EUCTR2008-002022-10-ES进行中（未招募）不适用
Protocolo multicéntrico abierto en el que se proporciona interferón pegilado alfa-2a (PEGASYS®) en monoterapia o en combinación con ribavirina (COPEGUS®) a pacientes con hepatitis C crónica que han participado en protocolos de Roche anteriores.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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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
- •- 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
排除标准
- •- 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.
研究者
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