| Trial ID: | L3781 |
| Source ID: | NCT00188240
|
| Associated Drug: |
Pegasys; Copegus.
|
| Title: |
Insulin Resistance Associated With Chronic Hepatitis C (CHC) and the Effect of Antiviral Therapy
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hepatitis C|Hepatitis B
|
| Interventions: |
DRUG: Pegasys; Copegus.
|
| Outcome Measures: |
Primary: 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.|Phase II - Interventional phase - To evaluate the effect of anti-viral therapy on insulin resistance, determined by the OGTT method, in patients with hepatitis C found to have insulin resistance pre-treatment.|- 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). |
|
| Sponsor/Collaborators: |
Sponsor: University Health Network, Toronto
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
200
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2003-08
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2005-11-29
|
| Locations: |
Liver Clinic, Toronto Western Hospital, UHN., Toronto, Ontario, M5T 2S8, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT00188240
|
