NCT00252369

Brief Summary

This study is aimed to assess the hypothesis that instillation of fibrin glue with the induction of local conditions using Infliximab, may be useful in the treatment of perianal Crohn's disease.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

4 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

November 10, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2005

Completed
Last Updated

April 24, 2009

Status Verified

April 1, 2009

First QC Date

November 10, 2005

Last Update Submit

April 23, 2009

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

  • Fistula healing

Secondary Outcomes (2)

  • Quality of life

  • Complications

Interventions

InfliximabDRUG
Instillation of fibrin gluePROCEDURE

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Perianal fistula of Crohn's dis

You may not qualify if:

  • More then 2 fistulae perianal sepsis known contraindication to infliximab or glue

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Meir Medical Center

Kfar Saba, Israel

Location

Tel Aviv Medical Center

Tel Aviv, Israel

Location

Sheba Medical Center

Tel Litwinsky, Israel

Location

Assaf Harofe Medical Center

Zrifin, Israel

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Oded Zmora, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 10, 2005

First Posted

November 11, 2005

Last Updated

April 24, 2009

Record last verified: 2009-04

Locations

IL(4)