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The Relationship Between MDSCs and NK Cells Activity of CHC Patient Treated by DAAs | Clinical Trials | Clareo Health

COMPLETEDEARLY_PHASE1

The Relationship Between MDSCs and NK Cells Activity of CHC Patient Treated by DAAs

The Relationship Between Direct Acting Antiviral Treatment Effect and Myeloid-Derived Suppressor Cells and NK Cells Activity in Chronic Hepatitis C

NCT03188276•Third Affiliated Hospital, Sun Yat-Sen University

View on ClinicalTrials.gov

Summary

Hepatitis C virus (HCV) infection is easy to chronic and can progress to cirrhosis and liver cancer. Direct-acting antiviral treatment can significantly improve the prognosis of the disease and the efficacy is seemingly not affected by a variety of viral factors. In addition, direct-acting antiviral agents therapy may affect the transformation of the immune cells and ameliorate the host immune status consequently. This study mainly investigated the relationship between Direct Acting Antiviral Treatment effect and the functional activity of myeloid-derived suppressor cells (MDSCs) and natural killer cells (NK cells) in Chronic Hepatitis C.

Detailed Description

32 treatment-naive CHC patients and 20 healthy controls were recruited. Patients were examined before DAAs therapy (0w) and at weeks 4 (4w) and weeks 12 (12w) and weeks24 (24w) of the therapy. The percent age of myeloid-derived suppressor cells and NK cells of the peripheral blood were analyzed by flow cytometry. The investigators discuss the relationship between direct acting antiviral treatment effect and myeloid-derived suppressor cells and NK cells activity in chronic hepatitis C.

Eligibility

Age

18 - 76 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Positive serum Anti-HCV antibody or serum HCV-RNA, CHC patients without any treatment

Exclusion Criteria

•Patient has a history of clinical signs/symptoms of hepatic decompensation (Child-Pugh Grade B or C) or ascites, esophageal variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis.
•Patient has a history of hepatocellular carcinoma (HCC) or suspected symptoms of HCC, such as suspicious foci on imaging studies and/or serum alpha-fetoprotein (AFP)\>50ng/mL.
•Patient has received IFN or other immunomodulatory treatment within 52 weeks before Screening.
•Patient has a medical condition that requires frequent use of systemic acyclovir or famciclovir.
•Patient has a medical condition that requires frequent use of systemic corticosteroids, however topical and inhaled corticosteroids are allowed.
•Patient has used hepatotoxic drugs within one month. Patient has overtaken alcohol (\>40g/day) or abused illicit drugs in recent one year.
•Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test.
•Patients who co-infected with HAV, HBV, HDV, HEV,HIV(human immunodeficiency virus ) Patient has one or more additional known primary or secondary causes of liver disease, other than hepatitis C (e.g., alcoholism, autoimmune hepatitis).
•History of malignancy of any organ system.

Key Dates

Start Date

February 1, 2016

Primary Completion Date

May 1, 2017

Completion Date

May 1, 2017

Last Updated

June 15, 2017

Enrollment

ACTUAL participants

Conditions

Chronic Hepatitis C

Interventions

Ledipasvir-Sofosbuvir

DRUG

Daclatasvir-Sofosbuvir

DRUG

Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

NCT00199719

Chronic Hepatitis C

View study

COMPLETEDPHASE4

Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital

NCT06922643

Chronic Hepatitis C

View study

COMPLETEDNA

Changes in Liver Fibrosis, Lipid Profile and Insulin Resistance in HCV Patients Who Received Antiviral Therapy

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: June 15, 2017Data 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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The Relationship Between MDSCs and NK Cells Activity of CHC Patient Treated by DAAs

Inclusion Criteria

Exclusion Criteria

Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital

Changes in Liver Fibrosis, Lipid Profile and Insulin Resistance in HCV Patients Who Received Antiviral Therapy

Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV

Treatment of HCV-Infected Recent Injection Drug Users in U.S. Liver Clinics

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection