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Register:	EUCTR
Last refreshed on:	13 May 2024
Main ID:	EUCTR2006-000197-69-CZ
Date of registration:	10/03/2006
Prospective Registration:	Yes
Primary sponsor:	AM-Pharma B.V.
Public title:	A pilot, open-label, multi-center clinical trial to investigate the safety and efficacy of Bovine-Calf Intestinal Alkaline Phosphatase in patients with moderate to severe ulcerative colitis
Scientific title:	A pilot, open-label, multi-center clinical trial to investigate the safety and efficacy of Bovine-Calf Intestinal Alkaline Phosphatase in patients with moderate to severe ulcerative colitis
Date of first enrolment:	30/05/2006
Target sample size:	24
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000197-69
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: no Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment
Czech Republic	Italy

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
· age ³ 18 years, and
· capable of understanding the purpose and risks of the study and have provided a signed and dated written informed consent,

and·

prior to the study baseline, been treated with oral steroid medication, of which > 2 weeks on oral prednisone equivalent of at least 40 mg/day, and still have: § active ulcerative colon disease documented by a MAYO-score of 6-11, and§ active ulcerative colon disease documented by a MTWSI score of 7-15

or
· prior to the study baseline, documented clinical inability to decrease or stop the course of oral steroid medication. Patients have been treated for a minimum of 12 weeks, and still have:
§ chronic active ulcerative colon disease documented by a MAYO-score of 6-11,
and§ chronic active ulcerative colon disease documented by a MTWSI score of 7-15

or
· prior to the study baseline, been treated with a stable dosage of azathioprine for a minimum of 12 weeks, and have a moderate to severe relapse defined as:§ chronic active ulcerative colon disease documented by a MAYO-score of 6-11, andchronic active ulcerative colon disease documented by a MTWSI score of 7-15
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
§ ulcerative colitis, requiring immediate surgical, endoscopic, or radiological intervention;
· history of large bowel surgery
· history of serious infections
· positive stool cultures, including Clostridium Difficile
· significant organ dysfunction
· pregnancy, nursing mothers, or women of childbearing potential without appropriate use of contraceptives
· treatment with:
1. an altered dose of any 5-ASA preparation within 4 weeks of screening
2. an altered dose of azathioprine or mercaptopurine within 4 weeks of screening (stable dosage of immunosuppressives is allowed), or start of azathioprine in the last 3 months prior to baseline
3. probiotics, antibiotics, methotrexate or cyclosporine within 1 month resp. 2 months prior of screening
4. any experimental treatment for this population e.g. infliximab, tacrolimus, FK506 or other anti TNF-a therapy) within 2 months of screening

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Inflammatory Bowel Disease

Intervention(s)

Product Name: Bovine-Calf Alkaline Phosphatase (BIAP)
Pharmaceutical Form: Concentrate for solution for infusion

Primary Outcome(s)

Primary end point(s): To investigate the safety and tolerability of 7 days of BIAP administration in patients with moderate to severe ulcerative colitis
Safety variables
Evaluation of circulating antibodies against BIAP, via ELISA
Clinical labs (hematology/chemistry incl. cytokines/urine)
Vital signs, physical examinations
Adverse event monitoring.

Secondary Objective: To investigate the efficacy of BIAP in patients with moderate to severe ulcerative colitis.

Main Objective: To investigate the safety and tolerability of BIAP in patients with moderate to severe ulcerative colitis.

Secondary Outcome(s)

Secondary ID(s)

AP IBD 02-02

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 20/04/2006
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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