Active — Not RecruitingPhase 2

CS0159 in Chinese Patients With PBC (Primary Biliary Cholangitis)

China75 participantsStarted 2023-08-07

Plain-language summary

A phase II study to evaluate safety, tolerability and efficacy of CS0159 in patients with PBC (Primary Biliary Cholangitis).

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. When signing ICF age≥18 years≤75 years, male or female
✓. Meets the diagnostic criteria of PBC, such as elevation ALP, positive AMA or AMA-M2, If negative for AMA, positive for PBC specific antibody and Liver biopsy meeting PBC criteria six months before screening
✓. 1.67 × ULN ≤ALP ≤ 10 × ULN and TBil≤ 3 × ULN
✓. UDCA≥6 months before randomization and a stable dose (no less than 13-15 mg/kg/d in principle) ≥3 months after the efficacy was poor (meeting inclusion criteria 3), or UDCA was not tolerated, and stop taking UDCA (no UDCA use for ≥3 months before randomization)
✓. Understand the study content, comply with the study protocol, and sign the ICF voluntarily

✕. ALT or AST\>5×ULN；
✕. OCA(Obercholic acid) in the 3 months prior to randomization
✕. Known concomitant hepatobiliary disease or history
✕. Significant hepatic impairment as defined by Child-Pugh classification of B or C, history of liver transplantation, current placement on a liver transplant list or current Model for End Stage Liver Disease (MELD) score ≥15.
✕. Patients were screened for HBsAg positive, HCVAb positive, HIV Ab positive, or TPAb positive.
✕. (creatinine, Cr) ≥1.5×ULN and Cr clearance rate \<60 mL/min
✕. Platelet\<80×10\^9/L；
✕. INR\>1.3

AE incidence

Timeframe: baseline to 12 weeks

relative changes from baseline in ALP at week 12

Timeframe: baseline to 12 weeks

NCT IDNCT05896124

SponsorCascade Pharmaceuticals, Inc

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. When signing ICF age≥18 years≤75 years, male or female
✓. Meets the diagnostic criteria of PBC, such as elevation ALP, positive AMA or AMA-M2, If negative for AMA, positive for PBC specific antibody and Liver biopsy meeting PBC criteria six months before screening
✓. 1.67 × ULN ≤ALP ≤ 10 × ULN and TBil≤ 3 × ULN
✓. UDCA≥6 months before randomization and a stable dose (no less than 13-15 mg/kg/d in principle) ≥3 months after the efficacy was poor (meeting inclusion criteria 3), or UDCA was not tolerated, and stop taking UDCA (no UDCA use for ≥3 months before randomization)
✓. Understand the study content, comply with the study protocol, and sign the ICF voluntarily

✕. ALT or AST\>5×ULN；
✕. OCA(Obercholic acid) in the 3 months prior to randomization
✕. Known concomitant hepatobiliary disease or history
✕. Significant hepatic impairment as defined by Child-Pugh classification of B or C, history of liver transplantation, current placement on a liver transplant list or current Model for End Stage Liver Disease (MELD) score ≥15.
✕. Patients were screened for HBsAg positive, HCVAb positive, HIV Ab positive, or TPAb positive.
✕. (creatinine, Cr) ≥1.5×ULN and Cr clearance rate \<60 mL/min
✕. Platelet\<80×10\^9/L；
✕. INR\>1.3