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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 | Clinical Trials | Clareo Health

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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•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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
+3 more criteria

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

Locations (3)

Shanghai, China

Key Dates

Start Date

July 1, 2014

Primary Completion Date

August 1, 2014

Completion Date

August 1, 2014

Last Updated

November 7, 2016

Enrollment

ACTUAL participants

Conditions

Hepatitis B, Chronic

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

NCT04166266

Hepatitis D, ChronicHepatitis B, Chronic

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RECRUITING

Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion

NCT06550622

Hepatitis B, Chronic

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RECRUITINGEARLY_PHASE1

Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 7, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion

Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection

Effectiveness of Antiviral Treatment in Cirrhotic Patients with Low-level Hepatitis B Virus DNA Levels