Hepatitis C Clinical Trial
Official title:
Impact of Immune Responses in Chronic Hepatitis C Genotype 1,2,3 Virus Infected Patients During Treatment With Pegylated Interferon-alpha-2b and Ribavirin (CIRES).
Aim
To evaluate the effects of peginterferon and ribavirin therapy on the immune response in
chronic HCV genotype 1,2 or 3 patients before, during and after treatment.
Background
Treatment of chronic hepatitis C (HCV) has shown a remarkable success. However, genotype 1
patients have reduced response rates. A better understanding and improvement of these
results can now be considered the greatest challenge.
In chronically infected patients, HCV-specific immune responses are generally weak, narrowly
focused, and often dysfunctional. The presence of HCV-specific cells suppressing the immune
response (regulatory T-lymphocytes=Treg) are able to suppress the immune response. These
Treg are possibly responsible for the impaired immune response.
Previous studies have indicated increased Treg frequency and activity of immune regulating
mechanisms, locally in the liver, as a result of HCV re-infection. Hence, these Data
highlight the importance of monitoring intrahepatic immune responses in addition to
peripheral immune responses. Using the minimally-invasive technique of fine-needle
aspiration biopsy (FNAB), it is now possible to obtain safe and frequent liver samples to
monitor local antiviral immune responses in chronic HCV patients during antiviral therapy.
Rationale and hypothesis of the study
Our previous studies and current literature support the concept that Treg may contribute to
HCV persistence by suppressing HCV-spec immune responses. The current study is designed to
examine if peginterferon and ribavirin therapy affects the activity of Treg and DC, and if
this results in enhanced HCV-specific immune responses.
Design
Single centre, translational and observational open label study with one arm of 20 genotype
1 patients and one arm of 7 genotype 2/3 patients.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
| Recruiting |
NCT04510246 -
Link Hepatitis C Notifications to Treatment in Tasmania
|
N/A | |
| Completed |
NCT03413696 -
Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
|
||
| Completed |
NCT03118674 -
Harvoni Treatment Porphyria Cutanea Tarda
|
Phase 2 | |
| Completed |
NCT03109457 -
Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma
|
||
| Completed |
NCT01458054 -
Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults
|
Phase 1 | |
| Completed |
NCT03740230 -
An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs
|
||
| Completed |
NCT03426787 -
Helping Empower Liver and Kidney Patients
|
N/A | |
| Completed |
NCT03627299 -
Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors
|
Phase 4 | |
| Completed |
NCT00006301 -
Immune Response to Hepatitis C Virus
|
||
| Active, not recruiting |
NCT03949764 -
The Kentucky Viral Hepatitis Treatment Study
|
Phase 4 | |
| Completed |
NCT03365635 -
Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C
|
Phase 4 | |
| Recruiting |
NCT04405024 -
Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients
|
N/A | |
| Completed |
NCT04525690 -
Improving Inpatient Screening for Hepatitis C
|
N/A | |
| Completed |
NCT04033887 -
Evaluation Study of RDTs Detecting Antibodies Against HCV
|
||
| Withdrawn |
NCT04546802 -
HepATocellular Cancer Hcv Therapy Study
|
Phase 3 | |
| Active, not recruiting |
NCT02961426 -
Strategic Transformation of the Market of HCV Treatments
|
Phase 2/Phase 3 | |
| Completed |
NCT02705534 -
Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1
|
Phase 3 | |
| Completed |
NCT02992184 -
PoC-HCV Genedrive Viral Detection Assay Validation Study
|
N/A | |
| Completed |
NCT02683005 -
Study of Hepatitis C Treatment During Pregnancy
|
Phase 1 |