An Exploratory Study to Evaluate the Tolerability and Safety of MWAV201 in Subjects With Wilson D… (NCT06663878) | Clinical Trial Compass
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An Exploratory Study to Evaluate the Tolerability and Safety of MWAV201 in Subjects With Wilson Disease
China9 participantsStarted 2024-10
Plain-language summary
The primary objective of this study is to evaluate the tolerability and safety of MWAV201 in patients with Wilson disease.
Who can participate
Age range18 Years – 65 Years
SexALL
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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.
What they're measuring
1
Safety and tolerability profile [including adverse events (AEs) and serious adverse events (SAEs)]
Timeframe: At 1-Year post treatment
Trial details
NCT IDNCT06663878
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine