Chronic Hepatitis C Virus Infection Clinical Trial
Official title:
FGL2/Fibroleukin and Hepatitis C Virus Infection: A Predictor of Response to Antiviral Therapy
The main objective of this study is to assess whether a recently-developed bioassay for the protein FGL2 can be used to predict the progression and/or response to treatment of Hepatitis C Virus disease in patients with chronic HCV infection. The hypothesis is that increased levels of FGL2 and increased numbers of T regulatory cells are associated with a failure to respond to treatment.
The current therapy for chronic Hepatitis C Virus infection leads to a sustained viral
response in only 50% of treated patients. Evidence suggests that a poor response to
treatment may be the result of a dysfunction of immunoregulatory mediators including T
regulatory cells (Tregs) which secrete FGL2. The aim of this study is to test whether serum
FGL2 levels can serve as a biomarker for clinical progress and treatment response in
patients undergoing anti-viral therapy for chronic HCV infection.
This study will measure the blood Treg and FGL2 levels of patients with chronic Hepatitis C
as they undergo antiviral therapy and will compare those levels to their pre-treatment and
post-treatment levels. Treg and FGL2 expression levels will also be measured in patients'
liver biopsy tissue when available.
Additionally, this study will examine the main form(s)of Fc Receptor expressed in these
patients. The Fc receptor is the hypothesized binding partner of FGL2, and the form
expressed in a given patient may determine the downstream effects of FGL2's binding. These
data along with clinical, biochemical and virological data will be used to determine whether
there is a correlation between FGL2 levels and disease outcome and/or treatment response.
The study will also recruit a group of normal healthy volunteers to give blood samples on
two occasions so that the baseline range of FGL2 levels in healthy individuals can be
established for comparison.
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01708889 -
Pharmacokinetic Study of BMS-914143 in Participants With Normal Renal Function and Mild, Moderate, Severe and End-stage Renal Dysfunction
|
Phase 1 | |
| Active, not recruiting |
NCT00563173 -
Phase I/IIa Dose Ranging CHRONVAC-C® Study in Chronic HCV Patients
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT01813266 -
Prospective Cohort Study: To Provide Evidence & Guidance in Hepatitis C Virus Screening, Comparing the New Birth Cohort Recommendations From the CDC, Versus Classical Traditional Strategies With Established Risk Factors
|
||
| Completed |
NCT01121731 -
A Phase I/II Clinical Trial With Interferon Alfa 5 in Treatment-Experienced Patients With Genotype-1 Chronic Hepatitis C
|
Phase 1/Phase 2 | |
| Completed |
NCT00851890 -
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-333 Alone and in Combination With Pegylated Interferon (pegIFN) and Ribavirin (RBV) in Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
|
Phase 2 | |
| Completed |
NCT04387539 -
ٍٍSofosbuvir/Simeprevir/Daclatasvir/Ribavirin and HCV Genotype 4-infected Egyptian Experienced Participants
|
Phase 1/Phase 2 | |
| Completed |
NCT04391985 -
Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir and Ribavirin for Hepatitis C Virus Genotype 4 Patients
|
Phase 1/Phase 2 | |
| Completed |
NCT00770198 -
sgp130 in Chronic Human Liver Disease
|
N/A | |
| Completed |
NCT04382937 -
Ropeginterferon Alfa-2b (P1101) Phase 3 Study in Interferon Treatment-Naive Subjects With HCV Genotype 2 Infection
|
Phase 3 | |
| Recruiting |
NCT00294489 -
Methacetin Breath Test in HCV Patients With Normal and Near-Normal ALT
|
Phase 3 | |
| Withdrawn |
NCT00255359 -
Safety, Tolerability and Efficacy of XTL 2125 in HCV-Infected Patients Who Are Interferon-Alpha Non-Responders or Relapsers
|
Phase 1 | |
| Completed |
NCT00570336 -
Study of CTS-1027 in Hepatitis C Patients
|
Phase 2 | |
| Completed |
NCT02292719 -
A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection
|
Phase 2 | |
| Terminated |
NCT01080222 -
A Safety and Efficacy Study of the Combination of VX-222 and Telaprevir in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection
|
Phase 2 | |
| Completed |
NCT04385407 -
Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients
|
Phase 2 | |
| Completed |
NCT04387526 -
Sofosbuvir Plus Daclatasvir With or Without Ribavirin and Chronic HCV Genotype (GT) 4
|
Phase 2/Phase 3 | |
| Completed |
NCT00215865 -
PEG-Interferon a-2b + Ribavirin for Treatment of Patients With Chronic Hepatitis C Who Have Previously Failed to Achieve a Sustained Virologic Response Following Interferon Alfa or Interferon a-2b + Ribavirin Therapy
|
Phase 3 |