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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
Enrollment 596

Recruitment Details  
Pre-assignment Details  
Arm/Group Title 150mg / Day 600mg / Day 900mg / Day
Hide Arm/Group Description ursodeoxycholic acid, 150mg/day, three times a day at meals ursodeoxycholic acid, 600mg/day, three times a day at meals ursodeoxycholic acid, 900mg/day, three times a day at meals
Period Title: Overall Study
Started 199 200 197
Completed 183 192 184
Not Completed 16 8 13
Arm/Group Title 150mg / Day 600mg / Day 900mg / Day Total
Hide Arm/Group Description ursodeoxycholic acid, 150mg/day, three times a day at meals ursodeoxycholic acid, 600mg/day, three times a day at meals ursodeoxycholic acid, 900mg/day, three times a day at meals Total of all reporting groups
Overall Number of Baseline Participants 195 198 193 586
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 195 participants 198 participants 193 participants 586 participants
58.0  (12.2) 57.7  (12.0) 59.8  (10.1) 58.4  (11.5)
[1]
Measure Description: 10 patients were excluded from analysis population due to luck of sufficient data.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 195 participants 198 participants 193 participants 586 participants
Female
98
  50.3%
81
  40.9%
70
  36.3%
249
  42.5%
Male
97
  49.7%
117
  59.1%
123
  63.7%
337
  57.5%
1.Primary Outcome
Title Alanine Aminotransferase at Baseline
Hide Description [Not Specified]
Time Frame 0 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
10 patients were excluded from analysis population due to luck of sufficient data.
Arm/Group Title 150mg / Day 600mg / Day 900mg / Day
Hide Arm/Group Description:
ursodeoxycholic acid, 150mg/day, three times a day at meals
ursodeoxycholic acid, 600mg/day, three times a day at meals
ursodeoxycholic acid, 900mg/day, three times a day at meals
Overall Number of Participants Analyzed 195 198 193
Mean (Standard Deviation)
Unit of Measure: IU/L
109.2  (49.7) 106.3  (59.4) 110.6  (57.3)
2.Primary Outcome
Title Percentage Change of Alanine Aminotransferase From Baseline at Week 24
Hide Description Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100
Time Frame 24 weeks (from baseline to Week 24)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100
Arm/Group Title 150mg / Day 600mg / Day 900mg / Day
Hide Arm/Group Description:
ursodeoxycholic acid, 150mg/day, three times a day at meals
ursodeoxycholic acid, 600mg/day, three times a day at meals
ursodeoxycholic acid, 900mg/day, three times a day at meals
Overall Number of Participants Analyzed 195 198 193
Median (Full Range)
Unit of Measure: Percentage of change
-15.3
(-80.7 to 375.9)
-29.2
(-88.3 to 95.2)
-36.2
(-81.4 to 1696.9)
3.Secondary Outcome
Title Aspartate Aminotransferase at Baseline
Hide Description [Not Specified]
Time Frame 0 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 150mg / Day 600mg / Day 900mg / Day
Hide Arm/Group Description:
ursodeoxycholic acid, 150mg/day, three times a day at meals
ursodeoxycholic acid, 600mg/day, three times a day at meals
ursodeoxycholic acid, 900mg/day, three times a day at meals
Overall Number of Participants Analyzed 195 198 193
Mean (Standard Deviation)
Unit of Measure: IU/L
84.0  (39.1) 82.4  (41.8) 85.2  (45.0)
4.Secondary Outcome
Title Percentage Change of Aspartate Aminotransferase From Baseline at Week 24
Hide Description Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100
Time Frame 24 weeks (from baseline to Week 24)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 150mg / Day 600mg / Day 900mg / Day
Hide Arm/Group Description:
ursodeoxycholic acid, 150mg/day, three times a day at meals
ursodeoxycholic acid, 600mg/day, three times a day at meals
ursodeoxycholic acid, 900mg/day, three times a day at meals
Overall Number of Participants Analyzed 195 197 192
Median (Full Range)
Unit of Measure: Percentage of change
-13.6
(-74.2 to 347.2)
-25.0
(-82.7 to 72.5)
-29.8
(-79.0 to 1026.1)
5.Secondary Outcome
Title Gamma-glutamyl Transpeptidase at Baseline
Hide Description [Not Specified]
Time Frame 0 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 150mg / Day 600mg / Day 900mg / Day
Hide Arm/Group Description:
ursodeoxycholic acid, 150mg/day, three times a day at meals
ursodeoxycholic acid, 600mg/day, three times a day at meals
ursodeoxycholic acid, 900mg/day, three times a day at meals
Overall Number of Participants Analyzed 195 198 193
Mean (Standard Deviation)
Unit of Measure: IU/L
87.5  (73.0) 82.4  (62.2) 85.9  (66.3)
6.Secondary Outcome
Title Percentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24
Hide Description Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100
Time Frame 24 weeks (from baseline to Week 24)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100
Arm/Group Title 150mg / Day 600mg / Day 900mg / Day
Hide Arm/Group Description:
ursodeoxycholic acid, 150mg/day, three times a day at meals
ursodeoxycholic acid, 600mg/day, three times a day at meals
ursodeoxycholic acid, 900mg/day, three times a day at meals
Overall Number of Participants Analyzed 195 198 193
Median (Full Range)
Unit of Measure: Percentage of change
-22.4
(-74.6 to 145.9)
-41.0
(-81.1 to 153.1)
-50.0
(-80.1 to 213.9)
Time Frame The reported adverse event data were collected for 24 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 150mg / Day 600mg / Day 900mg / Day
Hide Arm/Group Description ursodeoxycholic acid, 150mg/day, three times a day at meals ursodeoxycholic acid, 600mg/day, three times a day at meals ursodeoxycholic acid, 900mg/day, three times a day at meals
All-Cause Mortality
150mg / Day 600mg / Day 900mg / Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
150mg / Day 600mg / Day 900mg / Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/199 (4.52%)   8/200 (4.00%)   9/197 (4.57%) 
Gastrointestinal disorders       
Colonic polyp  2/199 (1.01%)  0/200 (0.00%)  1/197 (0.51%) 
Diverticulum intestinal haemorrhagic  0/199 (0.00%)  0/200 (0.00%)  1/197 (0.51%) 
Oesophageal varices haemorrhage  0/199 (0.00%)  1/200 (0.50%)  0/197 (0.00%) 
Appendicitis perforated  1/199 (0.50%)  0/200 (0.00%)  0/197 (0.00%) 
Enterocolitis  0/199 (0.00%)  0/200 (0.00%)  1/197 (0.51%) 
Pancreatitis chronic  0/199 (0.00%)  1/200 (0.50%)  0/197 (0.00%) 
Inguinal hernia NOS  0/199 (0.00%)  0/200 (0.00%)  1/197 (0.51%) 
General disorders       
Pyrexia  1/199 (0.50%)  0/200 (0.00%)  0/197 (0.00%) 
Hepatobiliary disorders       
Hepatic cirrhosis NOS  0/199 (0.00%)  1/200 (0.50%)  1/197 (0.51%) 
Infections and infestations       
Cellulitis  1/199 (0.50%)  0/200 (0.00%)  0/197 (0.00%) 
Nasopharyngitis  0/199 (0.00%)  1/200 (0.50%)  0/197 (0.00%) 
Injury, poisoning and procedural complications       
Sternal fracture  1/199 (0.50%)  0/200 (0.00%)  0/197 (0.00%) 
Metabolism and nutrition disorders       
Anorexia  1/199 (0.50%)  0/200 (0.00%)  0/197 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Hepatic neoplasm malignant NOS  2/199 (1.01%)  2/200 (1.00%)  1/197 (0.51%) 
Renal neoplasm NOS  0/199 (0.00%)  0/200 (0.00%)  1/197 (0.51%) 
Lung cancer stage unspecified (excl metastatic tumours to lung)  1/199 (0.50%)  0/200 (0.00%)  0/197 (0.00%) 
Nervous system disorders       
Subarachnoid haemorrhage NOS  0/199 (0.00%)  0/200 (0.00%)  1/197 (0.51%) 
Cerebral infarction  0/199 (0.00%)  1/200 (0.50%)  0/197 (0.00%) 
Lumbar spinal stenosis  0/199 (0.00%)  0/200 (0.00%)  1/197 (0.51%) 
Renal and urinary disorders       
Calculus ureteric  1/199 (0.50%)  1/200 (0.50%)  0/197 (0.00%) 
1
Term from vocabulary, MedDRA ver.6.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
150mg / Day 600mg / Day 900mg / Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   130/199 (65.33%)   122/200 (61.00%)   119/197 (60.41%) 
Gastrointestinal disorders       
Abdominal distention  3/199 (1.51%)  4/200 (2.00%)  3/197 (1.52%) 
Abdominal pain NOS  4/199 (2.01%)  3/200 (1.50%)  2/197 (1.02%) 
Abdominal pain upper  3/199 (1.51%)  5/200 (2.50%)  6/197 (3.05%) 
Constipation  4/199 (2.01%)  4/200 (2.00%)  6/197 (3.05%) 
Diarrhoea NOS  9/199 (4.52%)  12/200 (6.00%)  15/197 (7.61%) 
Dyspepsia  3/199 (1.51%)  2/200 (1.00%)  3/197 (1.52%) 
Loose stools  1/199 (0.50%)  6/200 (3.00%)  5/197 (2.54%) 
Nausea  3/199 (1.51%)  2/200 (1.00%)  3/197 (1.52%) 
Stomach discomfort  3/199 (1.51%)  3/200 (1.50%)  6/197 (3.05%) 
Stomatitis  1/199 (0.50%)  1/200 (0.50%)  7/197 (3.55%) 
General disorders       
Chest discomfort  5/199 (2.51%)  1/200 (0.50%)  0/197 (0.00%) 
Malaise  2/199 (1.01%)  5/200 (2.50%)  2/197 (1.02%) 
Oedema peripheral  1/199 (0.50%)  2/200 (1.00%)  3/197 (1.52%) 
Infections and infestations       
Nasopharyngitis  51/199 (25.63%)  49/200 (24.50%)  52/197 (26.40%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  5/199 (2.51%)  2/200 (1.00%)  2/197 (1.02%) 
Back pain  5/199 (2.51%)  6/200 (3.00%)  5/197 (2.54%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Hepatic neoplasm malignant NOS  0/199 (0.00%)  1/200 (0.50%)  1/197 (0.51%) 
Nervous system disorders       
Dizziness  6/199 (3.02%)  1/200 (0.50%)  3/197 (1.52%) 
Headache  6/199 (3.02%)  6/200 (3.00%)  6/197 (3.05%) 
Psychiatric disorders       
Insomnia  4/199 (2.01%)  2/200 (1.00%)  2/197 (1.02%) 
Renal and urinary disorders       
Cystitis NOS  6/199 (3.02%)  0/200 (0.00%)  4/197 (2.03%) 
Respiratory, thoracic and mediastinal disorders       
Epistaxis  2/199 (1.01%)  3/200 (1.50%)  1/197 (0.51%) 
Pharyngolaryngeal pain  2/199 (1.01%)  3/200 (1.50%)  1/197 (0.51%) 
Upper respiratory tract inflammation  3/199 (1.51%)  4/200 (2.00%)  4/197 (2.03%) 
Skin and subcutaneous tissue disorders       
Eczema  2/199 (1.01%)  2/200 (1.00%)  3/197 (1.52%) 
Pruritus  6/199 (3.02%)  3/200 (1.50%)  4/197 (2.03%) 
Rash NOS  2/199 (1.01%)  5/200 (2.50%)  1/197 (0.51%) 
1
Term from vocabulary, MedDRA ver.6.0
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.
 
Results Point of Contact
Name/Title: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
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