20 Years
65 Years
Both
Hepatocellular Carcinoma in Hepatitis C Virus Infected Patients
Trial Information
Our prospective research is carried out in one of the stem cell therapy centers in Egypt
where 140 hepatitis C virus infected patients attending for stem cell therapy are enrolled
in our study and the patients will be followed up after stem cell therapy where the
incidence of hepatocellular carcinoma after stem cell therapy will be calculated , another
group of hepatitis C virus infected patients attending to Kasr El Aini university hospital
to receive the standered line of care as indicated will be enrolled in our study and will be
followed up , where the incidence of hepatocellular carcinoma will be calculated and
compared to the previous group , to determine if there is a significant difference between
both groups regarding the incidence of hepatocellular and determine whether stem cell
therapy affecets the incidence of hepatocellular carcinoma in hepatitis C virus infected
patients.
Inclusion Criteria:
- Male or female patients aged from 20 to 65 years of age.
- Evidence of chronic liver insufficiency.
- The presence of decreased serum albumin and/or increased bilirubin
and/or increased international normalized ratio (INR).
- Patient is unlikely to receive a liver transplant.
- Ability to give written consent
- Women of childbearing potential may be included, but must use a reliable and
appropriate contraceptive method
Exclusion Criteria:
- Patients below the age of 20 or above the age of 65 years
- Pregnant or lactating women
- Patients with recent recurrent GI bleeding or spontaneous bacterial peritonitis
- Patients with evidence of HIV or other life threatening infection
- Patients unable to give informed consent
- Patients with a history of hypersensitivity to G-CSF
- Patients who have been included in any other clinical trial within the previous month
- Patient with recurrent attacks of hepatic encephalopathy.
- Evedince of portal vein thrombosis by ultrasound.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Incidence of hepatocellular carcinoma post stem cell therapy in hepatitis C virus infected patients
Outcome Time Frame:
within the first year after stem cell therapy
Safety Issue:
No
Principal Investigator
Zekri Abdelrahman, M.SC, Ph,D
Investigator Role:
Study Chair
Investigator Affiliation:
National Cancer Institute , Cairo University
Authority:
Egypt: Ministry of Higher Education
Study ID:
1
NCT ID:
NCT01729221
Start Date:
January 2010
Completion Date:
December 2013
Related Keywords:
- Hepatocellular Carcinoma in Hepatitis C Virus Infected Patients
- Hepatocellular carcinoma
- Hepatitis C virus
- Carcinoma
- Hepatitis
- Hepatitis A
- Hepatitis C
- End Stage Liver Disease
- Carcinoma, Hepatocellular
Name | Location |
|---|
