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Efficacy and Safety of Trichuris Suis Ova (TSO) as Compared to Placebo (TRUST-I)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coronado Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01576471
First received: April 10, 2012
Last updated: May 30, 2017
Last verified: April 2017
Results First Received: April 3, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Crohn's Disease
Interventions: Biological: Trichuris suis ova (TSO)
Biological: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Placebo: Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)
TSO 7500 Trichuris suis ova (TSO): TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)

Participant Flow:   Overall Study
    Placebo   TSO 7500
STARTED   125   125 
COMPLETED   117   116 
NOT COMPLETED   8   9 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Placebo: Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)
TSO 7500 Trichuris suis ova (TSO): TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)
Total Total of all reporting groups

Baseline Measures
   Placebo   TSO 7500   Total 
Overall Participants Analyzed 
[Units: Participants]
 125   125   250 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      125 100.0%      125 100.0%      250 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.6  (1.07)   40.9  (1.04)   39.8  (0.75) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      61  48.8%      71  56.8%      132  52.8% 
Male      64  51.2%      54  43.2%      118  47.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      15  12.0%      13  10.4%      28  11.2% 
Not Hispanic or Latino      110  88.0%      112  89.6%      222  88.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   0.8%      0   0.0%      1   0.4% 
Asian      3   2.4%      1   0.8%      4   1.6% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      7   5.6%      4   3.2%      11   4.4% 
White      112  89.6%      117  93.6%      229  91.6% 
More than one race      2   1.6%      3   2.4%      5   2.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   125   125   250 


  Outcome Measures

1.  Primary:   Evaluate the Effects of TSO on the Induction of Response in Crohn's Disease, as Measured Primarily by Crohn's Disease Activity Index (CDAI)   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Clinical Operations
Organization: Coronado Biosciences
phone: 7816524516
e-mail: nsilver@coronadobio.com



Responsible Party: Coronado Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01576471     History of Changes
Other Study ID Numbers: CNDO 201-003
Study First Received: April 10, 2012
Results First Received: April 3, 2017
Last Updated: May 30, 2017