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Clinical Trial Report

Gene Therapy Trial Report

Summary

Effect of AdhAQP1 on Salivary Flow in Patients Treated With Radiation for Head and Neck Cancer


NCTID NCT00372320 (View at clinicaltrials.gov)
Description
Development Status Inactive
Indication Parotid Salivary Dysfunction
Disease Ontology Term DOID:10854
Compound Name AdhAQP1
Compound Description Ad5.hCMVp.hAQP1
Sponsor National Institute of Dental and Craniofacial Research (NIDCR)
Funder Type NIH
Recruitment Status
Completed
Enrollment Count 17
Results Posted Not Available

Therapy Information


Target Gene/Variant AQP1
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Overexpression of protective allele/gene
Route of Administration Parotid
Drug Product Type Viral vector
Target Tissue/Cell Ductal cells
Delivery System Viral transduction
Vector Type Ad5
Editor Type
Dose 1 4.8E7 vp/gland (n=3)
Dose 2 2.9E8 vp/gland (n=3)
Dose 3 1.3E9 vp/gland (n=3)
Dose 4 5.8E9 vp/gland (n=2)
Dose 5

Study Record Dates


Current Stage Phase1
Submit Date 2006-09-02
Completion Date 2018-09-05
Last Update 2018-09-11

Participation Criteria


Eligible Age >=18 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL

Locations


No.of Trial Sites 1
Locations United States

Regulatory Information


Has US IND True
FDA Designations
Recent Updates Therapy was safe, but does not provide long-term benefit and redosing is not indicated with adenoviral vector. This program was transferred to MeiraGTx, who changed the vector to AAV2

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