Effect of RO6871765 and RO7011785 on Immune Response With the Stimulation of Peripheral Blood Mononuclear Cells (PBMCs) in Chinese Healthy Volunteers and Chronic Hepatitis B Patients

Roche

Status: Terminated

Conditions: Hepatitis B, Chronic

Study type: Observational

Funder types: Industry

Identifiers

NCT02498275

YP29018

Details and patient eligibility

About

This is an exploratory study to characterize the ex vivo immune response to RO6871765 or RO7011785 stimulation of peripheral blood mononuclear cells (PBMCs) extracted from healthy volunteers and chronic hepatitis B (CHB) patients.

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

All population:

• Chinese population
• Adequate hematological function: platelet count greater than or equal to (>=) 100*10^9 per liter (/L), hemoglobin (Hb) >= 12 grams/deciliter (g/dL) (male) or >= 11 g/dL (female), white blood cell (WBC) count >= 4*10^9/L and <= 11*10^9/L

Healthy volunteers:

• Absence of evidence of any active or chronic disease
• Negative hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B envelope antigen (HBeAg), hepatitis B envelope antiody (HBeAb) and hepatitis B core antibody (HBcAb)
• Adequate liver function: transaminases alanine aminotransferase (ALT) <= 1.0 times the upper limit of normal (ULN)

Treatment naïve CHB patients:

• HBsAg-positive (>=250 international unit/milliliter [IU/mL]), compensated liver function, non-cirrhotic
• HBeAg-positive, HBV DNA >= 200,000 IU/ml or equivalent copies/mL, ALT >1.5 times the ULN and ALT <8 times the ULN

HBeAg-negative nucleoside/nucleotide analogue-treated CHB patients:

• Subjects who HBeAg-seroconverted on nucleoside/nucleotide analogue therapy (treatment for 1 to 3 years prior to enrollment) with HBV DNA <90 IU/mL or below a detection level acceptable by both the sponsor and investigator for at least the preceding 6 months; HBeAg negative and HBeAb positive
• HBsAg-positive (>=250 IU/mL), compensated liver function, non-cirrhotic -ALT <= 1*ULN

Exclusion criteria

• Use of steroids or other immune suppressive agents within the last 4 weeks that would impact the number/functions of white blood cells (WBC)
• Any other diseases or clinical laboratory finding giving reasonable suspicion of a disease or condition (including, but not limited to, cancer, lupus erythematosus, rheumatoid arthritis, or other autoimmune disease) that could confound the result of the study
• Positive Hepatitis A immunoglobulin M (IgM) antibody, Hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV) at screening
• Significant acute infection, example; influenza, acute gastrointestinal symptoms or any other clinically significant illness within 2 weeks
• Previous/concurrent treatment with interferon-based therapy for CHB

Trial design

14 participants in 3 patient groups

Healthy volunteers

Description:

Blood samples from healthy volunteers will be collected for ex vivo stimulation and for further sample preparation and analysis.

Nucleoside/nucleotide analogue-treated CHB patients

Description:

Blood samples from nucleoside/nucleotide analogue-treated CHB patients will be collected for ex vivo stimulation and for further sample preparation and analysis.

Treatment-naive CHB patients

Description:

Blood samples from treatment-naïve CHB patients will be collected for ex vivo stimulation and for further sample preparation and analysis.