E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Classification code | 10008912 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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)] |
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E.2.2 | Secondary objectives of the trial |
• 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
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Autoadministred treatment |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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last patient, last visit (the last follow-up visit will be done 24 weeks after completing the treatment) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 7 |