Status:
COMPLETED
A Study of Cetrelimab in Participants With Chronic Hepatitis B Virus Infection
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to characterize the pharmacokinetic (PK) profile of cetrelimab administered subcutaneous (SC) and optionally intravenous (IV) in chronic hepatitis B (CHB) participants.
Detailed Description
Hepatitis B virus (HBV) is a small deoxyribonucleic acid (DNA) virus that infects the liver and can cause either acute (less than 6 months) or chronic (more than 6 months) infection. Persistence of HB...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Must have chronic hepatitis B virus (HBV) infection documented
- Participants should be virologically suppressed, Hepatitis Be antigen (HBeAg) status (positive or negative) be on stable Nucleotide analog (NA) treatment for at least 6 months
- Must have: a) A liver biopsy result classified as Metavir F0-F2 within 2 years prior to screening; b) If a liver biopsy result is not available: Fibroscan liver stiffness measurement less than or equal to (\<=) to 9.0 kilopascals (kPa) within 6 months prior to screening or at the time of screening
- Must be medically stable
- Must have a body mass index (weight in kilogram \[kg\] divided by the square of height in meters) between 18.0 and 30.0 kilograms per meter square (kg/m\^2), extremes included
- Exclusion Criteria
- History or evidence of clinical signs or symptoms of hepatic decompensation, including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices
- Participants with evidence of liver disease of non-HBV etiology.
- Participants with history or signs of cirrhosis or portal hypertension (nodules, no smooth liver contour, no normal portal vein, spleen size greater than or equal to \[\>=\] 12 centimeters) or signs of hepatocellular carcinoma (HCC) on an abdominal ultrasound performed within 6 months prior to screening or at the time of screening
- History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
Exclusion
Key Trial Info
Start Date :
April 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT05242445
Start Date
April 19 2022
End Date
May 9 2023
Last Update
July 24 2023
Active Locations (13)
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1
SGS Belgium NV
Edegem, Belgium, 2650
2
Az Sint-Maarten
Mechelen, Belgium, 2800
3
Hopital Beaujon
Clichy, France, 92110
4
APHP - Hopital Henri Mondor
Créteil, France, 94010