Chronic hepatitis C Hepatitis C crónica MedDRA version: 9.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C
Conditions
Interventions
Trade Name: Pegasys, 180 microgramos, solución inyectable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PEGINTERFERON ALFA 2A
CAS Number: 198153-51-4
Current Sponsor code: Ro 25-831
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - As described in protocol section 2 (Objectives of the study) - Be eligible for treatment or re-treatment as defined in the donor protocol - Have completed safety and efficacy assessments as defined in the donor protocol without violation or major deviation - Have not received any other anti-HCV treatment after the completion of the donor protocol - Have a negative pregnancy test (for females of childbearing potential) documented within the 24-hour period prior to the first dose of study drugs. Additionnally, fertile patients (males and females) must use two reliable forms of effective contraception (combined) during the entire period of the study (treatment and follow-up) in accordance with locally approved label for ribavirin (COPEGUS). 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Females who are pregnant or breast-feeding - Male partners of females who are pregnant - Patients with hemoglobinopathies - Hepatic decompensation (Child-Pugh class B and C) before or during treatment - Neutrophil counts < 1500 cells/mm3, platelet counts < 90000 cells/mm3 or Hgb < 12 g/dL in females or < 13 g/dL in males - Non-responder patients (defined as patients previously treated with PEGASYS and COPEGUS combination therapy at standard doses for at least 12 weeks and did not achieve at least a 2 log drop from their baseline viral load - History of: - Severe neuropsychiatric disease, especially depression - Significant or unstable cardiac disease - Inadequately controlled hypothyroidism or hyperthyroidism - Inadequately controlled hyperglycemia, hypoglycemia or diabetes mellitus - Immunologically mediated disease including myositis, inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, interstitial nephritis, rheumatoid arthritis requiring more than intermittent nonsteroidal anti-inflammatory medications for management - Chronic pulmonary disease associated with functional limitation - Severe retinopathy - Major organ transplantation with an existing functional graft - History or other evidence of a medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, Wilson?s disease, alpha1 antitrypsin deficiency, alcoholic liver disease, and toxin exposures) - Evidence of an active or suspected cancer or a history of malignancy where the risk of recurrence is greater than or equal to 20% within 2 years. Patients with a lesion suspicious for hepatic malignancy on the screening imaging study will only be eligible if the likelihood of carcinoma is less than or equal to 10% following an appropriate evaluation. - History of any systemic anti-neoplastic or immunomodulatory treatments (including steroids given at non-physiologic doses and radiation) - History or other evidence of severe illness or any other conditions (e.g. pancreatitis) which would make the patient, in the opinion of the investigator, unsuitable for the study - Evidence of alcohol and/or drug abuse - Inability or unwillingness to provide informed consent or abide by the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide treatment or re-treatment to patients with chronic hepatitis C (CHC) who have participated in a previous Roche or Roche partner protocol where access to treatment or re-treatment with PEGASYS as monotherapy or in combination with COPEGUS was promised or deemed appropriate following completion of the original protocol (?donor? protocol).;Secondary Objective: n.a.;Primary end point(s): n.a. | — |
Countries
Austria, France, Germany, Spain
Outcome results
None listed