NCT00451932

Brief Summary

A proof of concept study to evaluate the safety and effectiveness of FK778 in liver transplant patients.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
303

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2002

Typical duration for phase_2

Geographic Reach
12 countries

29 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

October 1, 2002

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2007

Completed
Last Updated

April 17, 2008

Status Verified

April 1, 2008

Enrollment Period

2.9 years

First QC Date

March 23, 2007

Last Update Submit

April 15, 2008

Conditions

Liver Transplantation

Keywords

MalononitrilamideImmunosuppressiontreatment efficacytreatment effectiveness

Outcome Measures

Primary Outcomes (1)

  • Event rate of biopsy-proven acute rejections

Secondary Outcomes (1)

  • Incidence of adverse events

Interventions

FK778DRUG

Eligibility Criteria

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

You may qualify if:

  • Male or female patients at least 18 years of age and not older than 65 years.
  • Female patients of child bearing potential must have a negative serum pregnancy test prior to enrollment and must agree to practice effective birth control during the study.
  • Male patients must agree to practice effective birth control methods during the study.
  • Patient is a recipient of a primary whole cadaveric liver transplant

You may not qualify if:

  • Patient has previously received or is receiving an organ transplant other than a liver.
  • Patient has received an ABO incompatible donor liver.
  • Patient or donor is known to be HIV positive.
  • Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
  • Patient is being transplanted for hepatic malignancy with a single nodule greater than 5.0 cm in diameter or 2 or more nodules with at least one \> 3.0 cm.
  • Patient has a serum creatinine \>175 µmol/L at baseline. Patient has uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any other unstable medical condition that could interfere with the study objectives.
  • Patient who is receiving or may require warfarin or fluvastatin during the study.
  • Patient is participating in another clinical trial and/or is taking or has been taking an investigational drug in the 28 days prior to transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Unknown Facility

Innsbruck, Austria

Location

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Edmonton, Alberta, Canada

Location

Unknown Facility

London, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Unknown Facility

Brno, Czechia

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Clichy, France

Location

Unknown Facility

Lyon, France

Location

Unknown Facility

Montpellier, France

Location

Unknown Facility

Rennes, France

Location

Unknown Facility

Strasbourg, France

Location

Unknown Facility

Villejuif, France

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Essen, Germany

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Hanover, Germany

Location

Unknown Facility

Budapest, Hungary

Location

Unknown Facility

Milan, Italy

Location

Unknown Facility

Udine, Italy

Location

Unknown Facility

Rotterdam, Netherlands

Location

Unknown Facility

Barakaldo, Spain

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Santiago de Compostela, Spain

Location

Unknown Facility

Zurich, Switzerland

Location

Unknown Facility

Birmingham, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

MeSH Terms

Interventions

2-cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)-2-hepten-6-ynamide

Study Officials

  • Use Central Contact

    Universitätsklinik Charité

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 23, 2007

First Posted

March 26, 2007

Study Start

October 1, 2002

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

April 17, 2008

Record last verified: 2008-04

Locations

IT(2)CH(1)AU(1)DE(4)HU(1)FR(6)BE(2)CZ(2)ES(4)NL(1)GB(2)CA(3)