NCT01335711Unknown2 期
A Phase II Open-Label, Randomized, Parallel Group, Safety, Tolerability and Efficacy Study of i.m. Administered CHRONVAC-C in Combination With Electroporation Followed by Standard of Care in Chronic Hepatitis C Virus Genotype 1 Infected and Treatment Naïve Subjects
ChronTech Pharma AB2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Rapid Viral Response (RVR). Percent subjects reaching non-detectable level of HCV-RNA.
研究概览
简要总结
To explore the effect on early viral kinetics and viral load, and to determine safety, tolerability and anti-viral response for the plasmid DNA vaccine CHRONVAC-C administered i.m. in combination with electroporation followed by standard of care (SOC) in treatment naïve chronic HCV genotype 1 patients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject 18 - 65 years of age with a known chronic hepatitis C infection, being treatment naїve (that is not being earlier treated for HCV infection) and a planned start of standard of care within 12 weeks from screening.
- •Known genotype 1 infection.
- •Viral load equal to 1000 IU/ml or more
- •BMI less than
- •Considered probable that the deltoid muscles (left and right) of the subject will be reached at vaccination using a 12.7 mm cannula for injection and a 15 mm applicator tip for electroporation.
- •Written informed consent obtained, and a copy provided to the subject.
- •Subject legally competent and able to communicate effectively with the study personnel.
- •Subject likely to co-operate and attend the clinic at the appointed times during the study
排除标准
- •Subject having clinically significant concomitant diseases other than HCV in the medical history to the discretion of the investigator.
- •Subject having clinically significant findings on physical examination, vital signs, ECG or clinical laboratory evaluations to the discretion of the investigator.
- •Subject having clinical or biochemical signs of cirrhosis.
- •Positive hepatitis B surface antigen (HBsAg).
- •Positive HIV antigen or antibody test.
- •Subject having an ongoing and/or known viral infection other than HCV that requires treatment and/or special medical intention.
- •Subject having received previous treatment for HCV.
- •Radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to the first dose of study drug.
- •Treatment with immunomodulating agents such as systemic corticosteroids, IL-2, IFN-alpha, IFN-beta, IFN-gamma within 4 weeks prior to the first dose of study drug. (Corticosteroid nasal sprays, inhaled steroids for asthma and/or topical steroids are allowed, however not on the vaccination area.)
- •Immunization within 30 days of the first dose of the study drug.
- •Subject having received an investigational drug product, or been enrolled in other investigational drug protocols within a period of 30 days prior to receiving the first dose of the study drug.
- •Prior treatment with DNA therapy.
- •Known allergy towards vaccines.
- •Known allergy or contraindications to interferon and/or ribavirin or their excipients
- •Known abuse of alcohol, drugs or pharmaceuticals.
- •History, signs or symptoms of a cardiac disease.
- •Presence of an implantable pacemaker.
- •Any metal implants within the treatment areas (close to the right and/or left deltoid muscles).
- •Diagnoses of a serious psychiatric illness which may influence study participation.
- •Female subject who is pregnant or breast feeding.
- •Female subject not clinically sterile (hysterectomy, tubal ligation or postmenopausal (amenorrhea > 1 year and FSH > 30 mU/ml) OR if not clinically sterile unwilling to use a reliable contraception method.
- •Female subject with a positive urine pregnancy test.
- •Male subject unwilling to use condom for active prevention of pregnancy from first vaccination to 4 months after last injection.
- •Subject or their immediate families being an investigator or site personnel directly affiliated with this study. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted.
研究组 & 干预措施
IMP_C/C IL28B
Experimental
C/C IL28B subjects to whom IMP will be administrated prior to SOC
干预措施: ChronVac-C + SOC (Drug)
SOC_C/C IL28B
Active Comparator
C/C IL28B subjects to whom only SOC will be administrated
干预措施: SOC (Drug)
IMP_non-C/C IL28B
Experimental
non-C/C IL28B subjects to whom IMP will be administrated prior to SOC
干预措施: ChronVac-C + SOC (Drug)
SOC_non-C/C IL28B
Active Comparator
non-C/C IL28B subjects to whom only SOC will be administrated
干预措施: SOC (Drug)
结局指标
主要结局
Rapid Viral Response (RVR). Percent subjects reaching non-detectable level of HCV-RNA.
时间窗: 4 weeks after SOC onset
Early viral kinetics - Second phase slope of viral decline
时间窗: 0-4 weeks after SOC onset
Partial Early Viral Response (pEVR). Percent HCV-RNA positive subjects with more than 2 log 10 decline in HCV-RNA.
时间窗: 12 weeks after SOC onset
Complete Early Viral Response (cEVR). Percent subjects reaching non-detectable level of HCV-RNA.
时间窗: 12 weeks after SOC onset
次要结局
- Change from baseline in vital signs(0 - 12 weeks)
- Number of patients with AEs(12 weeks)
- Change of blood status from baseline(0 - 12 weeks)
- Exploratory Analysis - Characterization and quantification of the vaccine primed NS3-immune response(0 - 12 weeks)
- Local tolerance(up to 12 weeks after SOC onset)
研究者
研究点 (2)
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