| Trial ID: | L4241 |
| Source ID: | NCT00370617
|
| Associated Drug: |
Metformin
|
| Title: |
Pegylated-Interferon and Ribavirin Plus Metformin in the Treatment of Chronic HCV Infection and Insulin Resistance
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Hepatitis C|Insulin Resistance
|
| Interventions: |
DRUG: metformin
|
| Outcome Measures: |
Primary: Combined end-point of non-detectable serum HCV-RNA (<100 copies/mL) and|normal serum ALT activity at the end of the 24 week treatment-free follow up period | Secondary: End-of-treatment virological and biochemical response|Sustained virological and biochemical response|End-of-treatment improvement of insulin resistance|End-of-treatment improvement of liver histology
|
| Sponsor/Collaborators: |
Sponsor: University of Turin, Italy
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
200
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2006-09
|
| Completion Date: |
2009-01
|
| Results First Posted: |
|
| Last Update Posted: |
2006-11-14
|
| Locations: |
Division of Gastroenterology, University of Torino, Ospedale San Giovanni Battista, Torino, 10126, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT00370617
|
