Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00606528
Other study ID # 07-0841-T
Secondary ID
Status Completed
Phase N/A
First received January 21, 2008
Last updated July 24, 2013
Start date February 2008

Study information

Verified date July 2013
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date
Est. primary completion date July 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility HCV patient population

Inclusion Criteria:

- able to give written consent

- 18-70 yrs of age, both genders

- willing to use adequate contraception

- diagnosis of chronic HCV infection (of any genotype) based on 2 positive serology tests

- availability of pre- and post-treatment viral load data

- naive to antiviral treatment

- availability of pre-treatment liver biopsy

Exclusion Criteria:

- less than 18 yrs, greater than 70 yrs of age

- pregnancy

- HBV, HDV, or HIV co-infection

- any history of active alcohol or drug abuse

Volunteer Population (Control)

Inclusion Criteria:

- able and willing to provide written informed consent

- willing to provide a brief review of medical history

- 18-70 yrs of age, of either gender

Exclusion Criteria:

- less than 18, greater than 70 yrs of age

- any history of liver, renal, lung, hematological or coronary artery disease

- any history of active alcohol or drug abuse

- any previous diagnosis of HBV, HCV, HDV or HIV

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Other:
No intervention
None. This is an observational study.

Locations

Country Name City State
Canada University Health Network Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Chan CW, Kay LS, Khadaroo RG, Chan MW, Lakatoo S, Young KJ, Zhang L, Gorczynski RM, Cattral M, Rotstein O, Levy GA. Soluble fibrinogen-like protein 2/fibroleukin exhibits immunosuppressive properties: suppressing T cell proliferation and inhibiting maturation of bone marrow-derived dendritic cells. J Immunol. 2003 Apr 15;170(8):4036-44. — View Citation

Liu H, Zhang L, Cybulsky M, Gorczynski R, Crookshank J, Manuel J, Grant D, Levy G. Identification of the receptor for FGL2 and implications for susceptibility to mouse hepatitis virus (MHV-3)-induced fulminant hepatitis. Adv Exp Med Biol. 2006;581:421-5. — View Citation

Shalev I, Liu H, Koscik C, Bartczak A, Javadi M, Wong KM, Maknojia A, He W, Liu MF, Diao J, Winter E, Manuel J, McCarthy D, Cattral M, Gommerman J, Clark DA, Phillips MJ, Gorczynski RR, Zhang L, Downey G, Grant D, Cybulsky MI, Levy G. Targeted deletion of fgl2 leads to impaired regulatory T cell activity and development of autoimmune glomerulonephritis. J Immunol. 2008 Jan 1;180(1):249-60. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary correlation between blood FGL2 levels and response to antiviral therapy 6 months after the end of treatment No
Secondary correlation between FGL2 levels and Treg percentage in blood and liver cells all time points No
See also
  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 NCT04391985 - Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir and Ribavirin for Hepatitis C Virus Genotype 4 Patients Phase 1/Phase 2
Completed NCT04387539 - ٍٍSofosbuvir/Simeprevir/Daclatasvir/Ribavirin and HCV Genotype 4-infected Egyptian Experienced Participants 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