A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial of ADI-PEG 20 or Placebo in Subjects With Nonalcoholic Steatohepatitis (NASH)

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Evaluate efficacy and safety of ADI-PEG 20 in patients with NASH

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

• Willingness to use appropriate contraceptive measures throughout study treatment and for 90 days thereafter (see Appendix A).

• Body mass index (BMI) \> 23 kg/m2

• Must have confirmation of ≥ 5 % liver fat content on MRI-PDFF at screening.

• 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:

∙ Steatosis (scored 0 to 3),

‣ Ballooning degeneration (scored 0 to 2), and

‣ Lobular inflammation (scored 0 to 3).

• Must have no evidence of worsening of ALT and AST (within 50%) measurements within 2 months prior to screening (-8 weeks) visits.

• Screening laboratory parameters, as determined by the central laboratory:

∙ Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min, as calculated by the Cockcroft- Gault equation;

‣ HbA1c ≤ 9.5% (or serum fructosamine ≤ 381 μmol if HbA1c is unable to be resulted);

‣ Hemoglobin ≥ 11 g/dL;

‣ INR ≤ 1.3, unless due to therapeutic anticoagulation;

‣ Direct bilirubin ≤ 0.5 mg/dL;

‣ Total bilirubin ≤ 1.3 x upper limit of normal (ULN), unless due to an alternate etiology such as Gilbert's syndrome or hemolytic anemia;

‣ Creatinine kinase \< 3 x ULN;

‣ Platelet count ≥ 150,000/μL;

‣ Serum triglyceride level ≤ 500 mg/dL;

∙ ALT \< 6 x ULN;

∙ AST \< 6 x ULN;

∙ ALP \< 2 x ULN.

• FibroScan® measurement \> 7.0 kPa and \< 20.0 kPa.

• 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.

⁃ Subjects on vitamin E and pioglitazone must maintain a stable dosage before the diagnostic liver biopsy and during the study period.

Locations
Other Locations
Taiwan
Ditmanson Medical Foundation Chiayi Christian Hospital;Chiayi Christian Hospital (CYCH)
RECRUITING
Chiayi City
Chang Gung Medical Foundation-Kaohsiung (CGMF-KS)
RECRUITING
Kaohsiung
E-Da Hospital (EDH)
RECRUITING
Kaohsiung
Kaohsiung Medical University Chung-Ho Memorial Hospital(KMUH)
RECRUITING
Kaohsiung
Chang Gung Medical Foundation-Keelung (CGMF-KL)
RECRUITING
Keelung
National Cheng Kung University Hospital (NCKUH)
RECRUITING
Tainan City
Fu Jen Catholic University Hospital (FJCUH)
RECRUITING
Taipei
National Taiwan University Hospital (NTUH)
RECRUITING
Taipei
Taipei Veterans General Hospital (TPVGH)
RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou (CGMF-LK)
RECRUITING
Taoyuan District
Contact Information
Primary
Silvia Lee
silvialee@polarispharma.com
02-2656-2727
Time Frame
Start Date: 2023-09-13
Estimated Completion Date: 2028-01-31
Participants
Target number of participants: 60
Treatments
Experimental: Drug: ADI-PEG 20
Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM)
Placebo_comparator: Drug: Placebo
Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM)
Sponsors
Leads: Polaris Group

This content was sourced from clinicaltrials.gov