NCT01316601

Brief Summary

Test safety and efficacy and of a novel IL-13 AB in the treatment of perianal fistulas

  • Trial with medicinal product

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

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

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

1.8 years

First QC Date

March 14, 2011

Last Update Submit

May 27, 2015

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

  • complete closure of fistula

Interventions

QAX567DRUG

Eligibility Criteria

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

You may not qualify if:

  • \- planned surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Zurich, Switzerland

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • 01 Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.Dr.Dr. Gerhard Rogler

Study Record Dates

First Submitted

March 14, 2011

First Posted

March 16, 2011

Study Start

January 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

CH(1)