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Safety and Tolerability of Single Doses Oral CNDO 201 Trichuris Suis Ova in Patients With Crohn's Disease

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ClinicalTrials.gov Identifier: NCT01434693
Recruitment Status : Completed
First Posted : September 15, 2011
Results First Posted : May 20, 2013
Last Update Posted : May 20, 2013
Sponsor:
Information provided by (Responsible Party):
Coronado Biosciences, Inc.

Tracking Information
First Submitted Date  ICMJE September 13, 2011
First Posted Date  ICMJE September 15, 2011
Results First Submitted Date  ICMJE February 26, 2013
Results First Posted Date  ICMJE May 20, 2013
Last Update Posted Date May 20, 2013
Study Start Date  ICMJE November 2011
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2013)
Incidence of Adverse Events [ Time Frame: 6 mo ]
Comparison of safety and tolerability was performed across the dose levels by evaluating the post-dose tolerability of TSO in patients with Crohn's Disease via incidence of adverse events (i.e. # events) with a specific focus on reported gastrointestinal signs and symptoms
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2011)
To evaluate, in a sequential dose escalation manner, the safety and tolerability of single doses of 3 doses levels (500, 2500, and 7500 embryonated) oral Trichuris suis ova suspension (TSO), as compared to placebo, in patients with Crohn's Disease [ Time Frame: 6 mo ]
Comparison of safety and tolerability will be performed across the dose levels by evaluating the post-dose tolerability of TSO in patients with Crohn's Disease via incidence of adverse events with a specific focus on reported gastrointestinal signs and symptoms
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of Single Doses Oral CNDO 201 Trichuris Suis Ova in Patients With Crohn's Disease
Official Title  ICMJE A Sequential Dose-Escalation, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate the Safety and Tolerability of Single Doses of 3 Different Doses of Oral CNDO 201 Trichuris Suis Ova Suspension (Tso) in Patients With Crohn's Disease
Brief Summary This is a sequential dose-escalation (with up to 3 dose levels of TSO, ie, 500, 2500, and 7500 TSO), randomized (within each of 3 periods, with a ratio of 3:1 for TSO to placebo), double-blind, placebo-controlled study to evaluate the safety of a single dose of oral CNDO-201 Trichuris suis ova suspension, as compared to placebo, in patients with Crohn's Disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Biological: Trichuris suis ova
    single dose
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: TSO 500
    Intervention: Biological: Trichuris suis ova
  • Experimental: TSO 2500
    Intervention: Biological: Trichuris suis ova
  • Experimental: TSO 7500
    Intervention: Biological: Trichuris suis ova
  • Placebo Comparator: Placebo
    single dose
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2011)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males or females, 18 to 55 years old.
  2. Patient has confirmed diagnosis of Crohn's Disease by established criteria with a minimum disease duration of 3 months.
  3. If patient is using concomitant medications, the dose/regimen is stable and remains stable for the two weeks of close observation following TSO administration. Concomitant medications may include: 1) Oral sulfasalazine, mesalazine (5-ASA), or mesalazine derivative, if receiving it for >6 weeks and if receiving the same dose for at least 4 weeks; 2) Oral prednisone up to 15 mg/day, if receiving it for >4 weeks and if receiving the same dose for at least 2 weeks; and 3) Azathioprine or 6-mercaptopurine if receiving it for >3 months and if receiving the same dose for at least 8 weeks.
  4. Hemoglobin ≥ 12 g/dL at screening.
  5. Normal white blood cell count and normal lymphocyte count at screening.
  6. Platelet count > lower limit of normal at screening.
  7. For females of childbearing potential, negative serum pregnancy test during the screening period, not breastfeeding for study duration, and willingness to use accepted forms of reliable birth control for study duration [including bilateral tubal ligation, use of oral contraceptives, double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera®, hormonal implants, partner vasectomy, and total abstinence]. Pregnancy tests are not required (indicate "N/A") for males or females not of childbearing potential (post-menopausal with last menstrual period >1 year ago or total hysterectomy).
  8. Patient must have the ability to provide informed consent.

Exclusion Criteria:

  1. Patient with ulcerative colitis, indeterminate colitis, or ulcerative proctitis.
  2. Bowel surgery in past 6 months.
  3. Resection of more than 50 cm of the ileum.
  4. Ileostomy colostomy.
  5. Septic complications.
  6. Patient who is hospitalized or exhibiting signs of toxicity (sepsis), has significant or multiple strictures, or impending obstruction (as evidenced by abdominal distension, severe abdominal tenderness, fever, nausea, vomiting, or tachycardia) or anticipating a need for blood transfusion for gastrointestinal bleeding or in whom surgical intervention may be imminent.
  7. Patient with gastrointestinal abscess, perforation, active draining fistulae or fistulae that are considered clinically significant or perianal lesions.
  8. Patient with history of colorectal cancer or colorectal dysplasia.
  9. Parenteral or tube feeding.
  10. Patient with evidence of infectious colitis, e.g., Clostridium difficile, Amoebiasis, Giardia lamblia or stools positive for other enteric pathogens, ova or parasites at Screening.
  11. Female patient who is pregnant or breastfeeding or wishing to become pregnant during study participation or unwilling to use birth control.
  12. Patient with serum creatinine ≥ 2.0 mg/dL; blood urea nitrogen >40 mg/dL; alkaline phosphatase > 250 U/L; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 100 U/L; or total bilirubin >1.5 mg/dL.
  13. Patient with white blood count <5,000 or >15,000/mm3; platelet count <150,000 per μl; or iron or vitamin B12 deficiency. Correction of lab exclusion is allowed provided that medical condition is not deemed to put patient at risk and stability of result is sustained for a minimum of 30 days.
  14. Patient with active hepatitis B virus, hepatitis C virus, liver cirrhosis or portal hypertension, cytomegalovirus, Epstein Barr Virus or herpes simplex virus or is known to be human immunodeficiency virus (HIV) positive.
  15. Patient with primary sclerosing cholangitis.
  16. Patient with active malignancy or treatment with anticancer drugs in the past 5 years.
  17. Patient received cyclosporine, anti-TNF or other immunomodulatory agents other than azathioprine/6-mercaptopurine 12 weeks prior to Screening.
  18. Patient received methotrexate 4 weeks prior to Screening.
  19. Patient received metronidazole 2 weeks prior to Screening.
  20. Patient received non-steroidal anti-inflammatory drugs (NSAIDS) within 2 weeks before Baseline visit for more than 3 consecutive days, except acetylsalicylic acid ≤ 350 mg/d which is allowed.
  21. Patient received antibiotic, antifungal or antiparasitic medication in the last 2 weeks prior to Screening and/or would potentially require this during the study treatment period.
  22. Patient with history of drug or alcohol abuse within 6 months prior to Screening.
  23. Patient with evidence of poor compliance with medical advice and instruction including diet or medication.
  24. Patient is unable or unwilling to swallow study medication suspension.
  25. Patient with a significant medical condition which puts the patient at risk for study participation and/or for any reason is considered by the Investigator to be an unsuitable candidate to receive CNDO-201 TSO or is potentially put at risk by study procedures.
  26. Patients who has participated in another clinical trial within 30 days of Screening for this trial and/or any experimental treatment for this population.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01434693
Other Study ID Numbers  ICMJE CNDO 201-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Coronado Biosciences, Inc.
Study Sponsor  ICMJE Coronado Biosciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Coronado Biosciences, Inc.
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP