Condition category
Digestive System
Date applied
08/09/2005
Date assigned
20/02/2006
Last edited
09/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daniel Hommes

ORCID ID

Contact details

Academic Medical Center
Department of Gastroenterology
Room C2-330
Melbergdreef 9
Amsterdam
1105AZ
Netherlands
d.w.hommes@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00267709

Protocol/serial number

291-411

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the clinical activity of two consecutive daily doses of 10 µg/kg visilizumab administered intravenously to patients with draining perianal fistulas associated with Crohn's disease

Ethics approval

Ethics approval received from the Medical Ethics Committee on the 3rd February 2005 (ref: 04/318)

Study design

Treatment, non-randomised, open labelled, uncontrolled, single group assignment, efficacy study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

Crohn's disease

Intervention

Two consecutive daily doses of 10 µg/kg of visilizumab administered intravenously.

1. Taking of blood samples
2. Flexible sigmoidoscopy and biopsy
3. Magnetic resonance imaging (MRI) of fistulas

Intervention type

Drug

Phase

Phase II

Drug names

Visilizumab

Primary outcome measures

To evaluate the clinical activity of two consecutive daily doses of 10 µg/kg visilizumab administered intravenously to patients with draining perianal fistulas associated with Crohn's disease

Secondary outcome measures

1. To evaluate the pharmacokinetics of two consecutive doses of 10 µg/kg visilizumab administered intravenously in this patient population
2. To determine the risk-benefit relationship of visilizumab in this patient population
3. To assess immunogenicity of visulizumab in this patient population
4. To evaluate the safety, clinical activity, pharmacokinetics and immunogenicity of retreatment (if warranted) of two consecutive daily doses of 10 µg/kg visilizumab in patients with perianal fistulas associated with Crohn's disease

Overall trial start date

01/10/2004

Overall trial end date

31/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female, 18 to 70 years of age
2. A diagnosis of Crohn’s disease and at least one documented external, draining, perianal fistula
3. Patients with reproductive potential who agree to use double-barrier methods of contraception during the study and for three months after receiving the study drug
4. Women of childbearing potential who have a negative serum pregnancy test at baseline screening
5. Patients who have been tested negative for Clostridium difficile within three weeks prior to treatment with the study drug
6. Patients who are capable of understanding the purpose and risks of the study and who provide signed and dated informed consent and an authorisation to use protected health information (US sites only)
7. Patients who have Epstein-Barr virus (EBV) deoxyribonucleic acid (DNA) titres up to 30,000 copies/ml

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. History of lymphoproliferative disorder or a prior malignancy within five years or current malignancies (excluding non-melanoma skin cancers or in situ carcinoma of the cervix that had been adequately treated)
2. Pregnant women or nursing mothers
3. Any of the following haematological abnormalities: white blood cells (WBC) less than 2500/mm^3, platelets less than 150,000/mm^3, haemoglobin less than 10 g/dl
4. Serologic evidence of infection with human immunodeficiency virus (HIV) or hepatitis B or C virus (HBV or HCV)
5. Presence of obstructive symptoms, confirmed by endoscopy showing an impassable stricture or computed tomography (CT) or barium studies showing stricture with prestenotic bowel dilation, within six months prior to receiving study drug
6. Likely to require surgery in the next six months, such as those with clinically apparent abscesses or severely symptomatic stenoses (patients with fistula abscesses and/or setons at screening may be eligible for study entry if abscesses can be drained before patients receive study drug)
7. Serious infections, particularly those of viral etiology, e.g. known as active cytomegalovirus (CMV) colitis, and who have a history of opportunistic infections with the past year
8. Active infections that require antibiotic therapy (not to include use of antibiotics to manage Crohn’s disease)
9. Serious infections that require intravenous (IV) antibiotic therapy or hospitalisation within eight weeks prior to receiving study drug
10. Started, or have had a change of sulfasalazine; 5-aminosalicylic acid (5-ASA) or antibiotics, probiotics, or topical therapies for Crohn’s disease within two weeks prior to receiving the study drug
11. Had an increased dose of corticosteroid medication within two weeks prior to receiving the study drug, is receiving intravenous (IV) steroids, or, is receiving a daily dose of greater than 40 mg prednisone, greater than 9 mg budesonide or equivalent
12. Received a live vaccine within six weeks prior to receiving study drug (patients may not receive a live vaccine during treatment or for 12 weeks after treatment with the study drug)
13. Received any monoclonal antibodies (including infliximab) or investigational agents or biologics within three months prior to receiving the study drug
14. Received cyclosporine or tacrolimus (FK506) within four weeks of receiving the study drug
15. Had a dose change of, or discontinued from, 6-mercaptopurine, azathioprine or methatrexate within four weeks prior to receiving the study drug
16. Significant organ dysfunction, including cardiac, renal, liver, central nervous system (CNS), pulmonary, vascular, non-Crohn’s disease related gastrointestinal, endocrine or metabolic (e.g. creatinine greater than 1.6 mg/dl, alanine aminotranferease [ALT] and aspartate aminotransferase [AST] greater than twice the upper limit of normal [ULN], alkaline phosphatase greater than 1.5 x ULN, history of myocardial infarction, congestive heart failure or arrhythmias within six months prior to study entry)
17. History of proliferative disorder
18. History of tuberculosis (TB) or other mycobacterial infection, or chest X-ray positive for previous TB infection
19. History of thrombophlebitis or pulmonary embolus
20. Histories of immune deficiency or autoimmune disorders other than Crohn’s disease (not including joint, skin, hepatic, and occular inflammatory conditions that may be components of Crohn’s disease)
21. History of seizure with subtherapeutic blood levels of anticonvulsive medication (documented) within one week before study enrolment

Recruitment start date

01/10/2004

Recruitment end date

31/08/2007

Locations

Countries of recruitment

Austria, Belgium, Germany, Netherlands, United States of America

Trial participating centre

Academic Medical Center
Amsterdam
1105AZ
Netherlands

Sponsor information

Organisation

PDL BioPharma Inc. (USA)

Sponsor details

34801 Campus Drive
Fremont
94587
United States of America
mdyer@pdl.com

Sponsor type

Industry

Website

http://www.pdl.com/

Funders

Funder type

Industry

Funder name

PDL BioPharma Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes