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

NCT02498275 | Terminated

• 1 other identifier: YP29018
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (3)

• Correlation coefficients between baseline toll-like receptor 7 (TLR7) expression and ex vivo immune response upon stimulation of PBMCs with RO6871765 or RO7011785 (in terms of cytokine release and gene expression)

  Day 1

• Cytokine/chemokine production

  Day 1

• Induction of interferon-responsive genes

  Day 1

Secondary Outcomes (6)

• Number or percentages of T-lymphocytes in healthy volunteers and subjects with CHB

  Screening Up to Day 1

• Number or percentages of B-lymphocytes in healthy volunteers and subjects with CHB

  Screening up to Day 1

• Number or percentages of natural killer (NK) -cells in healthy volunteers and subjects with CHB

  Screening up to Day 1

• Number or percentages of myeloid dendritic cells (mDCs) in healthy volunteers and subjects with CHB

  Screening up to Day 1

• Number or percentages of plasmacytoid dendritic cells (pDCs) in healthy volunteers and subjects with CHB

  Screening up to Day 1

Study Arms (3)

Healthy volunteers

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

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

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese population: healthy volunteers, treatment naive CHB patients and nucleoside or nucleotide analogue treated CHB patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (3)

Unknown Facility

Shanghai, 200025, China

Location

Unknown Facility

Shanghai, 200433, China

Location

Unknown Facility

Shanghai, 201203, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 15, 2015
• Study Start: July 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 7, 2016

Record last verified: 2016-11

Locations

CN (3)