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Oculocerebrorenal SyndromeLOWENCT01314560

Study of the Pathophysiological Mechanisms Involved in Bleeding Events

A study testing Blood sample in people with Oculocerebrorenal Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Lowe syndrome is associated with mutations in the OCRL1 gene, which encodes OCRL1, a phosphatidylinositol-4, 5-bisphosphate (PtdIns(4, 5)P (2))5-phosphatase. PtdIns(4, 5)P2, a substrate of OCRL1, is an important signaling molecule within the cell. Read more about this study

Who is it for?
Ages 6 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Oculocerebrorenal Syndrome
What is being tested?
Blood sample
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteFrance
Study dates
Feb 2009to Dec 2010
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 6 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Patient with a clinical syndrome of Lowe (congenital cataracts, renal tubular dysfunction and neuromuscular damage) with a molecular defect in the gene known OCRL1.
  • For the centre of Necker, patients should have a weight> 10 kg. For the centre of Toulouse site, patients should have a weight> 40 kg.
  • No alteration of glomerular function (creatinine clearance> 30 ml/min/1.73m ²)
  • No significant anemia (hematocrit> 25%, hemoglobin> 8 g / L)
  • Every patient should have included a signed informed consent. For minor patients, the consent of parents or legal guardian must be obtained.
  • Patients may be included only if they receive social security coverage or CMU

Who cannot join

  • Weight less than 10 kg for the centre of Necker
  • Weight less than 40 kg for the centre of Toulouse
  • Major renal insufficiency (creatinine clearance <30 ml/min/1.73m ²)
  • Profound anemia (hematocrit <25%, Hb <8g/dl)
  • Patients taking drugs interfering with hemostasis in the eight days before the survey
  • Patients with major behavior disorder making it difficult to achieve the blood sample, despite the nitrous oxide
Show all 10Show fewer
  • Patients with a other pathology of hemostasis (hemophilia, thrombotic disease)
  • Participation in another clinical study requiring a blood sample within 4 weeks
  • Contraindication to EMLA patch: confers Summary of Product Characteristics.
  • Contraindication to KALINOX: confers Summary of Product Characteristics.

Trial locations and contacts

1 site in 1 country.

France1 site
  • Necker Enfants Malades Hospital, Genetic

    Paris, 75015

Other trials in France

About this study

Official title: Study of the Pathophysiological Mechanisms Involved in Bleeding Events Observed in Patients With Lowe Syndrome

Lowe syndrome is associated with mutations in the OCRL1 gene, which encodes OCRL1, a phosphatidylinositol-4, 5-bisphosphate (PtdIns(4, 5)P (2))5-phosphatase. PtdIns(4, 5)P2, a substrate of OCRL1, is an important signaling molecule within the cell. An abnormal rate of hemorrhagic events was found in a retrospective clinical survey, suggesting platelet dysfunction.

The main objective of the study is to confirm the presence of platelet dysfunction in Lowe syndrome and to characterize this abnormality.

Read the detailed description

Introduction: Lowe syndrome (LS), also known as oculocerebrorenal syndrome of Lowe (OCRL), is a rare X-linked condition characterized by congenital cataracts, defective renal tubule cell function, muscular hypotonia and variable degrees of mental retardation. Patients with LS require frequent surgery, some of which are associated with a severe haemorrhagic risk, such as scoliosis reduction, hip surgery, or eye surgery. In a recent retrospective clinical survey of French LS patients, we observed an abnormal rate of haemorrhagic events, some of which had dramatic outcomes. LS is caused BYMUTATIONS in the OCRL gene, which encodes OCRL, an inositol polyphosphate 5-phosphatase. The preferred OCRLsubstrate is the membrane phospholipid phosphatidylinositol-4,5-bisphosphate (PtdIns(4,5)P2). OCRL also contains a Rho GTPase-activating protein(GAP)-like domain that participates in the regulation of Rho proteins (Rho, Rac, Cdc42), as GTPase-activating proteins or by mediating in protein-protein interactions. PtdIns(4,5)P2 and Rho-dependent signalling play a central role in many important cellular processes, including vesicular trafficking and cytoskeletal organization both of which are very important for platelet function. Thus, modulation of PtdIns(4,5)P2 levels and/or Rho-dependent signalling would be expected to impact platelet function.

Based on the clinical observation, we tested whether hemorrhagic symptom of 6 Lowe patients could be related to homeostasis abnormalities and we found that all the six patients had a prolonged closure time tested by PFA100 analyzer (Platelet Function Analyzer). These results were measured in absence of interfering factor such anemia, thrombopenia, or von Willebrand factor deficiency, thus suggesting platelet dysfunction.

Study justification:

The comprehension of the physiopathology implicated in the abnormal hemorrhagic risk is of major interest in term of prevention and clinical management in Lowe patients who requires frequent surgical care.

Objectives:

The main objective of the study is to confirm the presence of platelet dysfunction in Lowe syndrome and to characterize this abnormality. The secondary aims are to settle a functional test allowing the detection of patients with increasing hemorrhagic risk. Moreover, we could determinate whether platelet is an interesting cellular model, easily available, for further OCRL1 studies in Lowe patients.

Methods:

We will investigate platelet activation response in 15 Lowe cases and 15 normal cases. The evaluation criteria will include the PFA100, THROMBOELASTOMETRY (ROTEM), aggregation, secretion, adhesion in a flux system and clot retraction. We will also compare molecular (phospho-proteins, phospholipid...) and structural modifications of the non activated platelet and of activating platelet.

Conclusion:

The characterization of a platelet activation abnormality in Lowe patients could lead to major benefit for the patients with systematic homeostasis screening and special precautions rules before surgery, often required in this multisystemic condition. Moreover, this study could contribute to go further into PI(4,5)P2 signaling pathways and may provide clues to the interrelationship between these processes in normal metabolism and diseases states.

Being tested
Blood sample
Keywords
Lowe syndrome, OCRL, Haemostasis, Bleeding Disorders, Platelet Function Tests
Medical subject headings
Oculocerebrorenal Syndrome, Hemostatic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood sampleOther

    Blood sample

Study groups in NCT01314560
Study groupRoleWhat they receive
1Experimentalexperimental
Receives: Other: Blood sample

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The platelet function will be evaluated by comparing the intensity of platelet responses obtained in patient and controls

    The platelet function will be evaluated by comparing the intensity of platelet responses obtained in patient and controls. Various platelet responses will be studied:

    • The measurement of platelet closure time by PFA100
    • Aggregation, retraction, secretion and adhesion

    Measured: 18 months

Secondary outcomes (1)
  1. Characterization of abnormalities in platelet-signalling pathways

    Characterization of abnormalities in platelet-signalling pathways

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2011 (estimated)
  2. Study startFeb 2009
  3. Primary completionJul 2010
  4. Study completionDec 2010

Resources

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
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01314560
Sponsor's protocol ID
P071008
Acronym
LOWE
Status last verified
Oct 2025
First submitted
11 Mar 2011
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
No

Publications

  • Egot M, Lasne D, Poirault-Chassac S, Mirault T, Pidard D, Dreano E, Elie C, Gandrille S, Marchelli A, Baruch D, Rendu J, Faure J, Flaujac C, Gratacap MP, Sie P, Gaussem P, Salomon R, Baujat G, Bachelot-Loza C. Role of oculocerebrorenal syndrome of Lowe (OCRL) protein in megakaryocyte maturation, platelet production and functions: a study in patients with Lowe syndrome. Br J Haematol. 2021 Mar;192(5):909-921. doi: 10.1111/bjh.17346. Epub 2021 Feb 2.

    PubMed 33528045

Questions about this trial

What is this clinical trial studying?

A study testing Blood sample in people with Oculocerebrorenal Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 6 inclusion and 10 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 20 Nov 2025. 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 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?

The platelet function will be evaluated by comparing the intensity of platelet responses obtained in patient and controls (time frame: 18 months). 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 NCT01314560, 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 20 Nov 2025.

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