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Oral Pyrophosphate Absorption in PXE Disease

Oral Disodiumpyrophosphate (Na2H2PPi) Absorption in Pseudoxanthoma Elasticum - Oral Pyrophosphate Absorption in PXE

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2019-002109-24-FI
Enrollment
10
Registered
2019-07-01
Start date
2019-08-01
Completion date
Unknown
Last updated
2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pseudoxanthoma elasticum

Interventions

Product Name: Disodiumpyrophosphate Pharmaceutical Form: Oral powder

Sponsors

Tampere University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adults (>18 yrs) when they have a clinically and genetically proven PXE. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Special groups according to researchers' decision. Pregnancy. No effective contraception in females in child-bearing age.

Design outcomes

Primary

MeasureTime frame
Main Objective: Phase II trial: to find optimal dosing and safety of oral disodium- PPi. Absorption curves (pharmacokinetics) will be provided for PXE-patients.;Secondary Objective: Not applicaple;Primary end point(s): absorption curves and adverse events;Timepoint(s) of evaluation of this end point: Two days of absoprtion kinetics

Secondary

MeasureTime frame
Secondary end point(s): None

Countries

Finland

Contacts

Public ContactPasi Nevalainen

Tampere University Hospital

pasinevalainen@pshp.fi358504019405

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026