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

NCT01335711 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2011-10-12

No results posted yet for this study

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

Interventions

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)

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)

Sponsors & Collaborators

Principal Investigators

  • Ola RH Weiland, Professor · I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital, Huddinge, Sweden

  • Anders G Vahlne, Professor · ChronTech Pharma AB, Hälsovägen 7, SE-141 57 Huddinge, Sweden

  • Matti Sällberg, Professor · ChronTech Pharma AB, Hälsovägen 7, SE-141 57 Huddinge, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01335711 on ClinicalTrials.gov