A Safety and Efficacy Study of CHRONVAC-C followed by Standard Treatment of Hepatitis C infected Patients.

Active, not recruiting

• Conditions: Treatment of chronic infections caused by hepatitis C virus genotype 1 strains; MedDRA version: 13.1Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2010-022960-10-SE
• Lead Sponsor: ChronTech Pharma AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-11
• Last Update Posted: 31 July 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1.Male or female subject 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) and a planned start of standard of care within 12 weeks from screening.

2.Known genotype 1 infection.

3.Viral load equal to 1000 IU/ml or more

4.BMI less than 35.

5.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.

6.Written informed consent obtained, and a copy provided to the subject.

7.Subject legally competent and able to communicate effectively with the study personnel.

8.Subject 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Subject having clinically significant concomitant diseases other than HCV in the medical history to the discretion of the investigator.

2.Subject having clinically significant findings on physical examination, vital signs, ECG or clinical laboratory evaluations to the discretion of the investigator.

3.Subject having clinical or biochemical signs of cirrhosis.

4.Positive hepatitis B surface antigen (HBsAg).

5.Positive HIV antigen or antibody test.

6.Subject having an ongoing and/or known viral infection other than HCV that requires treatment and/or special medical intention.

7.Subject 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. (Corticosteroid nasal sprays, inhaled steroids for asthma and/or topical steroids are allowed, however not on the vaccination area.)

10.Immunization within 30 days of the first dose of the study drug.

11.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.

12.Prior treatment with DNA therapy.

13.Known allergy towards vaccines.

14.Known allergy or contraindications to interferon and/or ribavirin or their excipients

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 subject who is pregnant or breast feeding.

21.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.

22.Female subject with a positive urine pregnancy test.

23.Male subject unwilling to use condom for active prevention of pregnancy from first vaccination to 4 months after last injection.

24.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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified