A Comparative, Randomized, Open-label, Multicenter Study, of Directly Observed Treatment of Chronic Hepatitis C (DOT) and auto administrated treatment with Copegus® (Ro 20-9963) and Pegasys® (Ro 25-8310). - ribadot

Active, not recruiting

• Conditions: Chronic Hepatitis C; Classification code 10008912

• Registration Number: EUCTR2005-005650-41-ES
• Lead Sponsor: SESP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 <100 ng/mL within 2 months prior to randomization.
7.Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of stud drug. Also, all fertile males and females must be using two forms of effective contraception contraceptive during treatment and during the six months after treatment end. Roche will give patients the two forms os contraception (condom with spermicide)
8.Patients with positive test of anticuerpos IgM anti-VHB chronic and/or anticuerpos anti-VIH.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified