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Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C

This study has been completed.
Sponsor:
Information provided by:
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00200343
First received: September 12, 2005
Last updated: March 7, 2012
Last verified: March 2012
Results First Received: August 17, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Chronic Hepatitis C
Interventions: Drug: Ursodeoxycholic acid 150mg / day
Drug: Ursodeoxycholic acid 600mg / day
Drug: Ursodeoxycholic acid 900mg / day

  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
150mg / Day ursodeoxycholic acid, 150mg/day, three times a day at meals
600mg / Day ursodeoxycholic acid, 600mg/day, three times a day at meals
900mg / Day ursodeoxycholic acid, 900mg/day, three times a day at meals

Participant Flow:   Overall Study
    150mg / Day   600mg / Day   900mg / Day
STARTED   199   200   197 
COMPLETED   183   192   184 
NOT COMPLETED   16   8   13 



  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
150mg / Day ursodeoxycholic acid, 150mg/day, three times a day at meals
600mg / Day ursodeoxycholic acid, 600mg/day, three times a day at meals
900mg / Day ursodeoxycholic acid, 900mg/day, three times a day at meals
Total Total of all reporting groups

Baseline Measures
   150mg / Day   600mg / Day   900mg / Day   Total 
Overall Participants Analyzed 
[Units: Participants]
 195   198   193   586 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 58.0  (12.2)   57.7  (12.0)   59.8  (10.1)   58.4  (11.5) 
[1] 10 patients were excluded from analysis population due to luck of sufficient data.
Gender 
[Units: Participants]
       
Female   98   81   70   249 
Male   97   117   123   337 


  Outcome Measures
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1.  Primary:   Alanine Aminotransferase at Baseline   [ Time Frame: 0 week ]

2.  Primary:   Percentage Change of Alanine Aminotransferase From Baseline at Week 24   [ Time Frame: 24 weeks (from baseline to Week 24) ]

3.  Secondary:   Aspartate Aminotransferase at Baseline   [ Time Frame: 0 week ]

4.  Secondary:   Percentage Change of Aspartate Aminotransferase From Baseline at Week 24   [ Time Frame: 24 weeks (from baseline to Week 24) ]

5.  Secondary:   Gamma-glutamyl Transpeptidase at Baseline   [ Time Frame: 0 week ]

6.  Secondary:   Percentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24   [ Time Frame: 24 weeks (from baseline to Week 24) ]


  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: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
e-mail: cti-inq-ml@ml.mt-pharma.co.jp


Publications of Results:

ClinicalTrials.gov Identifier: NCT00200343     History of Changes
Other Study ID Numbers: MT711-01
Study First Received: September 12, 2005
Results First Received: August 17, 2011
Last Updated: March 7, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare