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A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg in Healthy Volunteers

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: NCT02246855
Recruitment Status : Completed
First Posted : September 23, 2014
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Bio Products Laboratory

Brief Summary:
The main object of the study is to compare the AUC0-84, of a single intravenous infusion of Vigam® Liquid (infused at the licensed rate of up to 3mL/min) with Gammaplex® (infused at up to 3mL/min and up to 6mL/min).

Condition or disease Intervention/treatment Phase
Healthy Biological: Gammaplex® (Human Normal Immunoglobulin) Phase 1

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg (Vigam® Liquid and Gammaplex®) Using Standard and Accelerated Infusion Rates in Healthy Adult Volunteers (Three Treatment Arms)
Study Start Date : August 2004
Actual Primary Completion Date : December 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Rhophylac

Arm Intervention/treatment
Experimental: Vigam® Liquid infused at up to 3mL/min
Gammaplex® (Human Normal Immunoglobulin)
Biological: Gammaplex® (Human Normal Immunoglobulin)
Experimental: Gammaplex® infused at up to 3mL/min
Gammaplex® (Human Normal Immunoglobulin)
Biological: Gammaplex® (Human Normal Immunoglobulin)
Experimental: Gammaplex® infused at up to 6mL/min
Gammaplex® (Human Normal Immunoglobulin)
Biological: Gammaplex® (Human Normal Immunoglobulin)



Primary Outcome Measures :
  1. PK parameters for serum immunoglobulin G (IgG) [ Time Frame: Screening, pre-dose (Day 1), 15 min, 4 hr, 24 hr, 30 hr, 48 hr, Days 4, 8, 11, 15, 18, 22, 29, 36, 43, 50, 57, 71, 85 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, normotensive, non-smoking male and female volunteers aged 18 to 60 who gave written informed consent and fulfilled all of the inclusion criteria and none of the exclusion criteria.
  • Female volunteers of childbearing potential had a negative pregnancy test before entering the study and had to use either a double barrier method of contraception or use the oral contraceptive pill.
  • Postmenopausal or surgically sterile female volunteers could be enrolled.

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246855


Locations
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United Kingdom
Clinical Pharmacology Research Unit (CPRU)
Level 7, Northwick Park Hospital, Watford Road, Harrow, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Bio Products Laboratory
Investigators
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Principal Investigator: David Wessels, MBChB MBA

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Responsible Party: Bio Products Laboratory
ClinicalTrials.gov Identifier: NCT02246855    
Other Study ID Numbers: GMX03
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: August 2014
Keywords provided by Bio Products Laboratory:
Subjects
Additional relevant MeSH terms:
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Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs