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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01506362 |
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Date of registration:
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03/01/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy, Pharmacodynamics, Safety and Tolerability of Oral BL-7040 in Patients With Moderately Active Ulcerative Colitis
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Scientific title:
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An Open-Label Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of Oral BL-7040 in Patients With Moderately Active Ulcerative Colitis |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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22 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01506362 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Israel
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Contacts
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Name:
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Eran Goldin, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shaare Zedek Medical Center |
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Name:
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Alex Fisch, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Soroka Medical Center |
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Name:
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Sigal Fishman, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sourasky Medical Center |
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Name:
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Eran Israeli, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hadassah medical center |
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Name:
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Yehuda Chowers, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rambam Health Care Campus |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Male or female, age 18 to 70.
2. Moderately active ulcerative colitis as defined by Mayo score of = 5 and = 9 within 9
days of first day of study treatment.
3. Diagnosis of ulcerative colitis = 3 months prior to study entry.
4. Endoscopic sub-score of = 2 and rectal bleeding sub-score of = 1 on the Mayo score and
endoscopic evidence of disease activity a minimum of 20 cm from the anal verge,
determined within 9 days of first day of study treatment.
5. Female patients must have a negative serum pregnancy test at screening and be willing
and able to use a medically acceptable method of birth control or declare that they
are abstaining from sexual intercourse, from the screening visit through the study
termination visit or be surgically sterile (bilateral tubal ligation, bilateral
oophorectomy, or hysterectomy) or post-menopausal. Postmenopausal women are defined as
women with menstruation cessation for 12 consecutive months prior to signing of the
informed consent form.
6. Ability and willingness to understand and comply with study procedures and to give
written informed consent prior to enrollment
Exclusion Criteria:
1. Diagnosis of indeterminate colitis or clinical findings suggestive of Crohn's disease.
2. Subjects with ulcerative proctitis.
3. A diagnosis of ischemic colitis, fulminant colitis or toxic megacolon.
4. Evidence of bowel infection.
5. Body temperature = 38°C at screening.
6. Evidence of abdominal abscess at the initial screening visit.
7. Extensive colonic resection, subtotal or total colectomy.
8. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
9. Receiving non-permitted IBD therapies
10. History of or current peptic ulcer disease.
11. Pregnant or lactating women.
12. Chronic hepatitis B or C infection or HIV seropositivity.
13. Current or recent history of severe, progressive, or uncontrolled renal, hepatic,
hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or
neurological disease.
14. Drug or alcohol abuse (by history).
15. Patients participating in any other clinical trials.
16. Patients with inability to communicate well with the Investigators and staff (i.e.,
language problem, poor mental development or impaired cerebral function).
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: BL-7040
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Primary Outcome(s)
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Proportion of Patients Who After Study Completion Achieve Clinical Response Defined by at Least a 3point Decrease & 30% Reduction From Baseline in Mayo Score Plus = 1 Point Decrease in Rectal Bleeding Sub-score or Absolute Rectal Bleeding Subscore of = 1
[Time Frame: From Baseline to day 34 (end of treatment period)]
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Secondary Outcome(s)
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Proportion of Patients With Mucosal Healing After Completion of Study Treatment Defined as Reduction in Endoscopy Subscore of = 1 From Baseline & an Absolute Endoscopy Subscore of = 1 Assessed by Flexible Sigmoidoscopy.
[Time Frame: 5 weeks following first administration]
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Secondary ID(s)
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BL-7040.01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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