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Trial registered on ANZCTR


Registration number
ACTRN12608000241336
Ethics application status
Not yet submitted
Date submitted
6/05/2008
Date registered
9/05/2008
Date last updated
9/05/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Asphelia Trichuris Suis Ova in Moderately Active Crohn's Disease
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Trial Of Asp1002 (Trichuris Suis Ova [Tso]) Therapy For Moderately Active Crohn’s Disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 3116 0
Condition category
Condition code
Oral and Gastrointestinal 3278 3278 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
15ml(167eggs/ml) oral Asp1002 (Trichuris Suis Ova [Tso]) taken every fortnight for 12 weeks.
Intervention code [1] 2860 0
Treatment: Drugs
Comparator / control treatment
The investigational placebo product is an aqueous suspension of phosphate-stabilized buffer (pH 3) in a volume of 15 (±1) ml.
Control group
Placebo

Outcomes
Primary outcome [1] 4176 0
percentage of patients who achieve response (reduction of CDAI[Crohn's Disease Activity Index] of ? 100 points) by Week 12,
Timepoint [1] 4176 0
no. of patients in remission at week 12 that remain in remission at week 24
Primary outcome [2] 4178 0
Primary Outcome: Safety and Tolerability of ASP1002 (TSO)
Timepoint [2] 4178 0
at week 12 and 24 after intervention commencement
Secondary outcome [1] 7059 0
time to response and remission
Timepoint [1] 7059 0
12 weeks post intervention
Secondary outcome [2] 7060 0
percentage of patients with healed ileal and colonic mucosa at Week 12 based on the Crohn?s disease endoscopic index of severity (CDEIS),
Timepoint [2] 7060 0
12 weeks post intervention
Secondary outcome [3] 7061 0
need for additional CD medications
Timepoint [3] 7061 0
12 weeks post intervention
Secondary outcome [4] 7063 0
To Evaluate Clinical Responseexamine immunological and inflammatory biomarkers, faecal samples and clinical response of ASP1002 (TSO)
Timepoint [4] 7063 0
At baseline and at week 12 and 24 after intervention commencement. 24 weeks

Eligibility
Key inclusion criteria
1. Diagnosis of CD involving the ileum, colon, or ileum and colon of
at least 6 months in duration as determined by medical history
2. CDAI (Crohn's Disease Activity Index)= 220 and = 350, as scored from 7 days during the
Screening period
3. Must have had colonoscopy with no significant findings and with
findings consistent with CD within 6 months of study entry
(Week 0)
4. Male or female, age 18 to 70 years, inclusive
5. If on the following medications at Screening Visit 1, patients must
meet the following criteria:
a. Corticosteroids: stable treatment for at least 4 weeks prior to
study entry (Week 0) with a maximum dose of 15 mg/day
b. Immunosuppressants [azathioprine (AZA),
6-mercaptopurine (6-MP), methotrexate (MTX)]: treatment
for at least 3 months with a stable dose for four weeks prior to
study entry (Week 0)
c. Antibiotics: ciprofloxacin can be continued at a stable dose
for up to two weeks if the patient is on treatment at Screening
Visit 1
d. Anti-inflammatory: Mesalamine can be continued if the
patient has been on a stable dose (up to 1.2 gms/daily) for 6
weeks prior to study entry (Week 0)


6. Able to read, understand, and sign an ethics committee approved
informed consent form
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients whose CD was diagnosed more than 5 years ago
2. Patients whose CD is anticipated to require surgical, endoscopic,
or radiologic intervention while on study
3. Hospitalization for CD within the last 2 months or at risk for
hospitalization secondary to CD within the next 2 months
4. CD requiring total parental nutrition (TPN)
5. Evidence of bowel obstruction within 3 months of Screening
6. Symptomatic stricture of the small or large intestine within 3
months of study entry (Week 0)
7. Active fistula not adequately drained or non-perianal fistula
8. Intestinal or abdominal abscess
9. History of bowel resection of any length in the last 6 months from
study entry (Week 0) or total bowel resection(s) > 100 cm.
Patients with total bowel resection(s) = 100 cm can be enrolled
provided that the Screening fecal calprotectin level is 100 mcg/g
feces to confirm that the bowel symptoms (i.e., diarrhea) are
linked to CD and not to short bowel syndrome.
10. Ileostomy or colostomy
11. Uncontrolled gastrointestinal (GI) bleeding
12. Short bowel syndrome
13. Diagnosis of ulcerative colitis
14. Scleroderma
15. Asthma necessitating daily controller medication
16. Clinically detectable splenomegaly
17. Positive stool culture for C difficile toxin A or B, bacterial enteric
pathogens, rotavirus, cryptosporidium species or pathogenic
ova/parasites
18. Co-infection with Campylobacter jejuni
19. Women, who are pregnant, breast feeding or planning to become
pregnant during the study. All women of childbearing potential
must have a negative serum pregnancy test prior to study entry
(Week 0)
20. Men and women of children bearing potential not using adequate
birth control measures (e.g., abstinence, oral contraceptives,
intrauterine device, barrier method with spermicide, or surgical
sterilization)
21. Current or recent serious systemic disorder including clinically
significant impairment in cardiac, pulmonary, liver, renal,
endocrine, hematologic, or neurologic function
22. Positive for human immunodeficiency virus (HIV)
23. Any condition associated with significant immunosuppression
24. Patients currently receiving the following concomitant
medications:
a. Prednisone or its equivalent, greater than 15 mg/day
b. Local steroids such as budesonide, Colifoam, and Predsol
enemas
c. Non-steroidal anti-inflammatory drugs (NSAIDS),
Cyclooxygenase (COX)-2 inhibitors, or aspirin
>100 mg/day within 1 week of study entry (Week 0)
d. TNF-alpha inhibitors such as infliximab (Remicade®),
adalimumab (Humira®) or other biological agents within 3
months of study entry (Week 0)
e. Metronidazole
25. Receipt of any investigational agent within the past 12 weeks
from study entry (Week 0)
26. Blood transfusion within the past 3 months from study entry
(Week 0)
27. Current or prior malignancy within five years, excluding non-
melanoma skin cancer, or precancerous dysplasia
28. Positive for Hepatitis BsAg or Hepatitis C antibody
29. Presence of the following abnormal laboratory parameters at
Screening:
a. Hemoglobin < 10.0 g/dL. The hemoglobin may be retested
one time prior to study entry (Week 0) if the first screening
test is < 10.0 g/dL
b. White blood Count (WBC) < 4,000 or > 20,000/mm3
c. Platelets < 100,000 or > 800,000/mm3
d. Amylase or lipase > 2 × upper limit of normal (ULN)
e. Total bilirubin > 1.5 × ULN
f. Alanine transaminase (ALT) and aspartate transaminase
(AST) > 2 × ULN
g. Alkaline phosphatase (ALK) or gamma glutamyl transferase
(GGT) > 1.5 × ULN
h. Creatinine > 1.5 × ULN
30. Known vitamin B12 deficiency (unless treated greater than one
month prior to study entry [Week 0])
31. Iron saturation level of less than 15%. The patient may be treated
and re-screened for participation provided that no iron
transfusions would be required during the study.
32. Current drug or alcohol abuse that may interfere with the
objectives of the study
33. Inability to comply with the planned schedule of study visits
34. Inability to understand the nature and requirements of the study,
or to comply with the study procedures
35. Any social or medical condition that, in the opinion of the
investigator, would preclude provision of informed consent, make
participation in the study unsafe, complicate interpretation of
study outcome data, or otherwise interfere with achieving the
study objectives.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Interactive Voice Response Randomisation system
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequencing There are no stratification factors planned for this randomization. Patients will be assigned a unique identification number. This randomisation assignment will not be revealed until the last patient has completed last visit at week 12
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 962 0
New Zealand
State/province [1] 962 0

Funding & Sponsors
Funding source category [1] 3358 0
Commercial sector/Industry
Name [1] 3358 0
Asphelia Pharmaceuticals Inc.
Country [1] 3358 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Asphelia Pharmaceuticals Inc.
Address
4365 Executive Drive, Suite 1500, San Diego, CA 92121
Country
United States of America
Secondary sponsor category [1] 3006 0
Commercial sector/Industry
Name [1] 3006 0
Novotech (Australia) Pty Ltd
Address [1] 3006 0
Level 3, 19 Harris Street, Pyrmont, NSW 2009
Country [1] 3006 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5384 0
Ethics committee address [1] 5384 0
Ethics committee country [1] 5384 0
Date submitted for ethics approval [1] 5384 0
14/05/2008
Approval date [1] 5384 0
Ethics approval number [1] 5384 0

Summary
Brief summary
Inflammatory bowel disease (IBD) is a chronic, relapsing condition of the gastrointestinal (GI) tract. IBD is thought to result from inappropriate T cell activation due to a combination of genetic and environmental factors. This leads to a deregulated immune response and characteristic inflammation. Crohn’s disease (CD) is a form of IBD.
One theory suggests that underexposure to helminths is a major environmental factor in predisposing to CD. This “hygiene hypothesis” is based on epidemiologic findings of an inverse relationship between IBD incidence and helminthic colonization.
In the proposed study, the pig whipworm Trichuris suis (T. suis), formulated as ASP1002 [Trichuris suis Ova (TSO)], a suspension for oral administration, will be administered in the clinic as a single dose for 6 times. T. suis is similar morphologically to the human whipworm but is cleared too rapidly from the human host to establish infection. Therefore, it has potential for being a natural immune modulator without significant risk of causing disease in humans.
The expected duration of study participation is approximately 26 to 27 weeks, including up to 2 - 3 weeks screening, a 12 week treatment period and a follow-up visit at Week 24.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28570 0
Address 28570 0
Country 28570 0
Phone 28570 0
Fax 28570 0
Email 28570 0
Contact person for public queries
Name 11727 0
Lena Chapman
Address 11727 0
Level 3, 19 Harris Street, Pyrmont, NSW 2009
Country 11727 0
Australia
Phone 11727 0
+61 (0) 2 85691400
Fax 11727 0
+61 (0) 2 8569 1498
Email 11727 0
[email protected]
Contact person for scientific queries
Name 2655 0
Xavier Frapaise
Address 2655 0
Asphelia Pharmaceuticals Inc. 4365 Executive Drive, Suite 1500, San Diego, CA 92121
Country 2655 0
United States of America
Phone 2655 0
+1 (0)858 7318520
Fax 2655 0
+1 (0)858 731-8501
Email 2655 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

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