Trial Outcomes & Findings for Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C (NCT NCT00200343)

NCT ID: NCT00200343

Last Updated: 2026-01-07

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

596 participants

Primary outcome timeframe

0 week

Results posted on

2026-01-07

Participant Flow

Participant milestones

Participant milestones
Measure	600mg / Day ursodeoxycholic acid, 600mg/day, three times a day at meals	900mg / Day ursodeoxycholic acid, 900mg/day, three times a day at meals	150mg / Day ursodeoxycholic acid, 150mg/day, three times a day at meals
Overall Study STARTED	200	197	199
Overall Study COMPLETED	192	184	183
Overall Study NOT COMPLETED	8	13	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	150mg / Day n=195 Participants ursodeoxycholic acid, 150mg/day, three times a day at meals	600mg / Day n=198 Participants ursodeoxycholic acid, 600mg/day, three times a day at meals	900mg / Day n=193 Participants ursodeoxycholic acid, 900mg/day, three times a day at meals	Total n=586 Participants Total of all reporting groups
Age, Continuous	58.0 years STANDARD_DEVIATION 12.2 • n=9 Participants	57.7 years STANDARD_DEVIATION 12.0 • n=6 Participants	59.8 years STANDARD_DEVIATION 10.1 • n=9 Participants	58.4 years STANDARD_DEVIATION 11.5 • n=17 Participants
Sex: Female, Male Female	98 Participants n=9 Participants	81 Participants n=6 Participants	70 Participants n=9 Participants	249 Participants n=17 Participants
Sex: Female, Male Male	97 Participants n=9 Participants	117 Participants n=6 Participants	123 Participants n=9 Participants	337 Participants n=17 Participants

PRIMARY outcome

Timeframe: 0 week

Population: 10 patients were excluded from analysis population due to luck of sufficient data.

Outcome measures

Outcome measures
Measure	150mg / Day n=195 Participants ursodeoxycholic acid, 150mg/day, three times a day at meals	600mg / Day n=198 Participants ursodeoxycholic acid, 600mg/day, three times a day at meals	900mg / Day n=193 Participants ursodeoxycholic acid, 900mg/day, three times a day at meals
Alanine Aminotransferase at Baseline	109.2 IU/L Standard Deviation 49.7	106.3 IU/L Standard Deviation 59.4	110.6 IU/L Standard Deviation 57.3

PRIMARY outcome

Timeframe: 24 weeks (from baseline to Week 24)

Population: percentage change=\[(measured value at Week 24 - measured value at baseline)/measured value at baseline\]\*100

Percentage change=\[(measured value at Week 24 - measured value at baseline)/measured value at baseline\]\*100

Outcome measures

Outcome measures
Measure	150mg / Day n=195 Participants ursodeoxycholic acid, 150mg/day, three times a day at meals	600mg / Day n=198 Participants ursodeoxycholic acid, 600mg/day, three times a day at meals	900mg / Day n=193 Participants ursodeoxycholic acid, 900mg/day, three times a day at meals
Percentage Change of Alanine Aminotransferase From Baseline at Week 24	-15.3 Percentage of change Interval -80.7 to 375.9	-29.2 Percentage of change Interval -88.3 to 95.2	-36.2 Percentage of change Interval -81.4 to 1696.9

SECONDARY outcome

Timeframe: 0 week

Outcome measures

Outcome measures
Measure	150mg / Day n=195 Participants ursodeoxycholic acid, 150mg/day, three times a day at meals	600mg / Day n=198 Participants ursodeoxycholic acid, 600mg/day, three times a day at meals	900mg / Day n=193 Participants ursodeoxycholic acid, 900mg/day, three times a day at meals
Aspartate Aminotransferase at Baseline	84.0 IU/L Standard Deviation 39.1	82.4 IU/L Standard Deviation 41.8	85.2 IU/L Standard Deviation 45.0

SECONDARY outcome

Timeframe: 24 weeks (from baseline to Week 24)

Percentage change=\[(measured value at Week 24 - measured value at baseline)/measured value at baseline\]\*100

Outcome measures

Outcome measures
Measure	150mg / Day n=195 Participants ursodeoxycholic acid, 150mg/day, three times a day at meals	600mg / Day n=197 Participants ursodeoxycholic acid, 600mg/day, three times a day at meals	900mg / Day n=192 Participants ursodeoxycholic acid, 900mg/day, three times a day at meals
Percentage Change of Aspartate Aminotransferase From Baseline at Week 24	-13.6 Percentage of change Interval -74.2 to 347.2	-25.0 Percentage of change Interval -82.7 to 72.5	-29.8 Percentage of change Interval -79.0 to 1026.1

SECONDARY outcome

Timeframe: 0 week

Outcome measures

Outcome measures
Measure	150mg / Day n=195 Participants ursodeoxycholic acid, 150mg/day, three times a day at meals	600mg / Day n=198 Participants ursodeoxycholic acid, 600mg/day, three times a day at meals	900mg / Day n=193 Participants ursodeoxycholic acid, 900mg/day, three times a day at meals
Gamma-glutamyl Transpeptidase at Baseline	87.5 IU/L Standard Deviation 73.0	82.4 IU/L Standard Deviation 62.2	85.9 IU/L Standard Deviation 66.3

SECONDARY outcome

Timeframe: 24 weeks (from baseline to Week 24)

Population: percentage change=\[(measured value at Week 24 - measured value at baseline)/measured value at baseline\]\*100

Percentage change=\[(measured value at Week 24 - measured value at baseline)/measured value at baseline\]\*100

Outcome measures

Outcome measures
Measure	150mg / Day n=195 Participants ursodeoxycholic acid, 150mg/day, three times a day at meals	600mg / Day n=198 Participants ursodeoxycholic acid, 600mg/day, three times a day at meals	900mg / Day n=193 Participants ursodeoxycholic acid, 900mg/day, three times a day at meals
Percentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24	-22.4 Percentage of change Interval -74.6 to 145.9	-41.0 Percentage of change Interval -81.1 to 153.1	-50.0 Percentage of change Interval -80.1 to 213.9

Adverse Events

150mg / Day

Serious events: 9 serious events

Other events: 130 other events

Deaths: 0 deaths

600mg / Day

Serious events: 8 serious events

Other events: 122 other events

Deaths: 0 deaths

900mg / Day

Serious events: 9 serious events

Other events: 119 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Trials, Information Desk

Tanabe Pharma Corporation

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	150mg / Day n=199 participants at risk ursodeoxycholic acid, 150mg/day, three times a day at meals	600mg / Day n=200 participants at risk ursodeoxycholic acid, 600mg/day, three times a day at meals	900mg / Day n=197 participants at risk ursodeoxycholic acid, 900mg/day, three times a day at meals
Gastrointestinal disorders Colonic polyp	1.0% 2/199 • The reported adverse event data were collected for 24 weeks.	0.00% 0/200 • The reported adverse event data were collected for 24 weeks.	0.51% 1/197 • The reported adverse event data were collected for 24 weeks.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.00% 0/199 • The reported adverse event data were collected for 24 weeks.	0.00% 0/200 • The reported adverse event data were collected for 24 weeks.	0.51% 1/197 • The reported adverse event data were collected for 24 weeks.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/199 • The reported adverse event data were collected for 24 weeks.	0.50% 1/200 • The reported adverse event data were collected for 24 weeks.	0.00% 0/197 • The reported adverse event data were collected for 24 weeks.
Gastrointestinal disorders Appendicitis perforated	0.50% 1/199 • The reported adverse event data were collected for 24 weeks.	0.00% 0/200 • The reported adverse event data were collected for 24 weeks.	0.00% 0/197 • The reported adverse event data were collected for 24 weeks.
Gastrointestinal disorders Enterocolitis	0.00% 0/199 • The reported adverse event data were collected for 24 weeks.	0.00% 0/200 • The reported adverse event data were collected for 24 weeks.	0.51% 1/197 • The reported adverse event data were collected for 24 weeks.
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/199 • The reported adverse event data were collected for 24 weeks.	0.50% 1/200 • The reported adverse event data were collected for 24 weeks.	0.00% 0/197 • The reported adverse event data were collected for 24 weeks.
Gastrointestinal disorders Inguinal hernia NOS	0.00% 0/199 • The reported adverse event data were collected for 24 weeks.	0.00% 0/200 • The reported adverse event data were collected for 24 weeks.	0.51% 1/197 • The reported adverse event data were collected for 24 weeks.
General disorders Pyrexia	0.50% 1/199 • The reported adverse event data were collected for 24 weeks.	0.00% 0/200 • The reported adverse event data were collected for 24 weeks.	0.00% 0/197 • The reported adverse event data were collected for 24 weeks.
Hepatobiliary disorders Hepatic cirrhosis NOS	0.00% 0/199 • The reported adverse event data were collected for 24 weeks.	0.50% 1/200 • The reported adverse event data were collected for 24 weeks.	0.51% 1/197 • The reported adverse event data were collected for 24 weeks.
Infections and infestations Cellulitis	0.50% 1/199 • The reported adverse event data were collected for 24 weeks.	0.00% 0/200 • The reported adverse event data were collected for 24 weeks.	0.00% 0/197 • The reported adverse event data were collected for 24 weeks.
Infections and infestations Nasopharyngitis	0.00% 0/199 • The reported adverse event data were collected for 24 weeks.	0.50% 1/200 • The reported adverse event data were collected for 24 weeks.	0.00% 0/197 • The reported adverse event data were collected for 24 weeks.
Injury, poisoning and procedural complications Sternal fracture	0.50% 1/199 • The reported adverse event data were collected for 24 weeks.	0.00% 0/200 • The reported adverse event data were collected for 24 weeks.	0.00% 0/197 • The reported adverse event data were collected for 24 weeks.
Metabolism and nutrition disorders Anorexia	0.50% 1/199 • The reported adverse event data were collected for 24 weeks.	0.00% 0/200 • The reported adverse event data were collected for 24 weeks.	0.00% 0/197 • The reported adverse event data were collected for 24 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant NOS	1.0% 2/199 • The reported adverse event data were collected for 24 weeks.	1.0% 2/200 • The reported adverse event data were collected for 24 weeks.	0.51% 1/197 • The reported adverse event data were collected for 24 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm NOS	0.00% 0/199 • The reported adverse event data were collected for 24 weeks.	0.00% 0/200 • The reported adverse event data were collected for 24 weeks.	0.51% 1/197 • The reported adverse event data were collected for 24 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer stage unspecified (excl metastatic tumours to lung)	0.50% 1/199 • The reported adverse event data were collected for 24 weeks.	0.00% 0/200 • The reported adverse event data were collected for 24 weeks.	0.00% 0/197 • The reported adverse event data were collected for 24 weeks.
Nervous system disorders Subarachnoid haemorrhage NOS	0.00% 0/199 • The reported adverse event data were collected for 24 weeks.	0.00% 0/200 • The reported adverse event data were collected for 24 weeks.	0.51% 1/197 • The reported adverse event data were collected for 24 weeks.
Nervous system disorders Cerebral infarction	0.00% 0/199 • The reported adverse event data were collected for 24 weeks.	0.50% 1/200 • The reported adverse event data were collected for 24 weeks.	0.00% 0/197 • The reported adverse event data were collected for 24 weeks.
Nervous system disorders Lumbar spinal stenosis	0.00% 0/199 • The reported adverse event data were collected for 24 weeks.	0.00% 0/200 • The reported adverse event data were collected for 24 weeks.	0.51% 1/197 • The reported adverse event data were collected for 24 weeks.
Renal and urinary disorders Calculus ureteric	0.50% 1/199 • The reported adverse event data were collected for 24 weeks.	0.50% 1/200 • The reported adverse event data were collected for 24 weeks.	0.00% 0/197 • The reported adverse event data were collected for 24 weeks.

Measure	150mg / Day n=199 participants at risk ursodeoxycholic acid, 150mg/day, three times a day at meals	600mg / Day n=200 participants at risk ursodeoxycholic acid, 600mg/day, three times a day at meals	900mg / Day n=197 participants at risk ursodeoxycholic acid, 900mg/day, three times a day at meals
General disorders Oedema peripheral	0.50% 1/199 • The reported adverse event data were collected for 24 weeks.	1.0% 2/200 • The reported adverse event data were collected for 24 weeks.	1.5% 3/197 • The reported adverse event data were collected for 24 weeks.
Infections and infestations Nasopharyngitis	25.6% 51/199 • The reported adverse event data were collected for 24 weeks.	24.5% 49/200 • The reported adverse event data were collected for 24 weeks.	26.4% 52/197 • The reported adverse event data were collected for 24 weeks.
Musculoskeletal and connective tissue disorders Arthralgia	2.5% 5/199 • The reported adverse event data were collected for 24 weeks.	1.0% 2/200 • The reported adverse event data were collected for 24 weeks.	1.0% 2/197 • The reported adverse event data were collected for 24 weeks.
Musculoskeletal and connective tissue disorders Back pain	2.5% 5/199 • The reported adverse event data were collected for 24 weeks.	3.0% 6/200 • The reported adverse event data were collected for 24 weeks.	2.5% 5/197 • The reported adverse event data were collected for 24 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant NOS	0.00% 0/199 • The reported adverse event data were collected for 24 weeks.	0.50% 1/200 • The reported adverse event data were collected for 24 weeks.	0.51% 1/197 • The reported adverse event data were collected for 24 weeks.
Nervous system disorders Dizziness	3.0% 6/199 • The reported adverse event data were collected for 24 weeks.	0.50% 1/200 • The reported adverse event data were collected for 24 weeks.	1.5% 3/197 • The reported adverse event data were collected for 24 weeks.
Nervous system disorders Headache	3.0% 6/199 • The reported adverse event data were collected for 24 weeks.	3.0% 6/200 • The reported adverse event data were collected for 24 weeks.	3.0% 6/197 • The reported adverse event data were collected for 24 weeks.
Psychiatric disorders Insomnia	2.0% 4/199 • The reported adverse event data were collected for 24 weeks.	1.0% 2/200 • The reported adverse event data were collected for 24 weeks.	1.0% 2/197 • The reported adverse event data were collected for 24 weeks.
Renal and urinary disorders Cystitis NOS	3.0% 6/199 • The reported adverse event data were collected for 24 weeks.	0.00% 0/200 • The reported adverse event data were collected for 24 weeks.	2.0% 4/197 • The reported adverse event data were collected for 24 weeks.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.0% 2/199 • The reported adverse event data were collected for 24 weeks.	1.5% 3/200 • The reported adverse event data were collected for 24 weeks.	0.51% 1/197 • The reported adverse event data were collected for 24 weeks.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	1.0% 2/199 • The reported adverse event data were collected for 24 weeks.	1.5% 3/200 • The reported adverse event data were collected for 24 weeks.	0.51% 1/197 • The reported adverse event data were collected for 24 weeks.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	1.5% 3/199 • The reported adverse event data were collected for 24 weeks.	2.0% 4/200 • The reported adverse event data were collected for 24 weeks.	2.0% 4/197 • The reported adverse event data were collected for 24 weeks.
Skin and subcutaneous tissue disorders Eczema	1.0% 2/199 • The reported adverse event data were collected for 24 weeks.	1.0% 2/200 • The reported adverse event data were collected for 24 weeks.	1.5% 3/197 • The reported adverse event data were collected for 24 weeks.
Skin and subcutaneous tissue disorders Pruritus	3.0% 6/199 • The reported adverse event data were collected for 24 weeks.	1.5% 3/200 • The reported adverse event data were collected for 24 weeks.	2.0% 4/197 • The reported adverse event data were collected for 24 weeks.
Skin and subcutaneous tissue disorders Rash NOS	1.0% 2/199 • The reported adverse event data were collected for 24 weeks.	2.5% 5/200 • The reported adverse event data were collected for 24 weeks.	0.51% 1/197 • The reported adverse event data were collected for 24 weeks.
Gastrointestinal disorders Abdominal distention	1.5% 3/199 • The reported adverse event data were collected for 24 weeks.	2.0% 4/200 • The reported adverse event data were collected for 24 weeks.	1.5% 3/197 • The reported adverse event data were collected for 24 weeks.
Gastrointestinal disorders Abdominal pain NOS	2.0% 4/199 • The reported adverse event data were collected for 24 weeks.	1.5% 3/200 • The reported adverse event data were collected for 24 weeks.	1.0% 2/197 • The reported adverse event data were collected for 24 weeks.
Gastrointestinal disorders Abdominal pain upper	1.5% 3/199 • The reported adverse event data were collected for 24 weeks.	2.5% 5/200 • The reported adverse event data were collected for 24 weeks.	3.0% 6/197 • The reported adverse event data were collected for 24 weeks.
Gastrointestinal disorders Constipation	2.0% 4/199 • The reported adverse event data were collected for 24 weeks.	2.0% 4/200 • The reported adverse event data were collected for 24 weeks.	3.0% 6/197 • The reported adverse event data were collected for 24 weeks.
Gastrointestinal disorders Diarrhoea NOS	4.5% 9/199 • The reported adverse event data were collected for 24 weeks.	6.0% 12/200 • The reported adverse event data were collected for 24 weeks.	7.6% 15/197 • The reported adverse event data were collected for 24 weeks.
Gastrointestinal disorders Dyspepsia	1.5% 3/199 • The reported adverse event data were collected for 24 weeks.	1.0% 2/200 • The reported adverse event data were collected for 24 weeks.	1.5% 3/197 • The reported adverse event data were collected for 24 weeks.
Gastrointestinal disorders Loose stools	0.50% 1/199 • The reported adverse event data were collected for 24 weeks.	3.0% 6/200 • The reported adverse event data were collected for 24 weeks.	2.5% 5/197 • The reported adverse event data were collected for 24 weeks.
Gastrointestinal disorders Nausea	1.5% 3/199 • The reported adverse event data were collected for 24 weeks.	1.0% 2/200 • The reported adverse event data were collected for 24 weeks.	1.5% 3/197 • The reported adverse event data were collected for 24 weeks.
Gastrointestinal disorders Stomach discomfort	1.5% 3/199 • The reported adverse event data were collected for 24 weeks.	1.5% 3/200 • The reported adverse event data were collected for 24 weeks.	3.0% 6/197 • The reported adverse event data were collected for 24 weeks.
Gastrointestinal disorders Stomatitis	0.50% 1/199 • The reported adverse event data were collected for 24 weeks.	0.50% 1/200 • The reported adverse event data were collected for 24 weeks.	3.6% 7/197 • The reported adverse event data were collected for 24 weeks.
General disorders Chest discomfort	2.5% 5/199 • The reported adverse event data were collected for 24 weeks.	0.50% 1/200 • The reported adverse event data were collected for 24 weeks.	0.00% 0/197 • The reported adverse event data were collected for 24 weeks.
General disorders Malaise	1.0% 2/199 • The reported adverse event data were collected for 24 weeks.	2.5% 5/200 • The reported adverse event data were collected for 24 weeks.	1.0% 2/197 • The reported adverse event data were collected for 24 weeks.