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A Study Comparing the Pharmacokinetics and Tolerance of D-Gam® to Rhophylac® in Rh-D-negative 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: NCT02246842
Recruitment Status : Completed
First Posted : September 23, 2014
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Bio Products Laboratory

Brief Summary:
The primary objective of the study was to compare peak serum anti-D levels (Cmax) of BPL's D-Gam® 1500 IU to Rhophylac® 1500IU in RhD-negative healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Biological: D-Gam® (human anti-D immunoglobulin) Biological: Rhophylac® (human anti-D immunoglobulin) Phase 1

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Randomised Study Comparing the Pharmacokinetics and Tolerance of D-Gam® 1500IU to Rhophylac® 1500IUin Rh-D-negative Healthy Volunteers.
Study Start Date : May 2004
Actual Primary Completion Date : December 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: D-Gam®
D-Gam® (human anti-D immunoglobulin)
Biological: D-Gam® (human anti-D immunoglobulin)
Active Comparator: Rhophylac®
Human Anti-D Immunoglobulin
Biological: Rhophylac® (human anti-D immunoglobulin)



Primary Outcome Measures :
  1. Cmax for anti-D [ Time Frame: Pre-dose, 1, 8, 24, 32, 48, 72 & 96 hours; 1, 2, 3, 4, 5, 6, 8, 10, 12 & 14 weeks post-dose ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Females
  • Ages of 18 and 55 years
  • Bodyweight of 50-85kg.

Exclusion Criteria:

  • Clinically relevant abnormalities at physical examination, ECG or laboratory tests.

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): NCT02246842


Locations
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United Kingdom
Guildford Clinical Pharmacology Unit
Unit 34, Surrey Technology Centre, Surrey Research Park, Occam Road, Guildford, Surrey, United Kingdom, GU2 7YG
Sponsors and Collaborators
Bio Products Laboratory
Investigators
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Principal Investigator: Dr A Sutton, MB BS, FFARCSI Guildford Clinical Pharmacology Unit

Additional Information:
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Responsible Party: Bio Products Laboratory
ClinicalTrials.gov Identifier: NCT02246842    
Other Study ID Numbers: POLYAD04
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Keywords provided by Bio Products Laboratory:
Volunteers
Additional relevant MeSH terms:
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Immunoglobulins
Antibodies
Rho(D) Immune Globulin
gamma-Globulins
Immunoglobulins, Intravenous
Immunologic Factors
Physiological Effects of Drugs