NCT00601770

Brief Summary

The objective is to investigate the virological (HCV-RNA) responses following biweekly immunization with IC41. Treatment phase 14 weeks, total study duration including follow-up period 38 weeks.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2006

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2008

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

February 11, 2014

Status Verified

February 1, 2014

Enrollment Period

2.4 years

First QC Date

January 4, 2008

Last Update Submit

February 10, 2014

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • HCV-RNA 2 weeks after end of treatment

    2 weeks

Secondary Outcomes (1)

  • Immunological assays and Safety

    until study end

Study Arms (1)

IC41

EXPERIMENTAL

8 injections of 4 x 0.125mL

Biological: IC41

Interventions

IC41BIOLOGICAL

injection

IC41

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent obtained prior to study entry
  • Patients with chronic hepatitis C; genotype 1
  • Treatment naive patients
  • Male and Female, 18 to 55 years
  • Presence of HLA-A2 marker
  • Mentally healthy
  • No clinically relevant pathological findings in any of the investigations at screening
  • Treatment naive patients with chronic Hepatitis C of genotype 1

You may not qualify if:

  • Positive results in HIV, HBsAg and HAV-Ag (IgM)
  • Other causes of chronic hepatitis
  • History of autoimmune diseases
  • Previous vaccination with any prophylactic or therapeutic Hepatitis C vaccine (in a clinical study)
  • Active or passive vaccination 4 weeks before and during the entire study period
  • Decompensated liver disease
  • History of severe hypersensitivity reactions and anaphylaxis
  • Known allergic reactions to one of the components of the vaccine and Imiquimod cream
  • Clinically significant diseases which, in the opinion of the Investigator, might lead to frequent hospitalization/medical attendance
  • Malignancies
  • Immunosuppressive therapy
  • Pregnancy, lactation or breast-feeding
  • Unwillingness to practice appropriate contraception
  • Participation in another study with an investigational drug within 1 month prior to enrolment and the entire study period
  • Patients, who in the opinion of the Investigator, might not be able to comply with the study protocol (e.g.: Drug addiction, alcoholism)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Prof. Dr. Ulrich Spengler

Bonn, Bonn, 53105, Germany

Location

Prof. Dr. Michael Manns

Hanover, Hannover, 30625, Germany

Location

Dr. Granzyna Cholewinska-Szymanska

Warzawa, Warzawa, 01201, Poland

Location

Prof. Dr. Andrzej Gladszy

Wroclaw, Wroclaw, 51149, Poland

Location

Prof. Dr. Mircea Diculescu

Bucharest, Bucharest, 11461, Romania

Location

Dr. Adriana Motoc

Bucharest, Bucharest, 30303, Romania

Location

Dr. Adriana Hristea

Bucharest, Bucharest, 72204, Romania

Location

Prof. Dr. Carol Stanciu

Iași, Iaşi, 700111, Romania

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sonja Ernsthofer, Mag

    Valneva Austria GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2008

First Posted

January 28, 2008

Study Start

February 1, 2006

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

February 11, 2014

Record last verified: 2014-02

Locations

RO(4)PL(2)DE(2)