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

This study has been completed.

Study NCT00200343 Information provided by Mitsubishi Tanabe Pharma Corporation

First Received on September 12, 2005. Last Updated on September 29, 2011 History of Changes

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
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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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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

Baseline Measures

	150mg / Day	600mg / Day	900mg / Day	Total
Number of Participants [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
Gender [units: participants]
Female	98	81	70	249
Male	97	117	123	337

[1]	10 patients were excluded from analysis population due to luck of sufficient data.

Outcome Measures

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1. Primary:

Alanine Aminotransferase at Baseline [ Time Frame: 0 week ]

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2. Primary:

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

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3. Secondary:

Aspartate Aminotransferase at Baseline [ Time Frame: 0 week ]

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No text entered.

Limitations and Caveats

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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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

No publications provided

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:	September 29, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare