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

NCT01335711 | Unknown Phase 2 DMC

• 2 other identifiers: CVC-2022010-022960-10
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (4)

• Early viral kinetics - Second phase slope of viral decline

  0-4 weeks after SOC onset

• Rapid Viral Response (RVR). Percent subjects reaching non-detectable level of HCV-RNA.

  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.

  12 weeks after SOC onset

• Complete Early Viral Response (cEVR). Percent subjects reaching non-detectable level of HCV-RNA.

  12 weeks after SOC onset

Secondary Outcomes (5)

• Local tolerance

  up to 12 weeks after SOC onset

• 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

Study Arms (4)

IMP_C/C IL28B

EXPERIMENTAL

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

Drug: ChronVac-C + SOC

SOC_C/C IL28B

ACTIVE COMPARATOR

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

Drug: SOC

IMP_non-C/C IL28B

EXPERIMENTAL

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

Drug: ChronVac-C + SOC

SOC_non-C/C IL28B

ACTIVE COMPARATOR

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

Drug: SOC

Interventions

ChronVac-C + SOC DRUG

IMP: I.m. administration of 500 μg plasmid DNA vaccine CHRONVAC-C (solution for injection) administered i.m. in combination with electroporation using MedPulser® DDS on 2 occasions with 4 weeks in between followed by standard of care (SOC) initiation after 14 - 42 days. SOC: Peg-IFN-α-2a (180 μg per week) and Ribavirin (1000 mg/day for subjects with a BW of \< 75 kg and 1200 mg/day for subjects with a BW of \> 75 kg)

IMP_C/C IL28B; IMP_non-C/C IL28B

SOC DRUG

SOC: Peg-IFN-α-2a (180 μg per week) and Ribavirin (1000 mg/day for subjects with a BW of \< 75 kg and 1200 mg/day for subjects with a BW of \> 75 kg)

SOC_C/C IL28B; SOC_non-C/C IL28B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ChronTech Pharma AB: lead
• Inovio Pharmaceuticals: collaborator

Study Sites (2)

I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital

Huddinge, SE-141 86, Sweden

RECRUITING

Division of Infectious Diseases, Department of Clinical and experimental medicine, Faculty of Health Sciences, Linköping University, Department of Infectious Diseases, County Council of Östergötland

Linköping, SE-581 85, Sweden

RECRUITING

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ola RH Weiland, Professor

  I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital, Huddinge, Sweden

  PRINCIPAL INVESTIGATOR

• Anders G Vahlne, Professor

  ChronTech Pharma AB, Hälsovägen 7, SE-141 57 Huddinge, Sweden

  STUDY CHAIR

• Matti Sällberg, Professor

  ChronTech Pharma AB, Hälsovägen 7, SE-141 57 Huddinge, Sweden

  STUDY DIRECTOR

Central Study Contacts

Ola RH Weiland, Professor

CONTACT

+46 (8) 585 800 00; ola.weiland@ki.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: April 14, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

SE (2)