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

Purpose

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.

Condition	Intervention	Phase
Chronic Hepatitis C	Drug: ChronVac-C + SOC Drug: SOC	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Open-Label, Randomized, Parallel Group, Safety, Tolerability and Efficacy Study of i.m. Administered CHRONVAC-C in Combination With Electroporation Followed by Standard of Care in Chronic Hepatitis C Virus Genotype 1 Infected and Treatment Naïve Subjects

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

U.S. FDA Resources

Further study details as provided by ChronTech Pharma AB:

Primary Outcome Measures:

Early viral kinetics - Second phase slope of viral decline [ Time Frame: 0-4 weeks after SOC onset ] [ Designated as safety issue: No ]
Rapid Viral Response (RVR). Percent subjects reaching non-detectable level of HCV-RNA. [ Time Frame: 4 weeks after SOC onset ] [ Designated as safety issue: No ]
Partial Early Viral Response (pEVR). Percent HCV-RNA positive subjects with more than 2 log 10 decline in HCV-RNA. [ Time Frame: 12 weeks after SOC onset ] [ Designated as safety issue: No ]
Complete Early Viral Response (cEVR). Percent subjects reaching non-detectable level of HCV-RNA. [ Time Frame: 12 weeks after SOC onset ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Local tolerance [ Time Frame: up to 12 weeks after SOC onset ] [ Designated as safety issue: Yes ]
Local tolerance will be measured for subjects randomized to vaccination. Local tolerance will be measured 3 times during a time period of 2 h post vaccination. The site of injection will also be inspected at the following visits.
Change from baseline in vital signs [ Time Frame: 0 - 12 weeks ] [ Designated as safety issue: Yes ]
Number of patients with AEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Change of blood status from baseline [ Time Frame: 0 - 12 weeks ] [ Designated as safety issue: Yes ]
Exploratory Analysis - Characterization and quantification of the vaccine primed NS3-immune response [ Time Frame: 0 - 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	32
Study Start Date:	April 2011
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: IMP_C/C IL28B C/C IL28B subjects to whom IMP will be administrated prior to SOC	Drug: ChronVac-C + SOC 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)
Active Comparator: SOC_C/C IL28B C/C IL28B subjects to whom only SOC will be administrated	Drug: SOC 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)
Experimental: IMP_non-C/C IL28B non-C/C IL28B subjects to whom IMP will be administrated prior to SOC	Drug: ChronVac-C + SOC 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)
Active Comparator: SOC_non-C/C IL28B non-C/C IL28B subjects to whom only SOC will be administrated	Drug: SOC 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)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335711

Contacts

Contact: Ola RH Weiland, Professor

+46 (8) 585 800 00

ola.weiland@ki.se

Locations

Sweden
I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital	Recruiting
Huddinge, Sweden, SE-141 86
Contact: Ola RH Weiland, Professor +46 (8) 585 800 00 ola.weiland@ki.se
Principal Investigator: Ola RH Weiland, Professor
Division of Infectious Diseases, Department of Clinical and experimental medicine, Faculty of Health Sciences, Linköping University, Department of Infectious Diseases, County Council of Östergötland	Recruiting
Linköping, Sweden, SE-581 85
Contact: Kristina Cardell, MD +46 (0)10 103 00 00 kristina.cardell@lio.se
Principal Investigator: Kristina Cardell, MD

Sponsors and Collaborators

ChronTech Pharma AB

Inovio Pharmaceuticals

Investigators

Principal Investigator:	Ola RH Weiland, Professor	I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital, Huddinge, Sweden
Study Chair:	Anders G Vahlne, Professor	ChronTech Pharma AB, Hälsovägen 7, SE-141 57 Huddinge, Sweden
Study Director:	Matti Sällberg, Professor	ChronTech Pharma AB, Hälsovägen 7, SE-141 57 Huddinge, Sweden

More Information

No publications provided

Responsible Party:	ChronTech Pharma AB
ClinicalTrials.gov Identifier:	NCT01335711 History of Changes
Other Study ID Numbers:	CVC-202, 2010-022960-10
Study First Received:	April 13, 2011
Last Updated:	October 11, 2011
Health Authority:	Sweden: Medical Products Agency

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases

Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 23, 2013