NCT02185183

Brief Summary

Oral administration of Alequel, a mixture of proteins derived from the patient's bowel will be tested in patients with inflammatory bowel disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2008

Typical duration for phase_1

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, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
3 months until next milestone

Results Posted

Study results publicly available

September 22, 2014

Completed
Last Updated

October 1, 2014

Status Verified

January 1, 2008

Enrollment Period

2 years

First QC Date

April 28, 2014

Results QC Date

September 7, 2014

Last Update Submit

September 21, 2014

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Improved in Disease Activity

    15 weeks

Study Arms (1)

AlequelTM

EXPERIMENTAL

AlequelTM

Drug: Alequel

Interventions

AlequelDRUG

Alequel

AlequelTM

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Crohn's disease

You may not qualify if:

  • Immune suppression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Results Point of Contact

Title
Dr. Elazar Rabbani
Organization
ENZO
erabbani@enzo.com
2125830100

Study Officials

  • Yaron Ilan, M.D.

    Hadassah Medical Organization

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2014

First Posted

July 9, 2014

Study Start

January 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

October 1, 2014

Results First Posted

September 22, 2014

Record last verified: 2008-01