A Phase 1/2 interventional study of LY-M003 Injection and LY-M003 Injection in Wilson's Disease, sponsored by Lingyi Biotech Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Lingyi Biotech Co., Ltd. · Phase 1/2, Interventional, and Treatment
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Among 15 studies in Hepatolenticular Degeneration with a site in China — 10 open to participants now, 11 under way, 1 of them phase 3. Hepatolenticular Degeneration · China.
Among the 15 studies in Hepatolenticular Degeneration with a site in China, this one is one of 2 that started in 2026, is one of 2 in phase 1/2, reaches primary completion later than 6 of the 10 other live ones, and was the 15th registered.
80 studies on the registry are indexed under Hepatolenticular Degeneration; 31 are open to participants now.
Browse Hepatolenticular Degeneration studies →10 of the 15 studies in Hepatolenticular Degeneration with a site in China are open now. Recruiting first, the newest first:
Orphalan · Sites in China, United States, Pakistan and 1 more country
Ages 8+
DSciLab Co., Ltd. · Sites in China
Ages 18+
Chaohui Yu · Sites in China
Ages 10–60
Jun Li · Sites in China
Ages 15–65
Wan-Jin Chen · Sites in China
Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 21 Hepatolenticular Degeneration studies recruiting now, 16 (76%) set no upper age limit and 4 (19%) stop at 75 or younger; 14 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 2 · Phase 3 1 · Phase 4 1
First in 2004; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 18 is below the median of 30 across 44 interventional studies indexed under Hepatolenticular Degeneration.
Median enrollment 18 across the 9 interventional studies, 600 across the 6 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 15 have an industry lead sponsor. The 10 most frequent:
Lingyi Biotech Co., Ltd. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Lingyi Biotech Co., Ltd. has 1 study filed under Hepatolenticular Degeneration — fewer than ten, so there is no comparison to draw.
2 of the studies in Hepatolenticular Degeneration with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06650319Chaohui YuA Clinical Study to Evaluate the Safety and Efficacy of LY-M003 Injection in Patients With Wilson Disease | 2026-12-30 |
| NCT07173933GeneCradle IncPhase I/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of GC310 Injection in Patients With Wilson's Disease (WD) | 2027-04 |
Add all 2 to your calendar (.ics) → With an account.
Among the 15 studies in Hepatolenticular Degeneration with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This is a multicenter, open-label, single-arm, single-dose Phase I/II clinical study. It aims to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacodynamic (PD) and pharmacokinetic (PK) profiles of LY-M003 Injection in patients with Wilson's Disease (WD).
This is a multicenter, open-label, single-arm, single-dose Phase I/II clinical study. It aims to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacodynamic (PD) and pharmacokinetic (PK) profiles of LY-M003 Injection in patients with Wilson's Disease (WD). The Phase I/II study consists of a main study phase and a long-term follow-up phase. The main study phase includes an 8-week screening period and a 52-week follow-up period after infusion. The long-term follow-up phase starts at Week 53 and lasts until 5 years post-infusion.
The study pre-specified two dose cohorts, consisting of one main dose cohort and one de-escalation dose cohort: Dose Cohort 1 (4.0 × 10¹³ vg/kg) and the de-escalation dose cohort (2.0 × 10¹³ vg/kg). Three subjects will be enrolled in each dose cohort.Dose Cohort 1 serves as the starting dose. After the first subject receives the study drug, a minimum 28-day DLT observation period must be completed to confirm safety before enrolling subsequent subjects.All three subjects in Dose Cohort 1 have completed the 28-day (Day 28) DLT observation period following LY-M003 infusion. The Safety Review Committee (SRC) will make a comprehensive assessment to determine whether to proceed to the dose expansion phase at the dose level of 4.0 × 10¹³ vg/kg.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Genetic: LY-M003 Injection
Genetic: LY-M003 Injection
Genetic: LY-M003 Injection
Phase 1: Participants receive a single, peripheral intravenous (IV) infusion of LY-M003 at dose group 1.The dose for Dose Group 1 is 4.0 × 10¹³ vg/kg.All participants are administered the drug once via intravenous injection.
Phase 1: Participants receive a single, peripheral intravenous (IV) infusion of LY-M003 at de-escalation dose.The dose for de-escalation dose is 2.0 × 10¹³ vg/kg.All participants are administered the drug once via intravenous injection.
Phase 2: Participants receive a single, peripheral intravenous (IV) infusion of LY-M003 at dose group 1.The dose for dose group 1 is 4.0 × 10¹³ vg/kg.All participants are administered the drug once via intravenous injection.
Phase I:The incidence of dose-limiting toxicity (DLT) events adjudicated by the Safety Review Committee (SRC) within at least 28 days after LY-M003 infusion.
The incidence of DLT will be assessed using CTCAE 6.0.
Time frame: Within 28 days after infusion of LY-M003 Injection
The incidence of treatment-emergent adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs) related to LY-M003 within 52 weeks after infusion.
Assessment will be conducted via 12-lead ECG, laboratory tests(blood routine, blood biochemistry, coagulation function, stool routine, urine routine), vital signs (blood pressure, pulse, respiratory rate, body temperature) and physical examination.
Time frame: 5 years
Percentage reduction in the dosage of standard of care (SoC) medications within 52 weeks after administration.
Assessment will be based on the percentage of participants who underwent standard dose reduction after infusion.
Time frame: Within 52 weeks after administration
Number and proportion of subjects who discontinued standard of care (SoC) medications within 52 weeks after administration.
Assessment will be based on the number and percentage of participants who discontinued standard treatment medications.
Time frame: Within 52 weeks after administration
Duration (in treatment weeks) of consecutive discontinuation of SoC medications among the above subjects.
Assessment will be based on the number of consecutive cycles during which participants discontinued standard medications.
Time frame: Within 52 weeks after administration
Change in serum non-caeruloplasmin-bound copper (NCC) from baseline within 52 weeks after administration
Assessment will be based on changes in serum non-ceruloplasmin-bound copper from baseline.
Time frame: Within 52 weeks after administration
Change in serum ceruloplasmin level from baseline within 52 weeks after administration
Assessment will be based on changes in serum ceruloplasmin level from baseline.
Time frame: Within 52 weeks after administration
Change in serum ceruloplasmin activity level from baseline within 52 weeks after administration
Assessment will be based on changes in erum ceruloplasmin activity level from baseline.
Time frame: Within 52 weeks after administration
Change in 24-hour urinary copper content from baseline at each follow-up time point within 52 weeks after administration
Assessment will be based on changes in 24-hour urinary copper content from baseline.
Time frame: Within 52 weeks after administration
Change in serum total copper from baseline within 52 weeks after administration
Assessment will be based on changes in serum total copper from baseline
Time frame: Within 52 weeks after administration
Change from baseline in total score of the neurological subscale of the Unified Wilson's Disease Rating Scale (UWDRS) within 52 weeks after administration
Assess the change from baseline in the total score of Part I of the Unified Wilson's Disease Rating Scale (UWDRS). Part I of the UWDRS is the neurological subscale, with a total score ranging from 0 to 208. Higher scores indicate more severe disease and poorer functional status.
Time frame: Within 52 weeks after administration
Change from baseline in hepatic subscale score of the Unified Wilson's Disease Rating Scale (UWDRS) within 52 weeks after administration
Assess the change from baseline in the total score of Part II of the Unified Wilson's Disease Rating Scale (UWDRS). Part II is the hepatic subscale, with a total score ranging from 0 to 36. Higher scores indicate more severe disease and poorer functional status.
Time frame: Within 52 weeks after administration
Change from baseline in psychiatric subscale score of the Unified Wilson's Disease Rating Scale (UWDRS) within 52 weeks after administration
Assess the change from baseline in the total score of Part III of the Unified Wilson's Disease Rating Scale (UWDRS). Part III is the psychiatric subscale, with a total score ranging from 0 to 76. Higher scores indicate more severe disease and poorer functional status.
Time frame: Within 52 weeks after administration
Change from baseline in individual item/subscale scores (speech, handwriting, standing and gait) of the Unified Wilson's Disease Rating Scale (UWDRS) within 52 weeks after administration
Assessment will be based on changes from baseline in individual item/subscale scores (speech, handwriting, standing and gait) of the Unified Wilson's Disease Rating Scale (UWDRS).The total score for speech, writing, standing and gait each ranges from 0 to 4. Higher scores indicate more severe conditions.
Time frame: Within 52 weeks after administration
Change in ALT and AST from baseline within 52 weeks after administration
Assessment will be based on changes in ALT and AST from baseline
Time frame: Within 52 weeks after administration
Change in liver stiffness from baseline within 52 weeks after administration
Assessment will be based on changes in liver stiffness from baseline.Liver stiffness is measured by liver and gallbladder ultrasonography combined with ultrasound elastography, with the unit of kPa. * \<5.8 kPa: No liver fibrosis (F0) * 5.8 \~ 6.8 kPa: Mild liver fibrosis (F1) * 6.8 \~ 9.1 kPa: Moderate liver fibrosis (F2) * 9.1 \~ 10.3 kPa: Severe liver fibrosis (F3) * \>10.3 kPa: Liver cirrhosis (F4) Higher values indicate more advanced liver fibrosis or cirrhosis.
Time frame: Within 52 weeks after administration
Change in Kayser-Fleischer (K-F) rings from baseline within 52 weeks after administration
Assessment will be based on changes in Kayser-Fleischer (K-F) rings from baseline
Time frame: within 52 weeks after administration
Long-term follow-up study: Percentage reduction in standard of care (SoC) medication dosage after 52 weeks of administration
Assessment will be based on the percentage of participants who underwent standard dose reduction after infusion
Time frame: Weeks 53 to 5 years after LY-M003 infusion
Long-term follow-up study: Number and proportion of subjects who discontinued standard of care (SoC) medications after 52 weeks of treatment
Assessment will be based on the number and percentage of participants who discontinued standard treatment medications.
Time frame: Weeks 53 to 5 years after LY-M003 infusion
Long-term follow-up study: Number of consecutive treatment weeks during which the above-mentioned subjects remained off SoC medications
Assessment will be based on the number of consecutive cycles during which participants discontinued standard medications.
Time frame: Weeks 53 to 5 years after LY-M003 infusion
Long-term follow-up study: Changes in serum ceruloplasmin activity levels from baseline after 52 weeks of treatment
Assessment will be based on changes in erum ceruloplasmin activity level from baseline.
Time frame: Weeks 53 to 5 years after LY-M003 infusion
Long-term follow-up study: Changes in serum ceruloplasmin concentration levels from baseline following 52 weeks of treatment
Assessment will be based on changes in serum ceruloplasmin level from baseline.
Time frame: Weeks 53 to 5 years after LY-M003 infusion
Long-term follow-up study: Changes in non-ceruloplasmin bound copper (NCC) in serum from baseline after 52 weeks of treatment
Assessment will be based on changes in serum non-ceruloplasmin-bound copper from baseline
Time frame: Weeks 53 to 5 years after LY-M003 infusion
Long-term follow-up study: Changes in total serum copper from baseline after 52 weeks of treatment
Assessment will be based on changes in serum total copper from baseline
Time frame: Weeks 53 to 5 years after LY-M003 infusion
Long-term follow-up study: Changes of 24-hour urinary copper levels from baseline at all follow-up visits after 52 weeks of treatment
Assessment will be based on changes in 24-hour urinary copper content from baseline.
Time frame: Weeks 53 to 5 years after LY-M003 infusion
Long-term follow-up study: Changes in quantitative neurological function scores of the Unified Wilson's Disease Rating Scale (UWDRS) from baseline after 52 weeks of treatment
Assess the change from baseline in the total score of Part I of the Unified Wilson's Disease Rating Scale (UWDRS). Part I of the UWDRS is the neurological subscale, with a total score ranging from 0 to 208. Higher scores indicate more severe disease and poorer functional status.
Time frame: Weeks 53 to 5 years after LY-M003 infusion
Long-term follow-up study: Changes in hepatic subscale quantitative scores of the UWDRS from baseline after 52 weeks of treatment
Assess the change from baseline in the total score of Part II of the Unified Wilson's Disease Rating Scale (UWDRS). Part II is the hepatic subscale, with a total score ranging from 0 to 36. Higher scores indicate more severe disease and poorer functional status.
Time frame: Weeks 53 to 5 years after LY-M003 infusion
Long-term follow-up study: Changes in psychiatric symptom subscale quantitative scores of the UWDRS from baseline after 52 weeks of treatment
Assess the change from baseline in the total score of Part III of the Unified Wilson's Disease Rating Scale (UWDRS). Part III is the psychiatric subscale, with a total score ranging from 0 to 76. Higher scores indicate more severe disease and poorer functional status.
Time frame: Weeks 53 to 5 years after LY-M003 infusion
Long-term follow-up study: Changes from baseline in individual item and subscale scores (Speech, Handwriting, Standing and Gait) of the quantitative UWDRS after 52 weeks of treatment
Assessment will be based on changes from baseline in individual item/subscale scores (speech, handwriting, standing and gait) of the Unified Wilson's Disease Rating Scale (UWDRS).The total score for speech, writing, standing and gait each ranges from 0 to 4. Higher scores indicate more severe conditions.
Time frame: Weeks 53 to 5 years after LY-M003 infusion
Long-term follow-up study: Changes in ALT and AST levels from baseline after 52 weeks of treatment
Assessment will be based on changes in ALT and AST from baseline
Time frame: Weeks 53 to 5 years after LY-M003 infusion
Long-term follow-up study: Changes in liver stiffness measurements from baseline after 52 weeks of treatment
Assessment will be based on changes in liver stiffness from baseline.Liver stiffness is measured by liver and gallbladder ultrasonography combined with ultrasound elastography, with the unit of kPa. * \<5.8 kPa: No liver fibrosis (F0) * 5.8 \~ 6.8 kPa: Mild liver fibrosis (F1) * 6.8 \~ 9.1 kPa: Moderate liver fibrosis (F2) * 9.1 \~ 10.3 kPa: Severe liver fibrosis (F3) * \>10.3 kPa: Liver cirrhosis (F4) Higher values indicate more advanced liver fibrosis or cirrhosis.
Time frame: Weeks 53 to 5 years after LY-M003 infusion
Long-term follow-up study: Changes in Kayser-Fleischer (K-F) ring grading from baseline after 52 weeks of treatment
Assessment will be based on changes in Kayser-Fleischer (K-F) rings from baseline
Time frame: Weeks 53 to 5 years after LY-M003 infusion
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Dec 2027, 18 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Hepatolenticular Degeneration →
Lingyi Biotech Co., Ltd.