EUCTR2008-000706-36-DE进行中（未招募）1 期
Optimization of treatment for patients with chronic hepatitis C infected with HCV-genotype 2 or 3: 12 vs. 24 weeks of treatment extension for patients without rapid virological response - OPTEX 2/3
Hannover Medical School; Competence Network Viral Hepatitis (Hep-Net)0 个研究点目标入组 150 人开始时间: 2008年5月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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
- •1. Male or female patients with HCV-genotype 2/3 chronic hepatitis C documented by detectable plasma HCV RNA (> 15 IU/mL) and positivity of anti-HCV antibodies
- •2. Age = 18 years
- •3. Compensated liver disease (Child-Pugh Grade A clinical classification)
- •4. Negative urine or blood pregnancy test (one of the both; for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 7 months after treatment end. This includes using birth control pills (no interaction with investigational drugs), IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state. At least one contraception method must be of barrier method
- •5. Ongoing treatment with 1.5 µg/kg Peg-Interferon alpha-2b (PegIntron®) and > 10.6 mg/kg ribavirin (Rebetol®)
- •6. No rapid virological response (HCV-RNA positive after week 4 of the ongoing therapy)
- •7. Willingness to give written informed consent and willingness to participate to and to comply with the study protocol
- •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 143
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •1. Women with ongoing pregnancy or breast feeding
- •2. Male partners of women who are pregnant
- •3. Coinfection with HIV or HBV
- •4. History or other evidence of a medical condition associated with chronic liver disease other than HCV associated (e.g. hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)
- •5. History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
- •6. Patients with liver cirrhosis with a lesion suspicious for hepatic malignancy on the screening
- •7. Absolute neutrophil count (ANC) <750 cells/mm3 at screening
- •8. Platelet count <50,000 cells/mm3 at screening
- •9. Hb <10 g/dl at screening
- •10. Dose modification of Peg-Interferon alpha-2b (PegIntron®) or ribavirin (Rebetol®) during the first 4 weeks of the ongoing therapy
- •11. Interferon alpha or ribavirin therapy at any time point before the actual ongoing treatment
- •12. Less than 80% adherence to treatment of the ongoing treatment until randomization (week 20-22 of ongoing treatment)
- •13. Serum creatinine level >1.5 times the upper limit of normal at screening
- •14. History of severe psychiatric disease, especially depression (ICD 10 codes F30–F33). Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time. Patients are excluded if any history of suicidal attempts is evident. If hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease are documented, psychiatric consultation is mandatory. Patients with a mild or moderate psychiatric disease (ICD 10 codes F32.0, F32.1, F33.0, F33.1) are only allowed to be included into the trial if a regular monitoring by a psychiatrist is performed during the trial
- •15. History of a severe seizure disorder or current anticonvulsant use
- •16. History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis)
- •17. History or any other evidence of autoimmune diseases
- •18. History or other evidence of chronic pulmonary disease associated with functional limitation
- •19. History of significant cardiac disease that could be worsened by acute anemia (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months prior to treatment with Peg-Interferon/ribavirin therapy, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina)
- •20. Evidence of thyroid disease that is poorly controlled on prescribed medications
- •21. Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration)
- •22. History of major organ transplantation with an existing functional graft
- •23. History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- •24. History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
- •25. Patients with evidence for tuberculosis
- •26. Drug abuse within 6 months prior to the first dose of study drug and excessive alcohol consumption. Patients on methadone/polamidone/buprenorphine programs are
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