EUCTR2007-002901-33-SE进行中（未招募）不适用
A Phase I/IIa Open-Label, Dose Ranging, Parallel, Safety, Tolerability and Efficacy Study of i.m. Administered ChronVac-C® in Combination with Electroporation in Chronic Hepatitis C Virus Genotype 1 Infected and Treatment Naïve Patients with Low Viral Load - Phase I/IIa Dose Ranging CHRONVAC-C® Study in Chronic HCV Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Tripep AB
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 patient 18 – 65 years of age with a known chronic hepatitis C infection, being treatment na?ve (that is not being earlier treated for HCV infection).
- •2. Known genotype 1 infection.
- •3. Viral load equal to or less than 800.000 IU/mL.
- •4. BMI less than 30.
- •5. Considered probable that the deltoid muscles (left and right) of the patient will be reached at vaccination using a 12.7 mm cannula for injection and a 15 mm applicator tip for electroporation.
- •6. Written informed consent obtained, and a copy provided to the patient.
- •7. Patient legally competent and able to communicate effectively with the study personnel.
- •8. Patient likely to co-operate and attend the clinic at the appointed times during the study.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient having clinically significant concomitant diseases other than HCV in the medical history to the discretion of the investigator.
- •2. Patient having clinically significant findings on physical examination, vital signs, ECG or clinical laboratory evaluations to the discretion of the investigator.
- •3. Patient having clinical or biochemical signs of cirrhosis.
- •4. Positive hepatitis B surface antigen (HBsAg).
- •5. Positive HIV antigen or antibody test.
- •6. Patient having an ongoing and/or known viral infection other than HCV that requires treatment and/or special medical intention.
- •7. Patient having received previous treatment for HCV.
- •8. Radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to the first dose of study drug.
- •9. 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.
- •10. Treatment with systemic NSAID within 10 days of the first dose of study drug.
- •11. Immunization within 30 days of the first dose of the study drug.
- •12. Patient 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.
- •13. Prior treatment with DNA therapy.
- •14. Known allergy towards vaccines.
- •15. Known abuse of alcohol, drugs or pharmaceuticals.
- •16. History, signs or symptoms of a cardiac disease.
- •17. Presence of an implantable pacemaker.
- •18. Any metal implants within the treatment areas (close to the right and/or left deltoid muscles).
- •19. Diagnoses of a serious psychiatric illness which may influence study participation.
- •20. Female patient who is pregnant or breast feeding.
- •21. Female patient 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.
- •22. Patient with a positive urine pregnancy test.
- •23. Male patient unwilling to use condom for active prevention of pregnancy from first vaccination to 4 months after last injection.
- •24. Patient 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.
研究者
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