HealthyPhase 1NCT02246842
A Study Comparing the Pharmacokinetics and Tolerance of D-Gam® to Rhophylac® in Rh-D-negative Healthy Volunteers.
A Phase 1 study testing D-Gam® (human anti-D immunoglobulin) and Rhophylac® (human anti-D immunoglobulin) in people with Healthy, run by Bio Products Laboratory at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- D-Gam® (human anti-D immunoglobulin) and Rhophylac® (human anti-D immunoglobulin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2004to Dec 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Females
- Ages of 18 and 55 years
- Bodyweight of 50-85kg.
Who cannot join
- Clinically relevant abnormalities at physical examination, ECG or laboratory tests.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guildford Clinical Pharmacology Unit
Unit 34, Surrey Technology Centre, Surrey Research Park, Occam Road, Guildford, Surrey, GU2 7YG
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- D-Gam® (human anti-D immunoglobulin), Rhophylac® (human anti-D immunoglobulin)
- Keywords
- Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-Gam® (human anti-D immunoglobulin)Biological
Rhophylac® (human anti-D immunoglobulin)Biological
| Study group | Role | What they receive |
|---|---|---|
| D-Gam® | Experimental | D-Gam® (human anti-D immunoglobulin) Receives: Biological: D-Gam® (human anti-D immunoglobulin) |
| Rhophylac® | Active comparator | Human Anti-D Immunoglobulin Receives: Biological: Rhophylac® (human anti-D immunoglobulin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax for anti-D
Measured: Pre-dose, 1, 8, 24, 32, 48, 72 & 96 hours; 1, 2, 3, 4, 5, 6, 8, 10, 12 & 14 weeks post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startMay 2004
- Primary completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Bio Products Laboratory
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr A Sutton, MB BS, FFARCSI, Principal investigator, Guildford Clinical Pharmacology Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246842
- Sponsor's protocol ID
- POLYAD04
- Status last verified
- Mar 2018
- First submitted
- 15 Sep 2014
- Last updated
- 14 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Study Comparing the Pharmacokinetics and Tolerance of D-Gam® 1500IU to Rhophylac® 1500IUin Rh-D-negative Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT02246842
- Acronym / sponsor ID
- POLYAD04
- Conditions
- Healthy
- Keywords
- Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bio Products LaboratoryUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Dec 2004 (actual)
- First posted
- 23 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-Gam® | Experimental | Biological: D-Gam® (human anti-D immunoglobulin)D-Gam® (human anti-D immunoglobulin) |
| Rhophylac® | Active comparator | Biological: Rhophylac® (human anti-D immunoglobulin)Human Anti-D Immunoglobulin |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Females
- Ages of 18 and 55 years
- Bodyweight of 50-85kg.
Key exclusion criteria (1 listed)
- Clinically relevant abnormalities at physical examination, ECG or laboratory tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-Gam® (human anti-D immunoglobulin) | Biological | D-Gam® |
| Rhophylac® (human anti-D immunoglobulin) | Biological | Rhophylac® |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Sponsor's HomepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr A Sutton, MB BS, FFARCSI principal investigator
Guildford Clinical Pharmacology Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing D-Gam® (human anti-D immunoglobulin) and Rhophylac® (human anti-D immunoglobulin) in people with Healthy, run by Bio Products Laboratory at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.