NCT01121731已完成1 期
Phase I/II, Multicenter, Randomized, Open,Active-Controlled, ClinicalTrial to Evaluate PK, PD, Safety and Tolerability Of Interferon Alfa 5, S.C. 3 Times Per Week, For 29 Days, To Treat-Experienced Pat. With Genotype-1 Chronic Hepatitis C
Digna Biotech S.L.15 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2010年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 15
- 主要终点
- Safe dose level
研究概览
简要总结
The general aim of this study is to determine if 3 MIU of IFN-α5 in monotherapy, and 1,5 MIU of IFN-α5 combined with 1,5 MIU of IFN- α2b, are safe dose levels as well as to investigate the antiviral efficacy and pharmacodynamics (PD) of such doses and drugs in treatment-experienced HCV patients with genotype 1 chronic infection, after 29 days of treatment. It is also intended to determine pharmacokinetics (PK) of the safe dose achieved of IFN-α5 in monotherapy.
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
- •Patients aged ≥18 years old,
- •With chronic hepatitis C (CHC) infection diagnosed by seropositivity for anti-HCV antibodies or detectable HCV-RNA, at least 6 months prior to screening.
- •Patients with CHC infection of genotype 1 (1a, 1b or mixed 1a/1b)
- •Defined as relapsers: those CHC patients who had achieved virologic response (HCV-RNA non detectable) at any time during the standard care of treatment for CHC with IFN-α2 or PegIFN-α2 + ribavirin, and maintained it trough the end of treatment at week 48 weeks, but HCV-RNA detection occurs before 6 months post-treatment.
- •In whom liver cirrhosis has been ruled out through fibro-scan or liver biopsy within 24 months prior to study enrolment.
- •With a serum HCV viral load ≥ 100.000 IU/mL at screening
- •With alanine-aminotransferase (ALT) and aspartate-aminotransferase (AST) serum measurements at screening less than 5 times of their upper limits of normal (ULN)
- •With a body mass index (BMI) of at least 18 kg/m2, but not exceeding 36 kg/m
- •For female subjects with childbearing potential: use of a known highly effective method of birth control
- •For male subjects with partners of child bearing potential: use of appropriate contraceptive methods.
- •Is able to effectively communicate with the investigator and other testing center personnel.
- •Is able to participate and willing to give written informed consent and comply with the study restrictions.
- •Exclusion Criteria(principal):
- •Hepatitis C infection of genotype 2, 3 or 4 or any mixed genotype (1/2, 1/3 and 1/4).
- •A positive ELISA for HIV-1 or HIV-
- •Hepatitis B virus (HBV) infection based on the presence of HBsAg.
- •Hepatitis A virus (HAV) infection based on the presence of antiHAV-IgM. (AM 4)Criteria deleted
- •Decompensated liver disease, or history of decompensated liver disease.
- •History or other evidence of a medical condition associated with decompensated renal, immunologically mediated, chronic pulmonary, cardiac, thyroid, severe retinopathy, severe psychiatric, organ transplantation, cancer, seizure disorder or pancreatitis diseases.
- •An active or suspected malignancy or history of malignancy within the last five years.
- •Patients with a documented drug and alcohol addiction free history of at least 12 months who are, in the opinion of the investigator unlikely to relapse, may be enrolled in the study.
- •Positive results for drug abuse at screening.Occasional use of cannabis previously to randomization is not an exclusion criteria -under investigator team criteria-. The patient should be advised of abstinence during the trial (AM 6)
- •Haemoglobin <12.0g/dL for women, and <13.0g/dL for men at screening.
- •White blood cell count <2000 cells/mm3 at screening.
- •Absolute neutrophil count <1500 cells/mm3 at screening.
- •Platelet count <100.000 cells/mm3 at screening.
- •ALT and AST levels ≥ 5 xULN at screening.
- •Prothrombin time INR prolonged to 1.5xULN at screening.
- •TSH an T4 outside normal limits and not adequately controlled thyroid function at screening.
- •Poorly controlled diabetes mellitus as evidenced by HbA1c >7.5% at screening.
- •Alfa-fetoprotein value >100ng/mL at screening.
- •Total bilirubin >1.5xULN with ratio of direct/indirect >1, at screening unless predominantly conjugated and reflecting Gilbert's disease
- •Estimated creatinine clearance of 30 mL/minute or less at screening.
- •Women who are confirmed to be pregnant
- •People with known hypersensitivity to any ingredient of the investigational agents
- •Patients who are at risk of bleeding.
- •Haemoglobinopathy
- •Screening ECG QTc value ≥ 450ms and/or clinically significant ECG findings.
- •History of clinically significant drug allergies.
- •Participation in a clinical study with an investigational drug, biologic, or device within 3 months prior to anticipated dose administration.
- •Any chronic viral (including HSV), bacterial, mycobacterial, fungal, parasitic, or protozoal infection.
- •Requirement for chronic systemic corticosteroids.
- •Receiving systemic antivirals, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to enrollment.
排除标准
- 未提供
研究组 & 干预措施
Interferon α-5
Experimental
干预措施: Interferon α-5 (Drug)
Interferon α-5 plus Interferon α-2b
Experimental
干预措施: Interferon-α5 plus Interferon-α 2b (Drug)
Interferon α-2b (INTRON® A)
Active Comparator
干预措施: Interferon α-2b (INTRON® A) (Drug)
结局指标
主要结局
Safe dose level
时间窗: 29 days of treatment
PRIMARY ENDPOINTS OF PHASE I * To determine if 3 MIU of IFN-α5 are well tolerated and if not, to find a safe dose level for IFN-α5. * To determine if 1.5 MIU of IFN-α5 in combination with 1.5 MIU of IFN-α2b (IFN-α5 + IFN-α2b) are well tolerated and if not, to find a safe dose level for the combination of IFN-α5 and IFN-α2b. PRIMARY ENDPOINTS OF PHASE II * To analyze IFN-α5 preliminary antiviral efficacy at the dose of 3 MIU, or the safe dose level identified in Phase I. * Primary safety endpoints: Occurrence of AE (classified into mild, moderate and severe)
次要结局
- pharmacodynamic and pharmacokinetic parameters(29 days of treatment)
研究者
研究点 (15)
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