NCT01025297

Brief 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.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_1

Geographic Reach
3 countries

8 active sites

Status
unknown

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

July 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

October 18, 2012

Status Verified

October 1, 2012

Enrollment Period

4.4 years

First QC Date

December 2, 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 1/2aviral diseaseliver disease

Outcome Measures

Primary Outcomes (1)

  • To evaluate at W 12 the safety of biologically active doses of CYT107 added to a combination therapy by pegylated interferon-alpha and ribavirin

    12 weeks after the start of IL-7

Secondary Outcomes (4)

  • To characterize pharmacokinetics and pharmacodynamics of CYT107

    12 weeks after the start of IL-7

  • To evaluate in the context of a dose escalation strategy the potential anti-viral effect of CYT107

    12 weeks after the start of IL-7

  • To evaluate the immune specific response to HCV

    12 weeks after the start of IL-7

  • To document the long-term safety and viral load variations

    48 weeks after the start of IL-7

Study Arms (1)

CYT107

EXPERIMENTAL
Drug: Interleukin-7

Interventions

Interleukin-7DRUG

3 dose levels: 3, 10 \& 20 µg/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 1 or 4 infected patients
  • Age \> 18 years
  • Absence of viral response to previous treatments with pegylated interferon-alpha plus ribavirin defined as:
  • Absence of early viral response (EVR) with detectable HCV and with a decrease HCV RNA load \< 2 logs, measured by a quantitative PCR tests after 12 weeks of treatment, as compared to baseline levels measured by a similar technique; or
  • Absence of end of treatment response defined by detectable HCV RNA at the end of treatment (24 weeks or 48 weeks)
  • Metavir ≤ F3 assessed by biopsy in the last 12 months or by fibroscan if Fibroscan® result \< 10 kPa in the last 6 months (biopsy can be avoided)

You may not qualify if:

  • Active infection by HBV (positive HBs Ag or positive anti HBc antibodies with a detectable HBV DNA viral load).
  • Infection by HIV-1 and /or HIV-2
  • Apart from HCV infection, presence of active infection requiring a specific treatment or a hospitalization
  • Other liver disease (notably from alcoholic, metabolic or immunological origin)
  • Body mass index (BMI) \> 30kg/m2
  • Relapse after previous response to pegylated IFN alpha and ribavirin therapy
  • Any history of malignancy apart from curatively treated basal cell carcinoma or in situ cervical carcinoma
  • History of clinical autoimmune disease or active auto-immune disease
  • History of severe asthma, presently on chronic medications
  • Significant cardiac or pulmonary disease
  • Prior solid organ or hematopoietic cell transplantation
  • Dialyzed patient
  • Inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

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

Fatebenefratelli e Oftalmico

Milan, 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

    Hospital of San Gallen-Switzerland

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 3, 2009

Study Start

July 1, 2008

Primary Completion

December 1, 2012

Study Completion

March 1, 2013

Last Updated

October 18, 2012

Record last verified: 2012-10

Locations

CH(1)FR(4)IT(3)