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Dose Escalation Study of Interleukin-7 (IL-7) and Bitherapy in HCV Genotype 1 or 4 Patients Resistant to Bitherapy Alone

NCT01025297 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2012-10-18

No results posted yet for this study

Summary

This study is designed to evaluate the safety of biological active dose of a new experimental drug, IL-7, in combination with standard bi-therapy in patients with Hepatitis C chronic infection identified as non responders to the standard bi-therapy alone.

Conditions

  • Hepatitis C

Interventions

DRUG

Interleukin-7

3 dose levels: 3, 10 \& 20 µg/kg. 4 administrations, 1 per week

Sponsors & Collaborators

  • Cytheris SA

    lead INDUSTRY

Principal Investigators

  • Tilman Gerlach · Hospital of San Gallen-Switzerland

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2012-12-31
Completion
2013-03-31

Countries

  • France
  • Italy
  • Switzerland

Study Locations

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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 NCT01025297 on ClinicalTrials.gov