NCT00353756

Brief Summary

The purpose of this study is to determine whether C326, a new inhibitor of IL-6, is safe in patients with Crohn's disease.

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
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

2 active sites

Status
unknown

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

July 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

October 11, 2006

Status Verified

September 1, 2006

First QC Date

July 17, 2006

Last Update Submit

October 10, 2006

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

  • Safety evaluations

Secondary Outcomes (3)

  • Pharmacokinetics

  • Biomarker changes -- IL-6, CRP and other acute phase reactants

  • Crohn's Disease Activity Index (CDAI)

Interventions

C326, IL-6 Inhibitory Avimer proteinDRUG

Eligibility Criteria

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

You may qualify if:

  • Adults 18 - 65
  • Stable, moderately active Crohn's Disease
  • Otherwise in generally good health

You may not qualify if:

  • Variety of concurrent medical conditions
  • Various concomitant medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

QPharm

Brisbane, Queensland, Australia

RECRUITING

Center for Clinical Studies

Melbourne, Victoria, Australia

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Lee Min Yap, MD

    Alfred Hospital, Melbourne, Australia

    PRINCIPAL INVESTIGATOR

  • Graham Radford-Smith, MD

    Royal Brisbane and Womens Hospital, Brisbane, Australia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabrielle McKee

CONTACT

61 (0)7 3331 3933Gabrielle.McKee@clinetserv.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 17, 2006

First Posted

July 19, 2006

Study Start

September 1, 2006

Study Completion

September 1, 2007

Last Updated

October 11, 2006

Record last verified: 2006-09

Locations

AU(2)