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CompletedNCT02246842Updated Mar 14, 2018

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

A Phase 1 interventional study of D-Gam® (human anti-D immunoglobulin) and Rhophylac® (human anti-D immunoglobulin) in Healthy, sponsored by Bio Products Laboratory. Completed at 1 site in United Kingdom. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-14.

Sponsored by Bio Products Laboratory · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Sex
Female
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • Volunteers
03

In context

Lead sponsor

Bio Products Laboratory is the lead sponsor of 27 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • abnormalities at physical examination, or laboratory tests.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Phase 1
Primary purpose
Treatment

Study arms

  • 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)

Interventions

  • BiologicalD-Gam® (human anti-D immunoglobulin)
  • BiologicalRhophylac® (human anti-D immunoglobulin)
06

What researchers measure

Primary outcomes

  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

07

Study locations

1 site
  • Guildford Clinical Pharmacology Unit
    Unit 34, Surrey Technology Centre, Surrey Research Park, Occam Road, Guildford, Surrey GU2 7YG, United Kingdom
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2004 and a primary completion of Dec 2004. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2014
First posted
Sep 23, 2014
Start
May 2004
Primary completionActual
Dec 2004
Last update
Mar 14, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02246842
Lead sponsor
Bio Products Laboratory
Responsible party
Sponsor
First posted
Sep 23, 2014
Start date
May 2004
Primary completion
Dec 2004
Last update
Mar 14, 2018

Study contacts

Dr A Sutton, MB BS, FFARCSI
principal investigator · Guildford Clinical Pharmacology Unit
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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