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Phase I/IIa Dose Ranging CHRONVAC-C® Study in Chronic HCV Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Tripep AB.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Inovio Pharmaceuticals
Information provided by:
Tripep AB
ClinicalTrials.gov Identifier:
NCT00563173
First received: November 23, 2007
Last updated: February 9, 2010
Last verified: February 2010
  Purpose

The purpose of this study is to evaluate if the DNA vaccine CHRONVAC-C® intended for future treatment of Hepatitis C infections is safe and tolerated when administered to HCV infected individuals with a low viral load. In addition the capability of the vaccine to induce an immune response and the effect on viral load will be studied. In order to increase the uptake of the vaccine the intra muscular injection is combined with electroporation, meaning that a brief electric field is applied to the injection site resulting in temporary pores in the cell membranes that allows the vaccine to enter the cells.


Condition Intervention Phase
Chronic Hepatitis C Virus Infection
Drug: CHRONVAC-C®
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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 HCV Genotype 1 Infected and Treatment Naïve Patients With Low Viral Load

Resource links provided by NLM:


Further study details as provided by Tripep AB:

Primary Outcome Measures:
  • To evaluate safety and tolerability of electroporation mediated i.m. delivery of CHRONVAC-C® in chronically HCV infected, treatment naive patients with low viral load. [ Time Frame: From start of treatment to 24 weeks post treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To provide information regarding dose related anti-viral immune response and dose related effect on viral load. [ Time Frame: From start of treatment to 24 weeks post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: October 2007
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Low dose
Drug: CHRONVAC-C®
DNA vaccine, solution for injection, i.m. administration in combination with electroporation
2
Medium dose
Drug: CHRONVAC-C®
DNA vaccine, solution for injection, i.m. administration in combination with electroporation
3
High dose
Drug: CHRONVAC-C®
DNA vaccine, solution for injection, i.m. administration in combination with electroporation

  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 patient 18 -65 years of age with a known chronic hepatitis C infection.
  • Genotype 1 infection.
  • Viral load equal to or less than 800.000 IU/mL.
  • BMI less than 30.
  • 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.
  • Written informed consent obtained, and a copy provided to the patient.
  • Patient legally competent and able to communicate effectively with the study personnel.
  • Patient likely to co-operate and attend the clinic at the appointed times during the study.

Exclusion Criteria:

  • Patient having clinically significant concomitant diseases other than HCV in the medical history to the discretion of the investigator.
  • Patient having clinically significant findings on physical examination, vital signs, ECG or clinical laboratory evaluations to the discretion of the investigator.
  • Patient having clinical or biochemical signs of cirrhosis.
  • Positive hepatitis B surface antigen (HBsAg).
  • Positive HIV antigen or antibody test.
  • Patient having an ongoing and/or known viral infection other than HCV that requires treatment and/or special medical intention.
  • Patient 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.
  • Treatment with NSAID within 10 days of the first dose of study drug.
  • Immunization within 30 days of the first dose of the study drug.
  • 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.
  • Prior treatment with DNA therapy.
  • Known allergy towards vaccines.
  • 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 patient who is breast feeding.
  • 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.
  • Patient with a positive urine pregnancy test.
  • Male patient unwilling to use condom for active prevention of pregnancy from first vaccination to 4 months after last injection.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563173

Locations
Sweden
Department of Gastroenterology and Hepatology, Karolinska University Hospital, Solna
Stockholm, Sweden, SE-171 76
I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital, Huddinge
Stockholm, Sweden, SE-141 86
Sponsors and Collaborators
Tripep 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 Vahlne, Professor Tripep AB
Study Director: Matti Sällberg, Professor Tripep AB
  More Information

No publications provided

Responsible Party: Prof. Anders Vahlne/CEO, Tripep AB
ClinicalTrials.gov Identifier: NCT00563173     History of Changes
Other Study ID Numbers: CVC-201, EudraCT No. 2007-002901-33
Study First Received: November 23, 2007
Last Updated: February 9, 2010
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Virus Diseases
Digestive System Diseases
Flaviviridae Infections
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections

ClinicalTrials.gov processed this record on November 25, 2014