A Study Comparing the Pharmacokinetics and Tolerance of D-Gam® to Rhophylac® in Rh-D-negative Healthy Volunteers.

March 12, 2018 updated by: Bio Products Laboratory

A Randomised Study Comparing the Pharmacokinetics and Tolerance of D-Gam® 1500IU to Rhophylac® 1500IUin Rh-D-negative Healthy Volunteers.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Occam Road, Guildford, Surrey
      • Unit 34, Surrey Technology Centre, Surrey Research Park, Occam Road, Guildford, Surrey, United Kingdom, GU2 7YG
        • Guildford Clinical Pharmacology Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Pre-dose, 1, 8, 24, 32, 48, 72 & 96 hours; 1, 2, 3, 4, 5, 6, 8, 10, 12 & 14 weeks post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bio Products Laboratory

Investigators

  • Principal Investigator: Dr A Sutton, MB BS, FFARCSI, Guildford Clinical Pharmacology Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

September 15, 2014

First Submitted That Met QC Criteria

September 19, 2014

First Posted (Estimate)

September 23, 2014

Study Record Updates

Last Update Posted (Actual)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POLYAD04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on D-Gam® (human anti-D immunoglobulin)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe