An open-label, multicenter protocol providing pegylated interferon alfa-2a (PEGASYS) as monotherapy or in combination with ribavirin (COPEGUS) for patients with chronic hepatitis C who have participated in previous Roche or Roche partner protocols.

• Register: EUCTR
• Last refreshed on: 27 January 2014
• Main ID: EUCTR2008-002022-10-IT
• Date of registration: 12/12/2008
• Prospective Registration: No
• Primary sponsor: F. Hoffmann - La Roche Ltd
• Public title: An open-label, multicenter protocol providing pegylated interferon alfa-2a (PEGASYS) as monotherapy or in combination with ribavirin (COPEGUS) for patients with chronic hepatitis C who have participated in previous Roche or Roche partner protocols.
• Scientific title: An open-label, multicenter protocol providing pegylated interferon alfa-2a (PEGASYS) as monotherapy or in combination with ribavirin (COPEGUS) for patients with chronic hepatitis C who have participated in previous Roche or Roche partner protocols.
• Date of first enrolment: 17/11/2008
• Target sample size: 252
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002022-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 1

Countries of recruitment

Austria, France, Germany, Italy, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
? 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 had at least a 6 month washout period from date of last dose from donor protocol NV19865. To ensure a proper balance between risk and benefit, a longer washout period should be considered for patients who experienced lymphopenia for extended periods of time in donor protocol NV19865; ? 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. Additionally, 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 the locally approved label for ribavirin (COPEGUS).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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:
? 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 < 90,000 cells/mm3 or Hgb < 12 g/dL in females or < 13 g/dL in males, lymphocyte counts < 1500 cells/mm3 ? Non-responder patients (defined as patients previously treated with PEGASYS and COPEGUS combination therapy at standard doses, with ≥ 80% compliance(defined as having taken ≥ 80% of PEGASYS doses, ≥ 80% of COPEGUS doses for ≥ 80% of the time between day of first dose and week 12), 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, optic neuropathy or other serious ocular adverse event ? 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, α1-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 ≥ 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 ≤ 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic Hepatitis C (CHC)
MedDRA version: 14.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Intervention(s)

Trade Name: PEGASYS
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Peginterferon alfa-2a
Concentration unit: µg microgram(s)
Concentration number: 180-

Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ribavirin
Concentration unit: mg milligram(s)
Concentration number: 200-

Trade Name: PEGASYS
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Peginterferon alfa-2a
Concentration unit: µg microgram(s)
Concentration number: 180-

Primary Outcome(s)

Secondary Objective: -

Primary end point(s): -

Main Objective: To provide treatment or re-treatment with PEGASYS as monotherapy or in combination with COPEGUS, to patients with CHC who participated in a previous Roche or Roche partner protocol where access to treatment or re-treatment was promised or deemed appropriate following completion of the original protocol (?donor' protocol).

Secondary ID(s)

2008-002022-10-ES

NV21928