5% - All Subjects Gammaplex 10% - All Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/33 (6.06%)      1/47 (2.13%)    
Immune system disorders     
Anaphylactic reaction  0/33 (0.00%)  0 1/47 (2.13%)  2
Injury, poisoning and procedural complications     
Craniocerebral injury  1/33 (3.03%)  1 0/47 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neuroendocrine tumour  1/33 (3.03%)  1 0/47 (0.00%)  0
Nervous system disorders     
IIIrd nerve paralysis  1/33 (3.03%)  1 0/47 (0.00%)  0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gammaplex 5% - All Subjects Gammaplex 10% - All Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/33 (69.70%)      44/47 (93.62%)    
Gastrointestinal disorders     
Diarrhoea  2/33 (6.06%)  2 2/47 (4.26%)  2
Nausea  3/33 (9.09%)  3 1/47 (2.13%)  1
General disorders     
Fatigue  3/33 (9.09%)  7 1/47 (2.13%)  5
Pyrexia  0/33 (0.00%)  0 3/47 (6.38%)  3
Infections and infestations     
Upper respiratory tract infection  2/33 (6.06%)  2 8/47 (17.02%)  8
Nasopharyngitis  1/33 (3.03%)  2 5/47 (10.64%)  7
Viral upper respiratory tract infection  4/33 (12.12%)  5 4/47 (8.51%)  5
Acute sinusitis  5/33 (15.15%)  6 3/47 (6.38%)  3
Chronic sinusitis  2/33 (6.06%)  2 4/47 (8.51%)  4
Sinusitis  1/33 (3.03%)  1 7/47 (14.89%)  7
Influenza  0/33 (0.00%)  0 6/47 (12.77%)  6
Bronchitis  3/33 (9.09%)  3 0/47 (0.00%)  0
Injury, poisoning and procedural complications     
Ligament sprain  2/33 (6.06%)  2 0/47 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1/33 (3.03%)  2 3/47 (6.38%)  4
Nervous system disorders     
Headache  6/33 (18.18%)  16 11/47 (23.40%)  28
Migraine  3/33 (9.09%)  4 3/47 (6.38%)  4
Psychiatric disorders     
Insomnia  3/33 (9.09%)  3 0/47 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  2/33 (6.06%)  2 4/47 (8.51%)  4
Oropharyngeal pain  3/33 (9.09%)  3 2/47 (4.26%)  2
Rales  2/33 (6.06%)  2 0/47 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash  0/33 (0.00%)  0 5/47 (10.64%)  6
Dermatitis  3/33 (9.09%)  3 1/47 (2.13%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head of Medical Information
Organization: Bio Products Laboratory
Phone: +44 (0)20 8957 2200
EMail: medinfo@bpl.co.uk
Layout table for additonal information
Responsible Party: Bio Products Laboratory
ClinicalTrials.gov Identifier: NCT01963143    
Other Study ID Numbers: GMX07
First Submitted: September 13, 2013
First Posted: October 16, 2013
Results First Submitted: February 10, 2017
Results First Posted: March 29, 2017
Last Update Posted: March 29, 2017