Pentoxifylline for Primary Biliary Cirrhosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claudia Zein, MD, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01249092
First received: November 24, 2010
Last updated: October 16, 2013
Last verified: October 2013
Results First Received: July 31, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Primary Biliary Cirrhosis
Intervention: Drug: Pentoxifylline

  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
Patient enrollment was initiated in December 2010 and a total of 20 patients were enrolled. The last patient to complete the pilot study completed participation in June 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was a single arm open label pilot study where all subjects received the same intervention throughout the study duration. There were no different study groups and no randomization was involved.

Reporting Groups
  Description
Pentoxifylline 400 mg/d All patients received same intervention.

Participant Flow:   Overall Study
    Pentoxifylline 400 mg/d  
STARTED     20  
COMPLETED     18  
NOT COMPLETED     2  
Expected side effect of nausea/dyspepsia                 1  
Unable to tolerate expected SE -nausea                 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
Pentoxifylline 400 mg/d All patients received same intervention.

Baseline Measures
    Pentoxifylline 400 mg/d  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     6  
>=65 years     14  
Age  
[units: years]
Mean ± Standard Deviation
  57.7  ± 9.6  
Gender  
[units: participants]
 
Female     18  
Male     2  
Region of Enrollment  
[units: participants]
 
United States     20  



  Outcome Measures
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1.  Primary:   Change in Serum Alkaline Phosphatase Levels.   [ Time Frame: 6 months ]

2.  Secondary:   Change in Serum Concentration of Tissue Inhibitor Metalloproteinase 1 (TIMP-1) After PTX Therapy.   [ Time Frame: 6 months ]

3.  Secondary:   Safety of Therapy in the Pilot Study of PTX Therapy in Patients With PBC Will be Assessed   [ Time Frame: 6 months ]


  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
Our study was a small open label pilot completed with no technical problems. The information generated will be useful in designing future larger studies. The main limitation is that PBC is a rare disease which resulted in prolonged enrollment phase.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Claudia O. Zein, MD
Organization: Cleveland Clinic
phone: 216-444-0421
e-mail: zeinc@ccf.org


No publications provided


Responsible Party: Claudia Zein, MD, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01249092     History of Changes
Other Study ID Numbers: 07-1003
Study First Received: November 24, 2010
Results First Received: July 31, 2013
Last Updated: October 16, 2013
Health Authority: United States: Food and Drug Administration