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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

NCT ID: NCT02498275

Last Updated: 2016-11-07

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

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Recruitment Status

TERMINATED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis B, Chronic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy volunteers

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

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Shanghai, , China

Site Status

Shanghai, , China

Site Status

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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YP29018

Identifier Type: -

Identifier Source: org_study_id