[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Polaris Group\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100463678","phase-3-study-of-adi-peg-20-versus-placebo-in-subjects-with-high-arginine-level-and-unresectable-hepatocellular-carcinoma-100463678",false,"NCT05317819","Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma","A Randomized, Double-Blind, Multi-Center Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Prior diagnosis of HCC confirmed by radiology, histology, or cytology.\n2. Prior treatment with at least 1 systemic agent for Child-Pugh A subjects. However, Child-Pugh B7 subjects without prior systemic treatment may be enrolled, if they are not eligible for any approved systemic therapies (e.g., due to financial factors).\n3. Plasma arginine ≥ 78 μM at pre-screening visit.\n4. Measurable disease using RECIST 1.1 (Appendix A). At least 1 measurable lesion must be present. Subjects who have received local-regional therapies are eligible, provided that they have either a target lesion which has not been treated with local therapy and\u002For the target lesion(s) within the field of the local regional therapy has shown an increase of ≥ 20% in size. Local-regional therapy must be completed at least 4 weeks prior to the baseline CT scan.\n5. Child-Pugh (cirrhosis status) score class A-B7 (Appendix C).\n6. Barcelona Cancer of the Liver (BCLC) stage C (Appendix B)\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment (Appendix D).\n8. Expected survival of at least 3 months.\n9. Age \\>18 years.\n10. Fully recovered from prior surgery, radiation, or chemotherapy, and none within 2 weeks prior to week 1 visit. Liver biopsy for HCC confirmation is allowed.\n11. Female subjects and male subjects must be asked to use appropriate contraception for both the male and female for the duration of the study and for 35 days after last dose of ADI-PEG 20\u002Fplacebo. Male partners of female subjects and female partners of male subjects must agree to use two forms of contraception or agree to refrain from intercourse for the duration of the study if they are of childbearing potential. Females of childbearing potential must not be pregnant at the start of the study, and a serum human chorionic gonadotropin (HCG) pregnancy test must be negative before entry into the study. If positive HCG pregnancy test, further evaluation to rule out pregnancy must be performed according to GCP before this subject is deemed eligible. Females not of childbearing potential must be post-menopausal (defined as cessation of regular menstrual period for at least 12 months).\n12. Informed consent must be obtained prior to study initiation.\n13. No concurrent investigational studies are allowed.\n14. Total bilirubin \\\u003C 3.0 mg\u002FdL and no evidence of bile obstruction.\n15. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 x upper limit of normal range.\n16. Serum albumin level ≥ 3.0 g\u002Fdl.\n17. Prothrombin time (PT)-international normalized ratio (INR): PT \\\u003C3 seconds above control or INR \\\u003C1.7.\n18. Absolute neutrophil count (ANC) \\>1,500\u002FµL.\n19. Platelets \\>50,000\u002FµL.\n20. Serum uric acid ≤ 8 mg\u002FdL (with or without medication control).\n21. Serum creatinine ≤ 1.5 x the upper limit of normal range, or, if serum creatinine \\>1.5 x the upper limit of normal range, then the creatinine clearance must be ≥ 40 mL\u002Fmin.\n22. Subjects with active hepatitis B or C on anti-viremic compounds may remain on such treatment, except for interferon.\n23. Encephalopathy - none or mild (grade 1 or 2, by Child-Pugh classification); lactulose of other supportive care allowed.\n24. Ascites - absent or slight (by Child-Pugh classification); diuretic therapy allowed.\n\nExclusion Criteria:\n\n1. Candidate for potential curative therapies (i.e., resection or transplantation) or eligible for approved systemic therapies according to the labeling of such drugs.\n2. Prior allograft transplantation including liver transplantation.\n3. Subjects who have not fully recovered from toxicities associated with previous HCC loco-regional or systemic therapies, except for Grade 1 alopecia.\n4. Serious infection requiring treatment with intravenous, systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment.\n5. Pregnancy or lactation.\n6. Expected non-compliance.\n7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), cardiac arrhythmia, or psychiatric illness, social situations that would limit compliance with study requirements.\n8. Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present or in the opinion of the investigator will not affect patient outcome.\n9. Subjects who had been treated with ADI-PEG 20 previously.\n10. History of uncontrolled seizure disorder not related to underlying cancer.\n11. Allergy to pegylated compounds.\n12. Allergy to E. coli drug products (such as GMCSF).\n13. Bleeding esophageal or gastric varices within the prior three months, except if banded or treated.\n14. Uncontrolled ascites (defined as not easily controlled with diuretic treatment).\n15. Having received any blood transfusion, blood component preparation, erythropoietin, albumin preparation, or granulocyte colony stimulating factors (G-CSF) within 7 days prior to screening laboratories or after screening laboratories have been obtained until week 1 visit.\n16. Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.","ALL","18 Years","99 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Evaluate efficacy and safety of ADI-PEG 20 in patients with high-argininephenotypic and HCC",[27,28],"Hepatocellular Carcinoma","Advanced Hepatocellular Carcinoma",[30,31,32,33,34,35],"Unresectable Hepatocellular Carcinoma","Genotype","Arginine","Arginine Deiminase","ADI-PEG 20","pegargiminase","RECRUITING","2025-12-10",{"date":39,"type":40},"2025-12-18","ACTUAL",{"date":42,"type":40},"2022-03-14",{"date":44,"type":21},"2028-12",{"name":46,"class":47},"Polaris Group","INDUSTRY",11,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100503995","phase-2-study-of-adi-peg-20-versus-placebo-in-subjects-with-nash-100503995","NCT05842512","Study of ADI-PEG 20 Versus Placebo in Subjects With NASH","A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial of ADI-PEG 20 or Placebo in Subjects With Nonalcoholic Steatohepatitis (NASH)","Inclusion Criteria:\n\n1. Males and non-lactating, pregnancy test negative females between 18 - 80 years of age with biopsy proven F1 - F4 (compensated cirrhosis, Child-Pugh A, score ≤6) NASH. Limit F1 fibrosis to ≤ 20% of total subject population.\n2. Willingness to use appropriate contraceptive measures throughout study treatment and for 90 days thereafter (see Appendix A).\n3. Body mass index (BMI) \\> 23 kg\u002Fm2\n4. Must have confirmation of ≥ 5 % liver fat content on MRI-PDFF at screening.\n5. Biopsy-proven NASH confirmed by a central pathologist. Must have had a liver biopsy either during the screening period or a historical biopsy conducted within the last 6 months prior to pre-screening with fibrosis stage 1 to 4 (F score, F1-F4) and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:\n\n   1. Steatosis (scored 0 to 3),\n   2. Ballooning degeneration (scored 0 to 2), and\n   3. Lobular inflammation (scored 0 to 3).\n6. Must have no evidence of worsening of ALT and AST (within 50%) measurements within 2 months prior to screening (-8 weeks) visits.\n7. Screening laboratory parameters, as determined by the central laboratory:\n\n   1. Estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin, as calculated by the Cockcroft- Gault equation;\n   2. HbA1c ≤ 9.5% (or serum fructosamine ≤ 381 μmol if HbA1c is unable to be resulted);\n   3. Hemoglobin ≥ 11 g\u002FdL;\n   4. INR ≤ 1.3, unless due to therapeutic anticoagulation;\n   5. Direct bilirubin ≤ 0.5 mg\u002FdL;\n   6. Total bilirubin ≤ 1.3 x upper limit of normal (ULN), unless due to an alternate etiology such as Gilbert's syndrome or hemolytic anemia;\n   7. Creatinine kinase \\\u003C 3 x ULN;\n   8. Platelet count ≥ 150,000\u002FμL;\n   9. Serum triglyceride level ≤ 500 mg\u002FdL;\n   10. ALT \\\u003C 6 x ULN;\n   11. AST \\\u003C 6 x ULN;\n   12. ALP \\\u003C 2 x ULN.\n8. FibroScan® measurement \\> 7.0 kPa and \\\u003C 20.0 kPa.\n9. Subjects on non-insulin dependent diabetic, weight loss, or lipid-modifying medication(s) must be on stable dose(s) for at least 3 months prior to the diagnostic liver biopsy through randomization.\n10. Subjects on vitamin E and pioglitazone must maintain a stable dosage before the diagnostic liver biopsy and during the study period.\n\nExclusion Criteria:\n\n1. Weight gain or loss \\> 5% in the 3 months prior to randomization or \\> 10% in the 6 months prior to screening.\n2. Type 1 and insulin-dependent Type 2 diabetes.\n3. Poorly controlled hypertension (blood pressure \\[BP\\] \\> 160\u002F100 mmHg).\n4. Prior history of decompensated liver disease including ascites, hepatic encephalopathy (HE), or variceal bleeding.\n5. Chronic hepatitis B virus (HBV) infection (hepatitis B surface antigen \\[HBsAg\\] positive.\n6. Chronic hepatitis C virus (HCV) infection (HCV antibody \\[Ab\\] and HCV ribonucleic acid \\[RNA\\] positive). Subjects cured of HCV infection less than 1 year prior (based on date of RNA polymerase chain reaction \\[PCR\\] negative confirmation following conclusion of treatment) to the screening visit are not eligible.\n7. Prior or planned (during the study period) bariatric surgery (e.g., gastroplasty, roux-en-Y gastric bypass), surgery reversal or removal of intragastric balloon \\> 2 years prior to enrollment would be eligible.\n8. Other causes of liver disease based on medical history and\u002For centralized review of liver histology, including but not limited to alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis \\[PBC\\], primary sclerosing cholangitis \\[PSC\\], autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency requiring treatment.\n9. History of liver transplantation.\n10. Subjects with primary cancer, including co-existent second malignancy, with the exception of primary solid tumor with no known active disease present in the opinion of the Investigator which will not affect subject outcome in the setting of current diagnosis.\n11. Alcohol intake above an average limit of 2 drinks per day for women and 3 drinks per day for men. An alcoholic drink is defined as 12 ounces of regular beer, which is usually about 5% alcohol, 5 ounces of wine, which is typically about 12% alcohol, and 1.5 ounces of distilled spirits, which is about 40% alcohol.\n12. Human immunodeficiency virus (HIV) infection.\n13. Unstable cardiovascular disease in the 6 months prior to screening.\n14. Life expectancy less than 2 years.\n15. Use of any investigational medication within 30 days or within 5 half-lives of the investigational medication, whichever is longer, prior to screening and throughout the study is prohibited.\n16. Subjects with a history of (12 months prior to baseline) or current use of prescription drugs associated with liver steatosis (e.g., methotrexate, amiodarone, high-dose estrogen, tamoxifen, systemic steroids, anabolic steroids, valproic acid) should be excluded. However, subjects currently using silymarin should maintain their current dosage throughout the trial period.\n17. Contraindication of magnetic resonance imaging. These include but are not limited to devices or metal foreign bodies, such as Pacemaker, defibrillator or wires other than sternal wires, metallic foreign body in the eye, \"triggerfish\" contact lens, gastric reflux device, and insulin pumps.\n18. MELD score \\>12\n19. Subjects with esophageal or gastric varices with recent bleeding episodes (within 1 year).","80 Years",{"count":58,"type":21},60,[60],"PHASE2","Evaluate efficacy and safety of ADI-PEG 20 in patients with NASH",[63],"Nonalcoholic Steatohepatitis (NASH)",[63,32,33,34,65],"Pegargiminase","2025-09-18",{"date":68,"type":40},"2025-09-23",{"date":70,"type":40},"2023-09-13",{"date":72,"type":21},"2028-01-31",{"name":46,"class":47},10,""]