Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal Antibody

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to assess safety and efficacy of multiple doses of NI-0801 in primary biliary cirrhosis patients with an inadequate response to ursodeoxycholic acid.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1

NCT04618575

Hepatitis Primary Biliary Cholangitis Autoimmune

UNKNOWN PHASE4

Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients

NCT05292872

Primary Biliary Cholangitis

COMPLETED

A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients

NCT05293938

Primary Biliary Cholangitis

WITHDRAWN

A Study of CS0159 in Patients With PBC With Inadequate Response or Intolerance to UDCA

NCT07282353

Primary Biliary Cholangitis

RECRUITING PHASE3

A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis

NCT02932449

Biliary Cirrhosis, Primary

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Biliary Cirrhosis

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NI-0801

Group Type EXPERIMENTAL

NI-0801

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NI-0801

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Proven primary biliary cirrhosis (PBC), as demonstrated by the presence of at least 2 of the following 3 diagnostic factor (History of increased alkaline phosphatase levels for at least 6 months; positive serum AMA titer; Liver biopsy consistent with PBC)
* Elevated liver enzyme levels at screening
* Have given written informed consent

Exclusion Criteria

* Screening bilirubin \> 2.9 mg/dL (50 μmol/L)
* Screening creatinine clearance \< 80 ml/min
* History or presence of hepatic decompensation (e.g., esophageal variceal bleeding, hepatic encephalopathy, or ascites)
* Positive serology result for Human Immunodeficiency Virus (HIV), Hepatitis B or C
* Known or previous diagnosis of malignancy
* Presence of any active infection
* Previous history of active TB within 12 months of screening

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No