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Gene Therapy Trial Report

Summary

An Exploratory Study to Evaluate the Tolerability and Safety of MWAV201 in Subjects With Wilson Disease


NCTID NCT06663878 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Wilson Disease
Disease Ontology Term DOID:893
Compound Name MWAV201
Sponsor Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Funder Type Other
Recruitment Status
Not yet recruiting
Enrollment Count 9 (ESTIMATED)
Results Posted Not Available

Therapy Information


Target Gene/Variant Undisclosed
Therapy Type Undisclosed
Therapy Route Undisclosed
Mechanism of Action Undisclosed
Route of Administration Intravenous
Drug Product Type Undisclosed
Delivery System Undisclosed
Vector Type undisclosed
Editor Type undisclosed
Dose 1 Undisclosed

Study Record Dates


Current Stage Na
Submit Date 2024-10-10
Completion Date 2031-05
Last Update 2024-10-29

Participation Criteria


Eligible Age 18 Years - 65 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL
Eligibility Criteria
Inclusion Criteria: * Male or female aged 18 and 65 years inclusive; * Confirmed diagnosis of Wilson disease; * Low copper diet and standardized medication for ≥ 1 year; * Stable Wilson disease for ≥ 1 year; * Able to understand and willing to follow study procedures. Exclusion Criteria: * Significant hepatic inflammation as evidenced by liver function test. * Liver biopsy or liver stiffness measurement show progressive liver fibrosis. * Laboratory tests or clinical symptoms indicate decreased liver reserve function. * Other chronic liver disease (such as hepatitis B). * Any signs of decompensated liver function (such as ascites). * History of liver transplant or plan to receive liver transplant. * Other diseases with clinical significance, such as cardiovascular and cerebrovascular diseases, kidney diseases, respiratory system diseases, neurological diseases, mental illnesses, active infections, etc. * Body Mass Index ≥ 30 kg/m2. * Other conditions that, in the Investigator's opinion, may not be suitable for the subject to be enrolled.
View Inclusion and Exclusion Criteria at ClinicalTrials.gov

Locations


No.of Trial Sites 1
Locations China

Regulatory Information


Has US IND False
FDA Designations
Recent Updates

Resources/Links


Resources/Links

No External Links Available.