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Hepatitis B, ChronicNCT02498275

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

An observational study of Hepatitis B, Chronic, run by Hoffmann-La Roche at 3 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Hepatitis B, Chronic
How many people
14 participants
Where
3 sitesChina
Study dates
Jul 2014to Aug 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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 locations and contacts

3 sites in 1 country.

China3 sites

  • Study site

    Shanghai, 200025

  • Study site

    Shanghai, 200433

  • Study site

    Shanghai, 201203

Other trials in China

About this study

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.

Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02498275
Study groupRoleWhat they receive
Healthy volunteersBlood samples from healthy volunteers will be collected for ex vivo stimulation and for further sample preparation and analysis.
Nucleoside/nucleotide analogue-treated CHB patientsBlood 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 patientsBlood samples from treatment-naïve CHB patients will be collected for ex vivo stimulation and for further sample preparation and analysis.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Day 1

  2. Cytokine/chemokine production

    Measured: Day 1

  3. Induction of interferon-responsive genes

    Measured: Day 1

Secondary outcomes (6)

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

    Measured: Screening Up to Day 1

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

    Measured: Screening up to Day 1

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

    Measured: Screening up to Day 1

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

    Measured: Screening up to Day 1

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

    Measured: Screening up to Day 1

  6. Ex-vivo antiviral activity of PBMC supernatant

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2015 (estimated)
  2. Study startJul 2014
  3. Primary completionAug 2014
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02498275
Sponsor's protocol ID
YP29018
Status last verified
Nov 2016
First submitted
13 Jul 2015
Last updated
7 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis B, Chronic, run by Hoffmann-La Roche at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02498275.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2016.

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