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
- Conditions
- Treatment of chronic infections caused by hepatitis C virus genotype 1 strainsMedDRA version: 8.1Level: LLTClassification code 10008912Term: Chronic hepatitis C
- Registration Number
- EUCTR2007-002901-33-SE
- Lead Sponsor
- Tripep AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method