NCT01025596

Brief Summary

This study will evaluate the safety of a new experimental drug, IL-7, in people with HCV infection resistant after 12 weeks of bi-therapy.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2007

Longer than P75 for phase_1

Geographic Reach
3 countries

7 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

May 1, 2007

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

October 18, 2012

Status Verified

October 1, 2012

Enrollment Period

3.8 years

First QC Date

December 1, 2009

Last Update Submit

October 17, 2012

Conditions

Hepatitis C

Keywords

interleukin-7immune-based therapieshepatitis Cchronic hepatitisresistance to Peg-interferon and ribavirin bi-therapyimmune specific responses to HCVphase 1viral diseaseliver disease

Outcome Measures

Primary Outcomes (1)

  • Safety of biologically active doses of CYT107 added to a standard bi-therapy in patients with a chronic infection by a genotype 1 Hepatitis C Virus (HCV) not responding to this combination therapy 12 weeks after its initiation.

    8 weeks after start of CYT107

Secondary Outcomes (3)

  • Pharmacokinetics and pharmacodynamics of CYT107 in this patients population.

    As primary

  • potential anti-viral effect of CYT107

    As primary

  • immune specific response to HCV

    As primary

Study Arms (1)

CYT107

EXPERIMENTAL
Drug: Interleukin-7

Interventions

Interleukin-7DRUG

4dose levels: 3, 10, 20 and 30µg/kg. 4 administrations, 1 per week

CYT107

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Genotype I infected patients
  • Age \> 18 years
  • Absence of early viral response to a first treatment with PEG-interferon-alpha plus ribavirin given for at least 12 weeks. Absence of early viral response (EVR) will be defined as detectable HCV with a decrease HCV RNA load \< 2 logs, measured by a quantitative PCR tests, as compared to baseline levels measured by a similar technique
  • Ongoing treatment by PEG-interferon-alpha plus ribavirin at study entry

You may not qualify if:

  • Infection by HBV
  • Infection by HIV-1 and /or HIV-2
  • Apart from HCV infection, presence of active infection requiring a specific treatment or a hospitalization
  • Cirrhosis (Metavir F4) assessed by biopsy or FibroScan® or by liver biopsy within the last 6 months prior CYT107 treatment initiation. If assessed by Fibroscan® patients with a result \> 10 KPa will be excluded
  • Other liver disease (notably from alcoholic, metabolic or immunological origin)
  • Body mass index (BMI) \> 30kg/m2
  • Inability to give informed consent
  • Administration of growth factors (G-CSF, EPO) within the 12 weeks of the combination therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hopital Jean Verdier

Bondy, France

Location

Beaujon Hospital

Clichy, France

Location

Hopital Kremlin Bicêtre

Le Kremlin-Bicêtre, France

Location

Hopital Civil

Strasbourg, France

Location

Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola Malpighi

Bologna, Italy

Location

San Raffaele Scientific Institute

Milan, Italy

Location

University of Zurich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Hepatitis CHepatitis, ChronicVirus DiseasesLiver Diseases

Interventions

Interleukin-7

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanFlaviviridae InfectionsRNA Virus InfectionsHepatitisDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Tilman Gerlach

    University of Zurich / Saint Gallen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2009

First Posted

December 3, 2009

Study Start

May 1, 2007

Primary Completion

February 1, 2011

Study Completion

March 1, 2012

Last Updated

October 18, 2012

Record last verified: 2012-10

Locations

CH(1)FR(4)IT(2)