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

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ClinicalTrials.gov Identifier: NCT00200343

Recruitment Status : Completed

First Posted : September 20, 2005

Results First Posted : November 7, 2011

Last Update Posted : March 12, 2012

Sponsor:

Information provided by:

Mitsubishi Tanabe Pharma Corporation

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; 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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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.
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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
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

249

Male

117

123

337

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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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:

	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.

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:

Omata M, Yoshida H, Toyota J, Tomita E, Nishiguchi S, Hayashi N, Iino S, Makino I, Okita K, Toda G, Tanikawa K, Kumada H; Japanese C-Viral Hepatitis Network. A large-scale, multicentre, double-blind trial of ursodeoxycholic acid in patients with chronic hepatitis C. Gut. 2007 Dec;56(12):1747-53. Epub 2007 Jun 15.

ClinicalTrials.gov Identifier:	NCT00200343 History of Changes
Other Study ID Numbers:	MT711-01
First Submitted:	September 12, 2005
First Posted:	September 20, 2005
Results First Submitted:	August 17, 2011
Results First Posted:	November 7, 2011
Last Update Posted:	March 12, 2012

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