Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03394924
Registration number
NCT03394924
Ethics application status
Date submitted
23/12/2017
Date registered
9/01/2018
Titles & IDs
Public title
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis
Query!
Scientific title
A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis (PBC) With or Without an Inadequate Response to Ursodeoxycholic Acid (UDCA)
Query!
Secondary ID [1]
0
0
EDP 305-201
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Primary Biliary Cholangitis
0
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - EDP-305 1 mg
Treatment: Drugs - EDP-305 2.5 mg
Treatment: Drugs - Placebo
Experimental: EDP-305 1 mg - Subjects will take 2 tablets once a day orally for 12 weeks
Experimental: EDP-305 2.5 mg - Subjects will take 2 tablets once a day orally for 12 weeks
Placebo comparator: Placebo - Subjects will take two tablets once a day orally for 12 weeks
Treatment: Drugs: EDP-305 1 mg
Two tablets daily for 12 weeks
Treatment: Drugs: EDP-305 2.5 mg
Two tablets daily for 12 weeks
Treatment: Drugs: Placebo
Two tablets daily for 12 weeks
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With At Least a 20% Reduction in Alkaline Phosphatase (ALP) or Normalization of ALP at Week 12 Compared to Baseline
Query!
Assessment method [1]
0
0
Percent change was calculated as \[(ALP at Week 12 - ALP at Baseline)/ALP at Baseline\] \*100. The participant was considered to have successfully achieved a 20% reduction in ALP if the result was =-20. The participant was considered to have successfully achieved ALP normalization if ALP was abnormal at Baseline and normal at Week 12.
Query!
Timepoint [1]
0
0
Baseline and Week 12
Query!
Secondary outcome [1]
0
0
Percentage of Participants With a Treatment-Emergent Adverse Event (TEAE) During On-Treatment Period
Query!
Assessment method [1]
0
0
An adverse event (AE) was defined as any event, side effect, or untoward medical occurrence in a subject enrolled in a clinical trial whether or not it is considered to have a causal relationship to the study drug. A TEAE was an AE that first occurred or began previous to and worsened on or after the first dose date and before the last dose date +7 days.
Query!
Timepoint [1]
0
0
Up to approximately Week 12
Query!
Secondary outcome [2]
0
0
Percentage of Participants With a Treatment-Emergent Serious Adverse Event (SAE) During On-Treatment Period
Query!
Assessment method [2]
0
0
A SAE is any untoward medical occurrence at any dose that results in death, is a life-threatening event, requires inpatient hospitalization or prolonged hospitalization of an existing hospitalization, results in permanent or prolonged disability or incapacity, is a congenital anomaly or birth defect in the offspring of a study subjects, or is a medically important event.
Query!
Timepoint [2]
0
0
Up to approximately Week 12
Query!
Secondary outcome [3]
0
0
Percentage of Participants Who Stopped Study Treatment Due to a Treatment-Emergent Adverse Event (TEAE) During On-Treatment Period
Query!
Assessment method [3]
0
0
An adverse event (AE) was defined as any event, side effect, or untoward medical occurrence in a subject enrolled in a clinical trial whether or not it is considered to have a causal relationship to the study drug. A TEAE was an AE that first occurred or began previous to and worsened on or after the first dose date and before the last dose date +7 days.
Query!
Timepoint [3]
0
0
Up to approximately Week 12
Query!
Secondary outcome [4]
0
0
Change From Baseline to Week 12 in Total, Conjugated and Unconjugated Bilirubin
Query!
Assessment method [4]
0
0
The data presented below was measured using least square mean change from baseline.
Query!
Timepoint [4]
0
0
Baseline and Week 12
Query!
Secondary outcome [5]
0
0
Change From Baseline to Week 12 in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Baseline and Week 12
Query!
Secondary outcome [6]
0
0
Change From Baseline to Week 12 in Noninvasive Liver Fibrosis Markers: Enhanced Liver Fibrosis (ELF) Panel and N-terminal Type III Collagen Propeptide (PRO C3)
Query!
Assessment method [6]
0
0
The ELF panel included hyaluronic acid (HA), procollagen III amino terminal peptide (PIIINP), and tissue inhibitor of metalloproteinase 1 (TIMP 1). This endpoint also presents PRO C3 results.
Query!
Timepoint [6]
0
0
Baseline and Week 12
Query!
Secondary outcome [7]
0
0
Change From Baseline to Week 12 in Noninvasive Liver Fibrosis Markers: AST to Platelet Ratio Index (APRI) Score
Query!
Assessment method [7]
0
0
APRI was calculated as (\[AST level/AST upper limit of normal\]/\[Platelet count 1\^09/L\])×100. AST is aspartate aminotransferase. The aspartate transaminase to platelet ratio index (APRI) is used to assess liver fibrosis in participants with chronic liver disease. Scores range from 0 to = 2.0, with scores \< 0.5 predictive of no liver fibrosis; scores \>1.5 significant fibrosis; and scores \> 2.0 indicative of cirrhosis. A negative change from baseline indicates a decrease in fibrosis.
Query!
Timepoint [7]
0
0
Baseline and Week 12
Query!
Secondary outcome [8]
0
0
Change From Baseline to Week 12 in Noninvasive Liver Fibrosis Markers: Fibrosis-4 (FIB-4) Score
Query!
Assessment method [8]
0
0
Fibrosis-4 is the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score that is calculated using formula: FIB-4 = (Age \[years\] x AST \[U/L\]) / (platelets \[10\^9/L\] x (square root of ALT \[U/L\])). A FIB-4 index of \< 1.45 indicates no or moderate fibrosis and an index of \> 3.25 indicates extensive fibrosis/cirrhosis. A positive change from Baseline indicates increased fibrosis.
Query!
Timepoint [8]
0
0
Baseline and Week 12
Query!
Secondary outcome [9]
0
0
Change From Baseline to Week 12 in Fibrinogen and C Reactive Protein (CRP) Levels
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
Baseline and Week 12
Query!
Secondary outcome [10]
0
0
Change From Baseline to Week 12 in Interleukin (IL) and Tumor Necrosis Factor (TNF) Levels
Query!
Assessment method [10]
0
0
For IL, both IL6 and IL1ß variants were analysed. For TNF, both TNF a and TNF ß (also known as lymphotoxin alpha) variants were analyzed.
Query!
Timepoint [10]
0
0
Baseline and Week 12
Query!
Secondary outcome [11]
0
0
Change From Baseline to Week 12 in Haptoglobin and Alpha2 Macroglobulin Levels
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
Baseline and Week 12
Query!
Secondary outcome [12]
0
0
Change From Baseline to Week 12 in Triglycerides (TG), Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C), Low Density Lipoprotein Cholesterol (LDL-C)
Query!
Assessment method [12]
0
0
Query!
Timepoint [12]
0
0
Baseline and Week 12
Query!
Secondary outcome [13]
0
0
Change From Baseline to Week 12 in Domain and Total Scores on the 5D-Itch Scale
Query!
Assessment method [13]
0
0
The 5D-Itch scale is a multidimensional questionnaire completed by participants to quantify the magnitude of pruritus, assessed considering the past 2 weeks. Scale range is 1 to 5 covering five dimensions: duration (1=Less than 6 hrs/day to 5=All day), degree (1=Not present to 5=Unbearable), direction (1=Completely resolved to 5=Getting worse), disability (for Sleep rated as 1=Never affects sleep to 5=Delays falling asleep and frequently wakes me up at night; for Leisure/Social, Housework/Errands and Work/School rated as 1=Never affects activity to 5=Always affects activity), and distribution (assess if itching is present in 16 body locations, scored as 1=present at 0-2 locations to 5=present at 14-16 locations). Total scores (including highest disability score obtained from any of the daily activities) ranged between 5 and 25 where higher scores indicated more severe itching. Negative change scores indicate improvement from the baseline score.
Query!
Timepoint [13]
0
0
Baseline and Week 12
Query!
Secondary outcome [14]
0
0
Change From Baseline to Week 12 in Visual Analog Score (VAS) for Itching
Query!
Assessment method [14]
0
0
An itch VAS (0-100mm) was used to record the intensity of the event. Participants drew a line on a scale corresponding to the maximum intensity of itch. Lines drawn towards the right of the line indicated greater itching and higher scores indicated more severe itching. Negative change from baseline indicates decrease in itching.
Query!
Timepoint [14]
0
0
Baseline to Week 12
Query!
Secondary outcome [15]
0
0
Change From Baseline to Week 12 in Domain Scores on the Primary Biliary Cholangitis-40 (PBC-40) Quality of Life (QoL) Assessment
Query!
Assessment method [15]
0
0
The PBC-40 is a survey measuring health related quality of life in participants with PBC. The 40 questions from the PBC-40 questionnaire are scored from 1-5, with 5 representing the highest impact and 1 the lowest impact of PBC on the quality of life. Six domains were computed from the 40 questions: symptoms (score range 7-35), itch (0-15), fatigue (11-55), cognition (6-30), social (8-50) and emotional (1-15). Higher scores indicate worse quality of life and negative change scores indicate improvement from the baseline score.
Query!
Timepoint [15]
0
0
Baseline and Week 12
Query!
Secondary outcome [16]
0
0
Maximum Plasma Concentration (Cmax) of EDP-305 and Its Metabolites
Query!
Assessment method [16]
0
0
Metabolites of EDP-305 are EP-022571, EP-022572, and EP-022679.
Query!
Timepoint [16]
0
0
Day 1 and Week 12: Pre-dose and 2, 6 and 8 hours post-dose
Query!
Secondary outcome [17]
0
0
Time to Maximum Plasma Concentration (Tmax) of EDP-305 and Its Metabolites
Query!
Assessment method [17]
0
0
Metabolites of EDP-305 are EP-022571, EP-022572, and EP-022679.
Query!
Timepoint [17]
0
0
Day 1 and Week 12: Pre-dose and 2, 6 and 8 hours post-dose
Query!
Secondary outcome [18]
0
0
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of EDP-305 and Its Metabolites
Query!
Assessment method [18]
0
0
Metabolites of EDP-305 are EP-022571, EP-022572, and EP-022679.
Query!
Timepoint [18]
0
0
Day 1 and Week 12: Pre-dose and 2, 6 and 8 hours post-dose
Query!
Secondary outcome [19]
0
0
Percentage Change From Baseline to Week 12 in Fibroblast Growth Factor 19 (FGF19), 7a-OH-4-cholesten-3-one (C4) and Bile Acid (BA) Concentrations
Query!
Assessment method [19]
0
0
FGF19 was measured in plasma. BA was measured in serum. C4 was measured in serum.
Query!
Timepoint [19]
0
0
Baseline and Week 12
Query!
Secondary outcome [20]
0
0
Percentage Change From Baseline to Week 12 in AUC0-8 and AUC2-8 of Fibroblast Growth Factor 19 (FGF19), 7a-OH-4-cholesten-3-one (C4) and Bile Acid (BA)
Query!
Assessment method [20]
0
0
AUC0-8 is area under the biomarker concentration-time curve from time zero to 8 hours. AUC2-8 is area under the biomarker concentration-time curve from 2 hours to 8 hours. FGF19 was measured in plasma. BA was measured in serum. C4 was measured in serum.
Query!
Timepoint [20]
0
0
Day 1 and Week 12: Pre-dose and 2, 6 and 8 hours post-dose
Query!
Eligibility
Key inclusion criteria
* An informed consent document signed and dated by the subject.
* Male and female subjects of any ethnic origin between the ages of 18 and 75 years, inclusive
* Male or female with a diagnosis of PBC by at least two of the following criteria:
* History of ALP above ULN for at least six months
* Positive Anti-Mitochondrial Antibodies (AMA) titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies)
* For subjects with no documented liver biopsy performed within 2 years, subjects must undergo a transient elastography (Fibroscan) showing liver stiffness < 14.0 kPA
* Must be on a stable dose of UDCA12-20 mg/kg/day for at least 6 months prior to Screening or intolerant of UDCA in the opinion of the Investigator (no UDCA for at least 12 weeks prior to Screening)
* Alkaline Phosphatase (ALP) = 1.67 × ULN and/or total bilirubin >ULN but < 2×ULN (<2.4 mg/dL)
* Subjects must have Screening laboratory values for Hepatitis B surface antigen (HBsAg), anti-HCV antibodies and HCV RNA negative and Human Immunodeficiency Virus (HIV) 1 and 2 antibodies (Ab) as seronegative. Note: subjects previously infected by chronic hepatitis C and treated with direct acting antivirals (DAAs) with sustained virologic response (SVR) for at least 3 years will be allowed.
* Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP-305.
* All male participants who have not had a vasectomy must use effective contraception from Day -1 to 90 days after their last dose of study drug.
* Male subjects must agree to refrain from sperm donation from the date of Screening until 90 days after their last dose of study drug
* Screening body mass index (BMI) of =18 kg/m2
* Subject must be willing and able to adhere to the assessments, visit schedule, prohibitions and restrictions, as described in this protocol
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Laboratory Screening Results:
* AST >5 x ULN
* ALT >5 x ULN
* Patients with Gilbert's syndrome will not be allowed due to interpretability of bilirubin levels
* Total white blood cells (WBC) <3000 cells/mm3
* Absolute neutrophil count (ANC) <1500 cells/mm3
* Platelet count <140,000/mm3
* Prothrombin time (international normalized ratio, INR) >1.2
* Serum creatinine >2 mg/dL or creatinine clearance <60 mL/min (based on Cockroft-Gault Method)
* Suspected to have relevant nonalcoholic fatty liver disease (NAFLD) as based on the judgment of the Investigator at Screening
* Use of immunosuppressants known to have an effect on the liver of patients with PBC (eg, colchicine, methotrexate, azathioprine, or systemic steroids) in the three months preceding screening
* Current use of fibrates, including fenofibrates. Note: Subjects who discontinued fibrates for at least 3 months before Screening can participate
* Use of an experimental treatment for PBC within the past 6 months
* Co-existing liver or biliary diseases, such as primary sclerosing cholangitis, choledocholithiasis, acute or chronic hepatitis, autoimmune hepatitis, alcoholic liver disease, nonalcoholic steatohepatitis (NASH), acute infection of bile duct system or gall bladder, history of gastrointestinal bleeding (secondary to portal hypertension), cirrhosis, cholangiocarcinoma diagnosed or suspected liver cancers
* Cirrhosis with or without complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma
* Hepatorenal syndrome (type I or II) or Screening serum creatinine > 2 mg/dL (178 µmol/L)
* Prior variceal hemorrhage, uncontrolled encephalopathy, Child-Pugh Class A, B and C, esophageal varices, or refractory ascites within the previous 6 months of Screening (defined as date informed consent signed)
* Medical conditions that may cause nonhepatic increases in ALP (e.g., Paget's disease)
* Use of a new statin regimen from Screening and throughout study duration. NOTE: Subjects on a stable dose of statins for at least 3 months prior to Screening are allowed. No dose modification during the study will be allowed.
* Use of immunosuppressants (eg, systemic corticosteroids) for more than 2 consecutive weeks in duration within 1 year prior to Screening.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
27/12/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
16/01/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
68
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Query!
Recruitment hospital [1]
0
0
Nepean Hospital - Kingswood
Query!
Recruitment hospital [2]
0
0
Monash Medical Centre - Clayton
Query!
Recruitment hospital [3]
0
0
Linear Clinical Research - Perth
Query!
Recruitment postcode(s) [1]
0
0
2747 - Kingswood
Query!
Recruitment postcode(s) [2]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [3]
0
0
6000 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Iowa
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Louisiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Maryland
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Massachusetts
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Michigan
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Nebraska
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New Hampshire
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New York
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Pennsylvania
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Texas
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Virginia
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Washington
Query!
Country [21]
0
0
Austria
Query!
State/province [21]
0
0
Carinthia
Query!
Country [22]
0
0
Austria
Query!
State/province [22]
0
0
Tyrol
Query!
Country [23]
0
0
Austria
Query!
State/province [23]
0
0
Upper Austria
Query!
Country [24]
0
0
Belgium
Query!
State/province [24]
0
0
Liege
Query!
Country [25]
0
0
Belgium
Query!
State/province [25]
0
0
Limburg
Query!
Country [26]
0
0
Belgium
Query!
State/province [26]
0
0
Oost-vlaanderen
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
Ontario
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Alsace
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Aquitaine
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Ile-de-france
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Languedoc-roussillon
Query!
Country [32]
0
0
France
Query!
State/province [32]
0
0
NORD Pas-de-calais
Query!
Country [33]
0
0
France
Query!
State/province [33]
0
0
Picardie
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
Rhone-alpes
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Bayern
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Hessen
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Nordrhein-westfalen
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Rheinland-pfalz
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Sachsen
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Berlin
Query!
Country [41]
0
0
Netherlands
Query!
State/province [41]
0
0
Noord-holland
Query!
Country [42]
0
0
Netherlands
Query!
State/province [42]
0
0
Zuid-holland
Query!
Country [43]
0
0
Netherlands
Query!
State/province [43]
0
0
Utrecht
Query!
Country [44]
0
0
Spain
Query!
State/province [44]
0
0
Guipuzcoa
Query!
Country [45]
0
0
Spain
Query!
State/province [45]
0
0
Murcia
Query!
Country [46]
0
0
Spain
Query!
State/province [46]
0
0
Barcelona
Query!
Country [47]
0
0
Spain
Query!
State/province [47]
0
0
Madrid
Query!
Country [48]
0
0
Spain
Query!
State/province [48]
0
0
Santander
Query!
Country [49]
0
0
Spain
Query!
State/province [49]
0
0
Sevilla
Query!
Country [50]
0
0
Spain
Query!
State/province [50]
0
0
Valencia
Query!
Country [51]
0
0
Spain
Query!
State/province [51]
0
0
Valladolid
Query!
Country [52]
0
0
United Kingdom
Query!
State/province [52]
0
0
England
Query!
Country [53]
0
0
United Kingdom
Query!
State/province [53]
0
0
Scotland
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Enanta Pharmaceuticals, Inc
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Pharmaceutical Research Associates
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
Triangle Biostatistics
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis
Query!
Trial website
https://clinicaltrials.gov/study/NCT03394924
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/24/NCT03394924/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/24/NCT03394924/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03394924