Patients With Gaucher's DiseaseGaucherNCT01206673
Macrophagic Activation and Immunophenotypic Profile of Patients With Gaucher's Disease
A study testing Blood sampling in people with Patients With Gaucher's Disease, run by Nantes University Hospital at 2 sites in France.
Trial summary
The aim of this study is to evaluate macrophaging activity and immunologic profile of patients with Gaucher 's disease. For this, one blood sampling will be performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Gaucher's Disease
- What is being tested?
- Blood sampling
- How many people
- 10 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2009to Jul 2011
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (age equal or above 18.
- Patients with Gaucher 's disease treated in the "Grand Ouest" competence center
- patients affiliated to social security
- Informed consent signed
Who cannot join
- Children (age<18)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Evaluation of Macrophagic Activation and Immunophenotypic Profile of Patients With Gaucher's Disease.
The aim of this study is to evaluate macrophaging activity and immunologic profile of patients with Gaucher 's disease. For this, one blood sampling will be performed.
- Conditions
- Patients With Gaucher's Disease
- Being tested
- Blood sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
One blood sampling is required for the research
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the implication of acquired and inherent immunity in the Gaucher's clinical phenotype at moment of blood sampling
Secondary outcomes (1)
to find new activity mark for Gaucher's disease by studying macrophagic activation's markers.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startDec 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Gaucher's DiseaseStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206673
- Sponsor's protocol ID
- BRD/09/07-I
- Acronym
- Gaucher
- Status last verified
- Dec 2011
- First submitted
- 21 Sep 2010
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Braudeau C, Graveleau J, Rimbert M, Neel A, Hamidou M, Grosbois B, Besancon A, Giraudet S, Terrien C, Josien R, Masseau A. Altered innate function of plasmacytoid dendritic cells restored by enzyme replacement therapy in Gaucher disease. Blood Cells Mol Dis. 2013 Apr;50(4):281-8. doi: 10.1016/j.bcmd.2013.01.001. Epub 2013 Jan 26.
PubMed 23357793
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Macrophagic Activation and Immunophenotypic Profile of Patients With Gaucher's Disease.
- ClinicalTrials.gov ID
- NCT01206673
- Acronym / sponsor ID
- Gaucher / BRD/09/07-I
- Conditions
- Patients With Gaucher's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 22 Sep 2010 (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 aim of this study is to evaluate macrophaging activity and immunologic profile of patients with Gaucher 's disease. For this, one blood sampling will be performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (age equal or above 18.
- Patients with Gaucher 's disease treated in the "Grand Ouest" competence center
- patients affiliated to social security
- Informed consent signed
Key exclusion criteria (1 listed)
- Children (age<18)
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 |
|---|---|---|
| Blood samplingOne blood sampling is required for the research | Other | – |
Primary outcome
To determine the implication of acquired and inherent immunity in the Gaucher's clinical phenotype at moment of blood sampling
1 secondary outcome
to find new activity mark for Gaucher's disease by studying macrophagic activation's markers.
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 Sep 2026.
- Results publication: PubMed 23357793Braudeau C, Graveleau J, Rimbert M, Neel A, Hamidou M, Grosbois B, Besancon A, Giraudet S, Terrien C, Josien R, Masseau A. Altered innate function of plasmacytoid dendritic cells restored by enzyme replacement therapy in Gaucher disease. Blood Cells Mol Dis. 2013 Apr;50(4):281-8. doi: 10.1016/j.bcmd.2013.01.001. Epub 2013 Jan 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Patients With Gaucher's Disease, run by Nantes University Hospital at 2 sites in France.
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 4 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 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
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?
To determine the implication of acquired and inherent immunity in the Gaucher's clinical phenotype at moment of blood sampling. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01206673, which also lists 1 linked publication.
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 Sep 2026.