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Thalidomide for the Treatment of Primary Sclerosing Cholangitis (PSC)

This study has been terminated.
(Lack of enrollment)
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00953615
First received: August 4, 2009
Last updated: January 24, 2012
Last verified: January 2012
Results First Received: August 8, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Primary Sclerosing Cholangitis
Intervention: Drug: Thalidomide

  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
Participants were recruited between 4/6/2006 and 5/7/2009 at Mayo Clinic outpatient area.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Thalidomide Patients with primary sclerosing cholangitis (PSC) who met with enrollment criteria were treated with 400 mg in the evening for a duration of 6 months

Participant Flow:   Overall Study
    Thalidomide  
STARTED     1  
COMPLETED     0  
NOT COMPLETED     1  
Adverse Event                 1  



  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
Thalidomide Patients with primary sclerosing cholangitis (PSC) who met with enrollment criteria were treated with 400 mg in the evening for a duration of 6 months

Baseline Measures
    Thalidomide  
Number of Participants  
[units: participants]
  1  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     0  
Gender  
[units: participants]
 
Female     0  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase   [ Time Frame: 6 months, baseline ]

2.  Secondary:   Overall Toxicity and Tolerability   [ Time Frame: 6 months ]

3.  Secondary:   Mayo Risk Score   [ Time Frame: 6 months ]

4.  Secondary:   Soluble Tumor Necrosis Factor - Alpha   [ Time Frame: 6 months, baseline ]


  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
Only one subject was enrolled, so study was terminated.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Keith D. Lindor, M.D.
Organization: Mayo Clinic
phone: 507-284-2969
e-mail: lindor.keith@mayo.edu


No publications provided


Responsible Party: Dr. K. Lindor, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00953615     History of Changes
Other Study ID Numbers: 342-06
Study First Received: August 4, 2009
Results First Received: August 8, 2011
Last Updated: January 24, 2012
Health Authority: United States: Food and Drug Administration