CHRONVAC-C Study Followed by Standard of Care in Chronic Hepatitis C Virus (HCV) Subjects

ChronTech Pharma

Status and phase: Unknown; Phase 2

Conditions: Chronic Hepatitis C

Treatments: Drug: ChronVac-C + SOC; Drug: SOC

Study type: Interventional

Funder types: Industry

Identifiers

NCT01335711

2010-022960-10 (EudraCT Number)

CVC-202

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 35.
• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

32 participants in 4 patient groups

IMP_C/C IL28B

Experimental group

Description:

C/C IL28B subjects to whom IMP will be administrated prior to SOC

Treatment:

Drug: ChronVac-C + SOC

SOC_C/C IL28B

Active Comparator group

Description:

C/C IL28B subjects to whom only SOC will be administrated

Treatment:

Drug: SOC

IMP_non-C/C IL28B

Experimental group

Description:

non-C/C IL28B subjects to whom IMP will be administrated prior to SOC

Treatment:

Drug: ChronVac-C + SOC

SOC_non-C/C IL28B

Active Comparator group

Description:

non-C/C IL28B subjects to whom only SOC will be administrated

Treatment:

Drug: SOC