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Antiviral
Antiviral Therapy for Chronic Hepatitis C and Insulin Resistance
N/A
Waitlist Available
Led By E.J.L (Jenny) Heathcote, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will help to understand if there is a relationship between hepatitis C and insulin resistance that is independent of other causes of liver disease. If our hypothesis is correct, this will have implications for the treatment and management of patients with chronic hepatitis C.
Who is the study for?
This trial is for individuals with chronic hepatitis C without cirrhosis, who have insulin resistance but not type 2 diabetes. They must be attending the Liver Clinic in Toronto, show evidence of hepatitis C infection, and agree to use two forms of contraception if fertile. Excluded are those with conditions like anemia risks, decompensated liver disease, severe kidney issues, pregnancy or breastfeeding women, heavy alcohol users, and those on certain medications.Check my eligibility
What is being tested?
The study investigates whether people with chronic hepatitis C have more insulin resistance than those with chronic hepatitis B and if antiviral therapy can improve insulin resistance in hepatitis C patients. It's a two-phase study: first assessing prevalence of insulin resistance in hep C versus hep B patients; then treating hep C patients (with no other risk factors) who are insulin resistant to see if their condition improves.See study design
What are the potential side effects?
Potential side effects aren't detailed here but may include reactions related to antiviral therapy such as fatigue, headache, nausea or mood changes. Specific side effects will depend on the particular antiviral drugs used for treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
- To evaluate the safety, efficacy and tolerability of Pegasys (peginterferon alfa-2a) given in combination with Copegus (ribavirin) given for 24 weeks or 48 weeks in treatment naïve patients with chronic hepatitis C (CHC).
Phase I - To evaluate the prevalence of insulin resistance in patients with hepatitis C without cirrhosis and compare it to that observed in patients with hepatitis B also without cirrhosis.
Hepatitis C
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Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,465 Previous Clinical Trials
483,489 Total Patients Enrolled
15 Trials studying Hepatitis C
974 Patients Enrolled for Hepatitis C
E.J.L (Jenny) Heathcote, MDPrincipal InvestigatorUHN - Toronto Western Hospital, University of Toronto
4 Previous Clinical Trials
880 Total Patients Enrolled
2 Trials studying Hepatitis C
350 Patients Enrolled for Hepatitis C
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently pregnant or breastfeeding.I do not have active hepatitis A, B, or HIV.I show signs or have symptoms of liver cancer.I have a history of severe mental health issues, including depression.I have a severe seizure disorder or am currently using anticonvulsant medication.I am not taking any medications that can cause diabetes, including steroids.I haven't had cancer treatment or high-dose steroids in the last 6 months.I have heart or brain blood vessel issues and a drop in hemoglobin would be risky for me.I have had bleeding due to severe liver disease.I have a liver condition not caused by hepatitis C.My thyroid disease is not well-managed with medication.I have severe eye disease, like CMV retinitis or macular degeneration.I have been diagnosed with cirrhosis through a liver biopsy.I have been treated for hepatitis C or received alfa-interferon.My partner is currently pregnant.My hemoglobin level is below the normal range for my gender.I have a condition or history that increases my risk of anemia.I am either male or female.I have Type II diabetes.I am using two effective birth control methods during and 6 months after Copegus treatment.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment open to new participants?
"According to clinicaltrials.gov, the ongoing recruitment for this particular research trial has concluded; however, 467 other medical trials are presently recruiting patients. This study was initially announced on August 1st 2003 and last updated November 28th 2005."
Answered by AI
Are there any eligibility criteria for involvement in this research project?
"This clinical trial seeks 200 participants aged between 18 and 85 with hepatitis b. To be considered eligible, patients must additionally meet the following requirements: attending Liver Clinic at Toronto Western Hospital in Canada, all fertile males or females using two forms of contraception during treatment and its 6-month follow-up period, insulin resistance exceeding 2.1 verified by HOMA analysis, both genders accepted for enrollment."
Answered by AI
Does this research involve elderly participants?
"This trial is open to individuals who are of legal age and not older than 85 years."
Answered by AI
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