Chronic Hepatitis C Infection Clinical Trial
Official title:
The Role of FGL2-FcgammaRIIB Inhibitory Pathway in Human Viral Hepatitis
Verified date | November 2016 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Observational |
Viral hepatitis is a serious world health problem affecting over 1 billion people worldwide. Presently the lack of highly effective treatments results in many patients requiring liver transplantation or death. The investigators have defined the role of a unique molecule FGL2 and its receptor fc-gammaR and its role in the pathogenesis of both experimental and human hepatitis. The studies proposed in the present proposal will test the hypothesis that measuring levels of fgl2 in plasma will identify individuals that will go on to develop chronic disease and inhibition of binding of fgl2 to its receptor will allow the host with both acute and chronic disease to develop an appropriate immune response and clear the virus. The studies will provide rationale for generation of new therapies to improve the treatment of patients with acute and chronic viral hepatitis by targeting fgl2.
Status | Completed |
Enrollment | 106 |
Est. completion date | September 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Able and willing to give written informed consent 2. Willing to follow the study protocol 3. Between >18 and <70 years of age, both gender 4. No history of active alcohol or drug abuse 5. Adequate contraception for both gender 6. Diagnosis of chronic HCV infection based on two positive serology tests. 7. Pre- and post treatment viral load data must be available 8. Naïve to antiviral treatment 9. A pre treatment liver biopsy should be available for all patients Exclusion Criteria: 1. All other genotypes than genotype 1 2. Less than 18 or greater than 70 years of age 3. Pregnancy 4. Co-infection with HBV (hepatitis B virus), HDV (Hepatitis Delta virus) or HIV co-infection 5. Coexistence of liver disease of other etiology (autoimmune, alcohol) 6. Evidence of hepatocellular carcinoma |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Foerster K, Helmy A, Zhu Y, Khattar R, Adeyi OA, Wong KM, Shalev I, Clark DA, Wong PY, Heathcote EJ, Phillips MJ, Grant DR, Renner EL, Levy GA, Selzner N. The novel immunoregulatory molecule FGL2: a potential biomarker for severity of chronic hepatitis C — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To correlate plasma levels of FGL2 in patients who undergo antiviral therapy for chronic HCV infection with clinical outcome | 6 months after end of antiviral treatment | No | |
Secondary | to correlate levels of FGL2 to numbers and immune function of CD4+ and CD8+ T cells, and DC activity | at all timepoints; pre-treatment, at wks 4, 12 and 48 of treatment and 6 months after end of treatment | No |
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