Study to Assess Monoclonal B-Cell Lymphocytosis in Individuals With Chronic Hepatitis C

A Prospective Observational Study to Assess Monoclonal B-Cell Lymphocytosis in Individuals With Chronic Hepatitis C

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06564051

Enrollment

Registered

2024-08-21

Start date

2017-11-14

Completion date

2025-12-03

Last updated

2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Viral Hepatitis C, Monoclonal B-Cell Lymphocytosis

Brief summary

This study evaluates the incidence of monoclonal B-cell lymphocytosis MBL) in patients with chronic hepatitis C and to determine if monoclonal b-cell lymphocytosis is affected by treatment for hepatitis C.

Detailed description

PRIMARY OBJECTIVES: I. To determine the prevalence of MBL in patients with chronic hepatitis C who are to begin therapy with directly acting antiviral (DAA), and compare with clinic controls who are seen in the general medicine clinic at Mayo Clinic. II. To determine the correlation between the specific subtype of MBL (CD5- MBL, atypical CLL-phenotype MBL and CLL-phenotype MBL) relative to the hepatitis C virus (HCV) genotype. III. To assess the proportion of individuals with MBL who have an improvement in the circulating monoclonal B-cell population following therapy with DAA. OUTLINE: This is an observational study. Patients undergo blood sample collection and have medical records reviewed throughout study.

Interventions

OTHERNon-Interventional Study

Non-interventional study

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Individuals with chronic hepatitis C who are to begin therapy with DAA * Willing to submit a peripheral blood sample at baseline, end of therapy, 12 weeks after the end of therapy, and 52 weeks from baseline

Exclusion criteria

* Individuals with chronic hepatitis C who have cirrhosis * Individuals with chronic hepatitis C who have a past history of a lymphoproliferative disorder AND for which they received chemotherapy

Design outcomes

Primary

Measure	Time frame	Description
Prevalence of monoclonal B-cell lymphocytosis (MBL)	Baseline; up to one year	Blood samples collected in conjunction with routine clinical blood draws will be tested for MBL and compared with post-therapy samples and with control patients (without hepatitis C).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026