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Trial record 29 of 92 for:    Primary Sclerosing Cholangitis

Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC) (AESOP)

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ClinicalTrials.gov Identifier: NCT02177136
Recruitment Status : Completed
First Posted : June 27, 2014
Results First Posted : May 30, 2018
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Intercept Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Primary Sclerosing Cholangitis (PSC)
Interventions Drug: OCA
Drug: Placebo
Enrollment 77
Recruitment Details  
Pre-assignment Details A total of 77 patient were randomly allocated to treatment with placebo, 1.5 mg OCA titrated to 3 mg OCA or 5 mg OCA titrated to 10 mg OCA; however, 1 subject did not receive treatment.
Arm/Group Title 1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo
Hide Arm/Group Description

Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.

OCA

Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.

OCA

Subjects randomized to placebo will take placebo daily for 24 weeks.

Placebo

Period Title: Overall Study
Started 25 26 25
Completed 19 21 21
Not Completed 6 5 4
Reason Not Completed
Withdrawal by Subject             2             0             0
Discontinued due to pruritus             1             3             0
Adverse Event             3             2             3
Protocol Violation             0             0             1
Arm/Group Title 1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo Total
Hide Arm/Group Description

Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.

OCA

Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.

OCA

Subjects randomized to placebo will take placebo for 24 weeks.

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 25 26 25 76
Hide Baseline Analysis Population Description
A total of 77 patient were randomly allocated to treatment with placebo, 1.5 mg OCA titrated to 3 mg or 5mg OCA titrated to 10mg; however, 1 subject did not receive treatment. Therefore, the baseline analysis population of 76 subjects is the Intent-to-Treat Population.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 26 participants 25 participants 76 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
24
  96.0%
23
  88.5%
24
  96.0%
71
  93.4%
>=65 years
1
   4.0%
3
  11.5%
1
   4.0%
5
   6.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 26 participants 25 participants 76 participants
41.6  (12.56) 44.9  (14.28) 43.7  (13.05) 43.4  (13.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 26 participants 25 participants 76 participants
Female
10
  40.0%
14
  53.8%
11
  44.0%
35
  46.1%
Male
15
  60.0%
12
  46.2%
14
  56.0%
41
  53.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 26 participants 25 participants 76 participants
Hispanic or Latino
2
   8.0%
2
   7.7%
1
   4.0%
5
   6.6%
Not Hispanic or Latino
23
  92.0%
24
  92.3%
24
  96.0%
71
  93.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 26 participants 25 participants 76 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   4.0%
0
   0.0%
0
   0.0%
1
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  12.0%
4
  15.4%
3
  12.0%
10
  13.2%
White
21
  84.0%
22
  84.6%
22
  88.0%
65
  85.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Alkaline phosphatase (ALP)  
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 25 participants 26 participants 25 participants 76 participants
422.5  (123.07) 428.5  (178.19) 562.8  (300.22) 470.7  (220.20)
Total Bilirubin  
Mean (Standard Deviation)
Unit of measure:  umol/L
Number Analyzed 25 participants 26 participants 25 participants 76 participants
16.3  (8.17) 19.4  (10.94) 20.9  (11.48) 18.9  (10.35)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 25 participants 26 participants 25 participants 76 participants
74.5  (12.51) 73.6  (12.76) 73.0  (12.95) 73.7  (12.59)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 25 participants 26 participants 25 participants 76 participants
174.4  (8.95) 170.4  (11.61) 172.6  (10.70) 172.4  (10.49)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 25 participants 26 participants 25 participants 76 participants
24.6  (4.38) 25.3  (3.74) 24.5  (3.71) 24.8  (3.92)
International Normalized Ratio (INR)   [1] 
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 25 participants 26 participants 25 participants 76 participants
1.0  (0.06) 1.0  (0.10) 1.0  (0.07) 1.0  (0.08)
[1]
Measure Description: The INR is the ratio of a patient's prothrombin time to a normal (control) sample and corrected for the analytical system being used.
1.Primary Outcome
Title Change From Baseline in Serum Alkaline Phosphatase (ALP)
Hide Description The primary efficacy analysis will compare the Week 24 change from Baseline in ALP between OCA treatment group and placebo using an analysis of covariance (ANCOVA) model with fixed effects for treatment group and randomization strata, and Baseline as a covariate.
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title 1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo
Hide Arm/Group Description:

Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.

OCA

Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.

OCA

Subjects randomized to placebo will take placebo daily for 24 weeks.

Placebo

Overall Number of Participants Analyzed 25 26 25
Least Squares Mean (Standard Error)
Unit of Measure: U/L
-105.05  (38.02) -110.19  (33.77) -26.76  (36.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5 mg OCA Titrating to 10 mg OCA, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0434
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model with treatment group and randomization stratification factors as fixed effects and baseline as covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 1.5 mg OCA Titrating to 3 mg OCA, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0665
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model with treatment group and randomization stratification factors as fixed effects and baseline as covariate.
2.Secondary Outcome
Title Change From Baseline in Serum Alanine Transaminase (ALT)
Hide Description [Not Specified]
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat Population
Arm/Group Title 1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo
Hide Arm/Group Description:

Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.

OCA

Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.

OCA

Subjects randomized to placebo will take placebo daily for 24 weeks.

Placebo

Overall Number of Participants Analyzed 25 26 25
Median (Inter-Quartile Range)
Unit of Measure: U/L
-33.0
(-50.5 to 5)
-5.5
(-30.0 to 4.5)
-19.5
(-49.0 to 4.0)
3.Secondary Outcome
Title Change From Baseline in Serum Aspartate Aminotransferase (AST)
Hide Description [Not Specified]
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title 1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo
Hide Arm/Group Description:

Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.

OCA

Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.

OCA

Subjects randomized to placebo will take placebo for 24 weeks.

Placebo

Overall Number of Participants Analyzed 25 26 25
Median (Inter-Quartile Range)
Unit of Measure: U/L
-8.0
(-20.0 to 19.0)
0.5
(-17.5 to 32.8)
-14.0
(-35.5 to 8.0)
4.Secondary Outcome
Title Change From Baseline in Serum Total Bilirubin
Hide Description [Not Specified]
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat Population
Arm/Group Title 1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo
Hide Arm/Group Description:

Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.

OCA

Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.

OCA

Subjects randomized to placebo will take placebo for 24 weeks.

Placebo

Overall Number of Participants Analyzed 25 26 25
Median (Inter-Quartile Range)
Unit of Measure: umol/L
0.8
(-1.7 to 4.3)
1.3
(-1.3 to 6.9)
0.0
(-5.1 to 4.3)
5.Secondary Outcome
Title Change From Baseline in Serum Direct Bilirubin
Hide Description [Not Specified]
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat Population
Arm/Group Title 1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo
Hide Arm/Group Description:

Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.

OCA

Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.

OCA

Subjects randomized to placebo will take placebo for 24 weeks.

Placebo

Overall Number of Participants Analyzed 25 26 25
Median (Inter-Quartile Range)
Unit of Measure: umol/L
0.8
(-0.9 to 0.9)
0.9
(-0.9 to 6.4)
0.0
(-1.7 to 4.3)
6.Secondary Outcome
Title Change From Baseline in Serum Gamma-Glutamyl Transferase (GGT)
Hide Description [Not Specified]
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat Population
Arm/Group Title 1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo
Hide Arm/Group Description:

Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.

OCA

Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.

OCA

Subjects randomized to placebo will take placebo for 24 weeks.

Placebo

Overall Number of Participants Analyzed 25 26 25
Median (Inter-Quartile Range)
Unit of Measure: U/L
-79.0
(-171.0 to -9.7)
-78.5
(-235.5 to 14.0)
-89.0
(-167.0 to 20.0)
7.Secondary Outcome
Title Change From Baseline in Plasma Fibroblast Growth Factor-19 (FGF-19)
Hide Description [Not Specified]
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title 1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo
Hide Arm/Group Description:

Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.

OCA

Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.

OCA

Subjects randomized to placebo will take placebo daily for 24 weeks.

Placebo

Overall Number of Participants Analyzed 25 26 25
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
32.00
(-16.00 to 110.00)
147.00
(-6.35 to 714.50)
-19.50
(-79.56 to 28.00)
8.Secondary Outcome
Title Change From Baseline in Plasma C4
Hide Description [Not Specified]
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat Population
Arm/Group Title 1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo
Hide Arm/Group Description:

Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.

OCA

Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.

OCA

Subjects randomized to placebo will take placebo for 24 weeks.

Placebo

Overall Number of Participants Analyzed 25 26 25
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
-2.80
(-7.50 to 0.55)
-2.90
(-6.94 to -1.12)
0.05
(-2.25 to 10.84)
Time Frame From informed consent to end of double-blind phase study participation, up to 24 weeks
Adverse Event Reporting Description Adverse events reporting is based on the safety population, where treatment group is defined by the treatment actually received. One (1) placebo subject actually received 5mg OCA titrating to 10mg OCA. All adverse event summaries are based on treatment-emergent adverse events.
 
Arm/Group Title 1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo
Hide Arm/Group Description

Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.

OCA

Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.

OCA

Subjects randomized to placebo will take placebo daily for 24 weeks.

Placebo

All-Cause Mortality
1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)      0/27 (0.00%)      0/24 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/25 (16.00%)      4/27 (14.81%)      2/24 (8.33%)    
Gastrointestinal disorders       
Ascites  1  0/25 (0.00%)  0 1/27 (3.70%)  1 1/24 (4.17%)  1
Pancreatitis  1  1/25 (4.00%)  1 0/27 (0.00%)  0 0/24 (0.00%)  0
Oesophageal varices haemorrhage  1  0/25 (0.00%)  0 0/27 (0.00%)  0 1/24 (4.17%)  1
General disorders       
Oedema peripheral  1  1/25 (4.00%)  1 0/27 (0.00%)  0 0/24 (0.00%)  0
Peripheral swelling  1  1/25 (4.00%)  1 0/27 (0.00%)  0 0/24 (0.00%)  0
Hepatobiliary disorders       
Bile duct stenosis  1  1/25 (4.00%)  1 0/27 (0.00%)  0 0/24 (0.00%)  0
Cholangitis  1  0/25 (0.00%)  0 1/27 (3.70%)  1 0/24 (0.00%)  0
Cholangitis acute  1  0/25 (0.00%)  0 1/27 (3.70%)  1 0/24 (0.00%)  0
Hyperbilirubinaemia  1  1/25 (4.00%)  1 0/27 (0.00%)  0 0/24 (0.00%)  0
Cholecystitis acute  1  0/25 (0.00%)  0 0/27 (0.00%)  0 1/24 (4.17%)  1
Infections and infestations       
Cholangitis infective  1  1/25 (4.00%)  1 0/27 (0.00%)  0 0/24 (0.00%)  0
Pharyngitis  1  0/25 (0.00%)  0 1/27 (3.70%)  1 0/24 (0.00%)  0
Pneumonia bacterial  1  0/25 (0.00%)  0 1/27 (3.70%)  1 0/24 (0.00%)  0
Pseudomonal sepsis  1  1/25 (4.00%)  1 0/27 (0.00%)  0 0/24 (0.00%)  0
1
Term from vocabulary, MedDRA (17.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1.5 mg OCA Titrating to 3 mg OCA 5 mg OCA Titrating to 10 mg OCA Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/25 (92.00%)      26/27 (96.30%)      21/24 (87.50%)    
Gastrointestinal disorders       
Nausea  1  2/25 (8.00%)  2 6/27 (22.22%)  7 3/24 (12.50%)  3
Abdominal pain  1  2/25 (8.00%)  2 2/27 (7.41%)  3 4/24 (16.67%)  5
Diarrhoea  1  1/25 (4.00%)  1 3/27 (11.11%)  3 2/24 (8.33%)  3
Abdominal pain upper  1  1/25 (4.00%)  2 2/27 (7.41%)  2 4/24 (16.67%)  4
Ascites  1  1/25 (4.00%)  1 1/27 (3.70%)  2 2/24 (8.33%)  2
Constipation  1  0/25 (0.00%)  0 2/27 (7.41%)  2 0/24 (0.00%)  0
Crohn's disease  1  0/25 (0.00%)  0 2/27 (7.41%)  2 1/24 (4.17%)  1
Vomiting  1  1/25 (4.00%)  1 1/27 (3.70%)  1 4/24 (16.67%)  4
Abdominal distension  1  1/25 (4.00%)  2 0/27 (0.00%)  0 2/24 (8.33%)  2
Frequent bowel movements  1  0/25 (0.00%)  0 0/27 (0.00%)  0 2/24 (8.33%)  3
General disorders       
Pyrexia  1  3/25 (12.00%)  5 4/27 (14.81%)  4 1/24 (4.17%)  1
Fatigue  1  1/25 (4.00%)  2 3/27 (11.11%)  3 2/24 (8.33%)  2
Oedema peripheral  1  1/25 (4.00%)  3 2/27 (7.41%)  2 0/24 (0.00%)  0
Hepatobiliary disorders       
Hyperbilirubinaemia  1  1/25 (4.00%)  1 2/27 (7.41%)  2 0/24 (0.00%)  0
Jaundice  1  2/25 (8.00%)  2 1/27 (3.70%)  1 1/24 (4.17%)  1
Bile duct stenosis  1  2/25 (8.00%)  2 0/27 (0.00%)  0 0/24 (0.00%)  0
Immune system disorders       
Seasonal allergy  1  0/25 (0.00%)  0 2/27 (7.41%)  2 0/24 (0.00%)  0
Infections and infestations       
Sinusitis  1  1/25 (4.00%)  1 3/27 (11.11%)  3 0/24 (0.00%)  0
Urinary tract infection  1  2/25 (8.00%)  2 1/27 (3.70%)  1 2/24 (8.33%)  2
Nasopharyngitis  1  1/25 (4.00%)  1 0/27 (0.00%)  0 3/24 (12.50%)  3
Upper respiratory tract infection  1  0/25 (0.00%)  0 2/27 (7.41%)  2 0/24 (0.00%)  0
Investigations       
Blood bilirubin increased  1  1/25 (4.00%)  1 3/27 (11.11%)  3 3/24 (12.50%)  3
Aspartate aminotransferase increased  1  2/25 (8.00%)  3 0/27 (0.00%)  0 2/24 (8.33%)  2
Metabolism and nutrition disorders       
Decreased appetite  1  0/25 (0.00%)  0 0/27 (0.00%)  0 3/24 (12.50%)  3
Musculoskeletal and connective tissue disorders       
Arthralgia  1  2/25 (8.00%)  5 1/27 (3.70%)  1 1/24 (4.17%)  1
Back pain  1  0/25 (0.00%)  0 0/27 (0.00%)  0 2/24 (8.33%)  2
Nervous system disorders       
Headache  1  2/25 (8.00%)  3 2/27 (7.41%)  2 0/24 (0.00%)  0
Dizziness  1  0/25 (0.00%)  0 2/27 (7.41%)  3 0/24 (0.00%)  0
Paraesthesia  1  0/25 (0.00%)  0 2/27 (7.41%)  2 0/24 (0.00%)  0
Psychiatric disorders       
Insomnia  1  0/25 (0.00%)  0 3/27 (11.11%)  3 1/24 (4.17%)  1
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal pain  1  2/25 (8.00%)  2 3/27 (11.11%)  3 1/24 (4.17%)  1
Cough  1  1/25 (4.00%)  1 1/27 (3.70%)  1 3/24 (12.50%)  3
Nasal congestion  1  0/25 (0.00%)  0 0/27 (0.00%)  0 2/24 (8.33%)  2
Skin and subcutaneous tissue disorders       
Pruritus  1  15/25 (60.00%)  31 18/27 (66.67%)  38 11/24 (45.83%)  17
Urticaria  1  2/25 (8.00%)  2 0/27 (0.00%)  0 0/24 (0.00%)  0
1
Term from vocabulary, MedDRA (17.1)
Indicates events were collected by systematic assessment
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.
Principal Investigators must wait 18 months after the study ends to publish their results and a multi-center publication must come first. The sponsor has a 45 day review period with the option to extend to an additional 90 days.
Results Point of Contact
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Name/Title: Medical Information
Organization: Intercept Pharmaceuticals, Inc.
Phone: 844-782-4278
EMail: medinfo@interceptpharma.com
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Responsible Party: Intercept Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02177136     History of Changes
Other Study ID Numbers: 747-207
First Submitted: June 26, 2014
First Posted: June 27, 2014
Results First Submitted: March 7, 2018
Results First Posted: May 30, 2018
Last Update Posted: May 30, 2018