Clinical and Molecular Aspects of Adult Onset Pompe Disease: a Natural History Study

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The project is a prospective study in which patients affected by adult-onset Pompe disease with c.-32-13T\>G mutation in the GAA gene will be followed-up during two years to describe the natural history using clinical, imaging, histological and molecular parameters. Secondary objectives are: * To identify biomarkers for assessing efficacy of future therapies based on correcting aberrant alternative splicing in Pompe patients with c.-32-13T\>G mutations. * To determine effectiveness of antisense oligonucleotide chemistries to restore full length GAA transcripts, GAA protein and GAA enzyme activity in fibroblasts and myoblasts obtained from skin and muscle biopsies as well as leucocytes of Pompe patients with c.-32-13T\>G mutations.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Pompe disease Patient with c.-32-13T\>G mutation in at least one allele of GAA gene.

• Ambulating patient : six-minute walk test distance \> 50 m.

• Patient aged between 18 and 80 years.

• Informed consent signed par patient.

• Patient covered by a health insurance.

Locations
Other Locations
France
Hôpital Raymond Poincaré
RECRUITING
Garches
Contact Information
Primary
Helge Amthor, MD, PhD
helge.amthor@aphp.fr
+ 33 1 47 10 78 90
Backup
Pascal Laforêt, MD, PhD
pascal.laforet@aphp.fr
+ 33 1 47 10 37 76
Time Frame
Start Date: 2019-06-07
Estimated Completion Date: 2033-03
Participants
Target number of participants: 20
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov