NCT01024894

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 Asiatic patients with Hepatitis C chronic infection identified as non responders to the standard bi-therapy alone.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
11 months 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
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 18, 2012

Status Verified

October 1, 2012

Enrollment Period

3.8 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 bitherapyimmune specific responses to HCVtaiwanphase 1/2aviral diseaseliver disease

Outcome Measures

Primary Outcomes (1)

  • safety of biologically active doses of CYT107 added to a combination therapy by pegylated interferon-alpha and ribavirin in Asian patients with a chronic infection by a genotype 1 HCV not responding to this combination therapy

    12 weeks after start of CYT107

Secondary Outcomes (4)

  • Pharmacokinetics and pharmacodynamics of CYT107 in this patients population.

    At short and mid terms follow-ups

  • potential anti-viral effect of CYT107

    4 weeks and 12 weeks after start of CYT107

  • long-term safety and viral load variations

    24 and 48 weeks after the start of CYT107

  • immune specific response to HCV

    8 and 12 weeks after start of CYT107

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:

  • HCV Genotype 1 infected patients
  • Absence of viral response to previous treatments with pegylated interferon-alpha plus ribavirin
  • Metavir ≤ F3 assessed by biopsy in the last 12 months

You may not qualify if:

  • Active 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
  • Other liver disease
  • Body mass index (BMI) \> 30kg/m2
  • Relapse after previous response to pegylated IFN alpha and ribavirin therapy
  • Previous bi-therapy with pegylated IFN alpha and ribavirin not well tolerated (in particular treatment discontinuation)
  • 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
  • Inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

Location

Chi Mei Medical Center

Tainan, Taiwan

Location

Cathay General Hospital

Taipei, 10650, Taiwan

Location

Chang Gung Memorial Hospital

Taipei, 33305, Taiwan

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

  • Wang-Long Chuang, MD

    Kaohsiung Medical University

    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 2, 2009

First Posted

December 3, 2009

Study Start

January 1, 2009

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

October 18, 2012

Record last verified: 2012-10

Locations

TW(4)