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IC41

Phase 2

Chronic Hepatitis C | Monoclonal antibody | Infectious Disease |Valneva SE|Last Updated: Feb 11, 2014

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment137

FDA Designations

No designations recorded

Clinical trial landscape

IC41 · 2 trials · 1 indication

Phase 2 2
NCT00601770Virological Response Study of the HCV Vaccine IC41Chronic Hepatitis C
COMPLETED71 Analytics
NCT00602784Phase II Study of Immunization With a Hepatitis C Virus (HCV) Antigen Peptide VaccineChronic Hepatitis C
COMPLETED66 Analytics
PHASE2COMPLETED
Virological Response Study of the HCV Vaccine IC41
Chronic Hepatitis CUnlock trial analytics
PHASE2COMPLETED
Phase II Study of Immunization With a Hepatitis C Virus (HCV) Antigen Peptide Vaccine
Chronic Hepatitis CUnlock trial analytics

Study Endpoints

Primary Endpoints

HCV-RNA 2 weeks after end of treatment
2 weeks
Immunological assays
study duration

Secondary Endpoints

Immunological assays and Safety
until study end
Safety
study duration
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IC41EXPERIMENTAL8 injections of 4 x 0.125mL
IC41-B-01/02EXPERIMENTALpeptide dose 0.00 mg, polyarginine dose 2.00 mg
IC41-C-01/02EXPERIMENTALpeptide dose: 5.00 mg, polyarginine dose: 0.00 mg
IC41-G-01/02EXPERIMENTALpeptide dose: 2.50 mg, polyarginine dose: 1.25 mg
IC41-H-01/02EXPERIMENTALpeptide dose: 2.50 mg, polyarginine dose: 2.00 mg
IC41-K-01/02EXPERIMENTALpeptide dose: 5.00 mg, polyarginine dose: 2.00 mg

Interventions

NameTypeDescription
IC41BIOLOGICALinjection
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * 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 inves...

Countries:GermanyPolandRomania
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Frequently asked questions about IC41

What is IC41 used for?

IC41 is an investigational therapeutic vaccine being developed for chronic hepatitis C. It is designed to treat patients with this viral infection. The drug is currently in clinical development and has completed Phase 2 trials, but it is not yet approved for use.

Who makes IC41?

IC41 is being developed by Valneva SE, a biopharmaceutical company. Valneva's stock is traded under the ticker symbol VALN. The company is conducting clinical trials to evaluate the safety and efficacy of IC41 in patients with chronic hepatitis C.

What phase is IC41 in?

IC41 is in Phase 2 clinical development. Two Phase 2 trials have been completed, with a total of 137 participants enrolled. The drug is still investigational and has not received regulatory approval for the treatment of chronic hepatitis C.

What clinical trials is IC41 in?

IC41 has been studied in two completed Phase 2 clinical trials. The first trial, NCT00601770, enrolled 71 participants and was conducted in Germany, Poland, and Romania. The second trial, NCT00602784, enrolled 66 participants. Both trials focused on chronic hepatitis C.

Is IC41 a monoclonal antibody?

IC41 is classified as a monoclonal antibody in the available data. However, it is being studied as a therapeutic vaccine for chronic hepatitis C. The drug is administered to stimulate an immune response against the hepatitis C virus.