NCT00803309终止4 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
HepNet Study House, German Liverfoundation45 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 99
- 试验地点
- 45
- 主要终点
- Reduction of Relapse rate (HCV-RNA positive in serum by a standard HCV-PCR with a detection limit of at least 15 IU/ml) 24 weeks after the end of treatment and thus improvement of sustained virological response rates (SVR)
研究概览
简要总结
In this study we intend to treat patients with chronic hepatitis C of genotype 2 or 3 having characteristics associated with poor treatment response for additional 12 or 24 weeks beyond the standard treatment of PEG-IFN alpha-2b plus ribavirin.
The objective of this study is to compare the efficacy of a treatment extension of 12 versus 24 weeks in patients with HCV-genotypes 2 and 3 who are treated with 1.5 µg/kg PEG-IFN alpha-2b and 800-1400 mg ribavirin (standard dose) for 24 weeks (standard duration) and who are not HCV-RNA negative (< 15 IU/ml) after 4 weeks of standard treatment but HCV-RNA negative after 16-24 weeks of standard treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and 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
- •Age ≥ 18 years
- •Compensated liver disease (Child-Pugh Grade A clinical classification)
- •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
- •Ongoing treatment with 1.5 µg/kg Peg-Interferon alpha-2b (PegIntron®) and > 10.6 mg/kg ribavirin (Rebetol®)
- •No rapid virological response (HCV-RNA positive after week 4 of the ongoing therapy)
- •Willingness to give written informed consent and willingness to participate to and to comply with the study protocol
排除标准
- •Women with ongoing pregnancy or breast feeding
- •Male partners of women who are pregnant
- •Positive tests at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg, anti-HIV, HIV-RNA
- •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)
- •History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
- •Patients with liver cirrhosis with a lesion suspicious for hepatic malignancy on the screening
- •Absolute neutrophil count (ANC) <750 cells/mm3 at screening
- •Platelet count <50,000 cells/mm3 at screening
- •Hb <10 g/dl at screening
- •Dose modification of Peg-Interferon alpha-2b (PegIntron®) or ribavirin (Rebetol®) during the first 4 weeks of the ongoing therapy
- •Interferon alpha or ribavirin therapy at any time point before the actual ongoing treatment
- •Less than 80% adherence to treatment of the ongoing treatment until randomization (week 20-22 of ongoing treatment)
- •Serum creatinine level >1.5 times the upper limit of normal at screening
- •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
- •History of a severe seizure disorder or current anticonvulsant use
- •History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis)
- •History or any other evidence of autoimmune diseases
- •History or other evidence of chronic pulmonary disease associated with functional limitation
- •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)
- •Evidence of thyroid disease that is poorly controlled on prescribed medications
- •Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration)
- •History of major organ transplantation with an existing functional graft
- •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
- •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
- •Patients with evidence for tuberculosis
- •Drug abuse within 6 months prior to the first dose of study drug and excessive alcohol consumption. Patients on methadone/polamidone/buprenorphine programs are not excluded
- •Any investigational drug and/or participation in another clinical study prior 6 months to the actual ongoing antiviral treatment
- •Limited contractual capability
研究组 & 干预措施
A
Active Comparator
PegIntron® 1.5 µg/kg once weekly (QW) subcutaneous (sc) plus Rebetol® 800-1400 mg per os divided in 2 daily doses for additional 24 weeks beyond standard treatment with 24 weeks follow-up
干预措施: pegylated Interferon alpha-2b (Drug)
A
Active Comparator
PegIntron® 1.5 µg/kg once weekly (QW) subcutaneous (sc) plus Rebetol® 800-1400 mg per os divided in 2 daily doses for additional 24 weeks beyond standard treatment with 24 weeks follow-up
干预措施: Ribavirin (Drug)
B
Active Comparator
PegIntron® 1.5 µg/kg QW sc plus Rebetol® 800-1400 mg per os divided in 2 daily doses for additional 12 weeks beyond standard treatment with 24 weeks follow-up
干预措施: pegylated Interferon alpha-2b (Drug)
B
Active Comparator
PegIntron® 1.5 µg/kg QW sc plus Rebetol® 800-1400 mg per os divided in 2 daily doses for additional 12 weeks beyond standard treatment with 24 weeks follow-up
干预措施: Ribavirin (Drug)
结局指标
主要结局
Reduction of Relapse rate (HCV-RNA positive in serum by a standard HCV-PCR with a detection limit of at least 15 IU/ml) 24 weeks after the end of treatment and thus improvement of sustained virological response rates (SVR)
时间窗: 48 weeks (arm A) or 36 weeks (arm B)
次要结局
- Analysis of quality of life(48 weeks (arm A) or 36 weeks (arm B))
- Biochemical responses as determined by ALT and AST levels at the end of treatment and at the end of follow up.(Arm A: 24 and 24 weeks, arm B: 12 and 24 weeks)
- Severity and frequency of adverse event(48 weeks (arm A) or 36 weeks (arm B))
- Virological response rates (HCV-RNA negative in serum by a standard HCV-PCR with a detection limit of at least 15 IU/ml) at the end of therapy(24 weeks (arm A) or 12 weeks (arm B))
研究者
研究点 (45)
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