Chronic Hepatitis C Classification code 10008912
Conditions
Interventions
Trade Name: Pegasys
Product Name: Pegasys
Product Code: Ro 25-8310
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Peginterferon alfa-2a
Concentration unit: µg/ml microgram(s)/millili
Sponsors
SESP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female ?18 years of age 2. Serologic evidence of chronic hepatitis C infection by an anti-HVC antibody test 3. Serum HCV-RNA quantifiable at >600 IU/mL 4. Hepatic biopsy, if necessary, according to daily clinical practice, valuated by a local pathologist who confirms the diagnostic of CHC. (Exception: hemophiliac patients for whom biopsy is clinically contraindicated will not require it). 5. Compensated liver disease (Child-Pugh Grade A clinical classification in cirrhotic patients). 6. Patients with cirrhosis or transition to cirrhosis must have an abdominal ultrasound, CT scan, or MRI scan without evidence of hepatocellular carcinoma and a serum AFP =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Women with ongoing pregnancy or breast feeding 2. Male partners of women who are pregnant 3. Signs or symptoms of hepatocellular carcinoma 4. Therapy with any systemic anti-viral, anti-neoplastic or inmunomodulatory treatment *6 months prior to the first dose of study drug, except previous PEG-IFN alfa-2b and ribavirin. It includes amantadine, histamine, mofectil mycofenolate, alpha thymosin, viramidine, levovirine and suprafisiologyc doses of steroids and radiation. Except: patients who had received a limit treatment (?7 days), at least 1 month prior to the first dose of the medication of the study, with acyclovir or valacyclovir for herpes damages, or antiretroviral treatment for HIV, will not de excluded. 5. Positive test at screening for anti-HAV IgM Ab 6. History of other evidence of a medical condition associated with chronic liver disease other than HCV 7. History or other evidence of decompensate liver disease or a Child-Pugh>6 8. Hgb < 12 g/dL (<120 g/L) in women or <13 g/dL (<130 g/L) in men at screening 9. Any patient with an increased baseline risk for anemia 10. History of severe psychiatric disease 11. History of a severe seizure disorder or current anticonvulsant use as anticonvulsive therapy 12. History of immunological disease 13. History of any severe cardiac disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if the directly observed administration of the treatment of chronic hepatitis C (CHC) involves more efficacy than the same treatment auto administrated. [We will valuate the proportion of patients that have sustained virological response (SVR) (DOT versus Not DOT)];Secondary Objective: • To assess the proportion of patients that have early virological response (EVR) (week 12) and virological response at the end of the treatment (FVR) (DOT versus Not DOT) • To assess, both for Pegasys® and Copegus®, if the proportion of patients with SVR depends on: - Permanence on the treatment - % of received doses • To evaluate the safety of Pegasys® therapy in combination with Copegus® • To assess the efficacy in the different stratums of studied population (coinfection, monoinfection, high/normal ALT, cirrhosis, viral load, viral genotype), comparing the rates of SVR according to DOT or Not DOT ;Primary end point(s): The primary end point is the PCR cuantitative analisys in the th week after the end of treatment. It will be evaluated the patients with sustained virological response in each rgroup of treatment (DOT and No DOT) | — |
Countries
Spain
Outcome results
None listed