Primary Biliary CholangitisPhase 2NCT03092765
Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid
A Phase 2 study testing E6011 in people with Primary Biliary Cholangitis, run by EA Pharma Co., Ltd. at 46 sites in Japan.
Trial summary
This study is a placebo-controlled, randomized, double-blind, multicenter, parallel-group comparison study in primary biliary cholangitis participants inadequately responding to ursodeoxycholic acid. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Primary Biliary Cholangitis
- What is being tested?
- E6011
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 46 sitesJapan
- Study dates
- 29 May 2017to 22 Oct 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with primary biliary cholangitis corresponding to one of the following criteria:
- Histologically confirmed chronic non-suppurative destructive cholangitis (CNSDC) with laboratory findings compatible with primary biliary cholangitis (PBC)
- Positivity for antimitochondrial antibodies (AMAs) with histological findings compatible with PBC but in the absence of characteristic histological findings of CNSDC
- No histological findings available, but positivity for AMAs as well as clinical findings and a course indicative of typical cholestatic PBC
- Aged ≥20 and <75 years old at the time of informed consent
- Taking stable dose of ursodeoxycholic acid for at least 6 months (≥600 milligrams [mg]/day) prior to Screening
Show all 9Show fewer
- Screening and Week 0 alkaline phosphatase (ALP) values between 1.67 and 10 times the upper limit of normal
- Outpatient
- Has voluntarily consented, in writing, to participate in this study, and is able to comply with all aspects of the protocol
Who cannot join
- Received the following drugs within 12 weeks before starting the study treatment:
- Drugs that suppose the efficacy to PBC:
- o azathioprine, colchicine, cyclosporine, methotrexate, mycophenolate mofetil, penicillamine, fibrates, and other systemic corticosteroids
- Potentially hepatotoxic drugs o methyl-dopa, sodium valproic acid, and isoniazide
- History or current condition of hepatic decompensation with variceal bleeds, encephalopathy ≥ grade 2 and poorly controlled ascites, and history of liver transplantation
- History or current condition of other concomitant liver diseases including hepatitis due to hepatitis B virus (HBV)/hepatitis C virus (HCV) infection, primary sclerosing cholangitis, alcoholic liver disease (including liver cirrhosis), autoimmune liver disease requiring the treatment of systemic corticosteroids or biopsy proven non-alcoholic steatohepatitis (NASH)
Show all 25Show fewer
- History or current clinical condition of malignant tumor, lymphoma, leukemia, or lymphoproliferative disease, except for skin carcinoma (epithelial carcinoma or basal cell carcinoma) and cervix carcinoma which has completely excised and without metastasis or recurrence for more than 5 years before informed consent
- Immunodeficiency or history of human immunodeficiency virus (HIV) infection
- Infection requiring hospitalization or intravenous administration of antibiotics or disease requiring administration of antivirus drugs (eg, herpes zoster) within 4 weeks before starting the study treatment
- History of tuberculosis or current complication of active tuberculosis
- Positive tuberculosis test (QuantiFERON®TB Gold Test or T-SPOT®.TB Test) at Screening
- History of clinically important vasculitis
- History of severe allergy (shock or anaphylactoid symptoms)
- Complication of uncontrolled disorders such as acute cardiac infarction, unstable angina, brain infarct, or symptomatic intracerebral hemorrhage
- Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, or renal disease) that could affect the participant's safety or interfere with the study assessments in the opinion of the investigator or subinvestigator
- Tested positive for any of the following at Screening: HIV, hepatitis B surface (HBs) antigen, HBs antibody, hepatitis B core (HBc) antibody, HBV deoxyribonucleic acid (DNA), HCV antibody, human T-lymphotropic virus type 1 (HTLV-1) antibody, or syphilis
- Demonstrated prolonged QT interval corrected using Fridericia's formula (QTcF) interval (>450 milliseconds [ms]) in repeated electrocardiogram examinations
- Received immunoglobulin preparations or blood products within 24 weeks before starting the study treatment
- Received a live vaccine within 12 weeks before starting the study treatment, or is planning to receive
- Females who are, or may be pregnant, who are breastfeeding, who wish to become pregnant during the study period, and females or their partners who do not wish to use reliable contraceptive measures.
- Scheduled for surgery before Week 64
- Has been treated with investigational drugs in other E6011 study
- Currently enrolled in another clinical study, including the follow-up
- Used any investigational drug within 28 days (or 5× the half-life, whichever is longer) before informed consent
- Judged to be ineligible to participate in this study by the investigator or sub-investigator
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
Japan46 sites
EA Pharma trial site
Ageo, Saitama
EA Pharma trial site
Bunkyo, Tokyo
EA Pharma trial site #1
Fukuoka
EA Pharma trial site #2
Fukuoka
EA Pharma trial site
Fukushima
EA Pharma trial site
Hirakata, Osaka
EA Pharma trial site #1
Hiroshima
EA Pharma trial site #2
Hiroshima
EA Pharma trial site
Inashiki, Ibaraki
EA Pharma trial site
Iruma, Saitama
EA Pharma trial site
Kagoshima
EA Pharma trial site
Kashihara, Nara
EA Pharma trial site
Kita, Kagawa-ken
EA Pharma trial site
Kobe, Hyōgo
EA Pharma trial site
Kumamoto
EA Pharma trial site
Kurume, Fukuoka
EA Pharma trial site
Kyoto
EA Pharma trial site
Maebashi, Gunma
EA Pharma trial site
Matsudo, Chiba
EA Pharma trial site
Matsumoto, Nagano
EA Pharma trial site #1
Minato, Tokyo
EA Pharma trial site #2
Minato, Tokyo
EA Pharma trial site
Morioka, Iwate
EA Pharma trial site
Musashino, Tokyo
EA Pharma trial site
Nagoya, Aichi-ken
EA Pharma trial site
Nakagami, Okinawa
EA Pharma trial site
Niigata
EA Pharma trial site
Nishinomiya, Hyōgo
EA Pharma trial site
Okayama
EA Pharma trial site
Oomura, Nagasaki
EA Pharma trial site
Osaka
EA Pharma trial site
Saga
EA Pharma trial site #1
Sapporo, Hokkaido
EA Pharma trial site #2
Sapporo, Hokkaido
EA Pharma trial site
Sendai, Miyagi
EA Pharma trial site
Shimotsuga, Tochigi
EA Pharma trial site
Shinjuku, Tokyo
EA Pharma trial site #1
Suita, Osaka
EA Pharma trial site #2
Suita, Osaka
EA Pharma trial site
tabashi City, Tokyo
EA Pharma trial site
Takamatsu, Kagawa-ken
EA Pharma trial site
Touon, Ehime
EA Pharma trial site
Yamagata
EA Pharma trial site #1
Yokohama, Kanagawa
EA Pharma trial site #2
Yokohama, Kanagawa
EA Pharma trial site
Yoshida, Fukui
About this study
Official title: A Clinical Phase 2 Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid
This study is a placebo-controlled, randomized, double-blind, multicenter, parallel-group comparison study in primary biliary cholangitis participants inadequately responding to ursodeoxycholic acid.
- Conditions
- Primary Biliary Cholangitis
- Being tested
- E6011, Placebo
- Keywords
- E6011, Ursodeoxycholic acid, Japan
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E6011Drug
Intravenous administration
PlaceboDrug
Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| low-dose, high-frequency E6011; high-dose, low-frequency E6011 | Experimental | Participants will receive low-dose E6011 at a relatively higher frequency up to approximately Week 12. Participants will then receive high-dose E6011 at a relatively lower frequency from Week 12 to Week 64. Receives: Drug: E6011 |
| low-dose, high-frequency E6011; low-dose, low-frequency E6011 | Experimental | Participants will receive low-dose E6011 at a relatively higher frequency up to approximately Week 12. Participants will then receive low-dose E6011 at a relatively lower frequency from Week 12 to Week 64. Receives: Drug: E6011 |
| high-dose, low-frequency E6011; high-dose, low-frequency E6011 | Experimental | Participants will receive high-dose E6011 at a relatively lower frequency up to approximately Week 12. Participants will then receive high-dose E6011 at a relatively lower frequency from Week 12 to Week 64. Receives: Drug: E6011 |
| high-dose, low-frequency E6011; low-dose, low-frequency E6011 | Experimental | Participants will receive high-dose E6011 at a relatively lower frequency up to approximately Week 12. Participants will then receive low-dose E6011 at a relatively lower frequency from Week 12 to Week 64. Receives: Drug: E6011 |
| low-dose, low-frequency E6011; high-dose, low-frequency E6011 | Experimental | Participants will receive low-dose E6011 at a relatively lower frequency up to approximately Week 12. Participants will then receive high-dose E6011 at a relatively lower frequency from Week 12 to Week 64. Receives: Drug: E6011 |
| low-dose, low-frequency E6011; low-dose, low-frequency E6011 | Experimental | Participants will receive low-dose E6011 at a relatively lower frequency up to approximately Week 12. Participants will then receive low-dose E6011 at a relatively lower frequency from Week 12 to Week 64. Receives: Drug: E6011 |
| Placebo; high-dose, low-frequency E6011 | Experimental | Participants will receive placebo up to approximately Week 12. Participants will then receive high-dose E6011 at a relatively lower frequency from Week 12 to Week 64. Receives: Drug: E6011; Drug: Placebo |
| Placebo; low-dose, low-frequency E6011 | Experimental | Participants will receive placebo up to approximately Week 12. Participants will then receive low-dose E6011 at a relatively lower frequency from Week 12 to Week 64. Receives: Drug: E6011; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change from Baseline in serum alkaline phosphatase (ALP) values at Week 12
This assessment will be conducted as a measure of efficacy.
Measured: Baseline; Week 12
Secondary outcomes (26)
Number of participants with a decrease in ALP response rates of 15%, 20%, and 40% from Baseline
This assessment will be conducted as a measure of efficacy.
Measured: Baseline; up to Week 64
Number of participants with an ALP value less than 1.67 times the upper limit normal and a total bilirubin value within normal limits and a greater than or equal to 15% decrease in ALP from Baseline
This assessment will be conducted as a measure of efficacy.
Measured: Baseline; up to Week 64
Mean values of serum ALP, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) at each visit
This assessment will be conducted as a measure of efficacy.
Measured: Baseline; up to Week 64
Mean values of gamma-guanosine-5'-triphosphate (γGTP) at each visit
This assessment will be conducted as a measure of efficacy.
Measured: Baseline; up to Week 64
Mean values of serum total bilirubin and direct bilirubin at each visit
This assessment will be conducted as a measure of efficacy.
Measured: Baseline; up to Week 64
Mean values of serum total bile acids at each visit
This assessment will be conducted as a measure of efficacy.
Measured: Baseline; up to Week 64
Mean values of serum albumin at each visit
This assessment will be conducted as a measure of efficacy.
Measured: Baseline; up to Week 64
Mean change from Baseline in serum ALP, AST, and ALT at each visit
This assessment will be conducted as a measure of efficacy.
Measured: Baseline; up to Week 64
Mean change from Baseline in serum γGTP at each visit
This assessment will be conducted as a measure of efficacy.
Measured: Baseline; up to Week 64
Mean change from Baseline in serum total bilirubin and direct bilirubin at each visit
This assessment will be conducted as a measure of efficacy.
Measured: Baseline; up to Week 64
Mean change from Baseline in serum total bile acids at each visit
This assessment will be conducted as a measure of efficacy.
Measured: Baseline; up to Week 64
Mean change from Baseline in serum albumin at each visit
This assessment will be conducted as a measure of efficacy.
Measured: Baseline; up to Week 64
Mean rate of change from Baseline in serum ALP, AST, and ALT at each visit
This assessment will be conducted as a measure of efficacy.
Measured: Baseline; up to Week 64
Mean rate of change from Baseline in serum γGTP at each visit
This assessment will be conducted as a measure of efficacy.
Measured: Baseline; up to Week 64
Mean rate of change from Baseline in serum total bilirubin and direct bilirubin at each visit
This assessment will be conducted as a measure of efficacy.
Measured: Baseline; up to Week 64
Mean rate of change from Baseline in serum total bile acids at each visit
This assessment will be conducted as a measure of efficacy.
Measured: Baseline; up to Week 64
Mean rate of change from Baseline in serum albumin at each visit
This assessment will be conducted as a measure of efficacy.
Measured: Baseline; up to Week 64
Mean change from Baseline in individual domain and total primary biliary cholangitis (PBC) version Child-Pugh scores
The Child-Pugh classification is used to assess the prognosis of chronic liver disease. The score employs five clinical measures of liver disease. Each measure is scored from 1 to 3, with 3 indicating most severe derangement. The total score ranges from 5 to 15 and is a sum of the individual domain scores. A higher score indicates a worse prognosis.
Measured: Screening; up to Week 64
Mean change from Baseline in domain (Symptoms, Itch, Fatigue, Cognitive, Emotional, Social) and total scores on the PBC-40
The PBC-40 is measures quality of life. Participants are asked to respond to 40 questions, each of which is scored on a scale of 0 to 5 (where 0=not applicable; 1=least impact; 5=greatest impact), grouped into six domains (symptoms, itch, fatigue, cognition, social, and emotional). For each domain, scoring involves summing individual question response scores. A higher score indicates a poorer quality of life.
Measured: Baseline; up to Week 64
Mean change from Baseline in each score (fibrosis, bile duct loss, deposition of orcein-positive granules) and total scores, in the stage based on the total scores, in each score of cholangitis activity and hepatitis activity on Nakanuma classification
Scores for fibrosis, bile duct loss, and chronic cholestasis are combined for staging: stage 1, total score of 0; stage 2, score 1 to 3; stage 3, score 4 to 6; and stage 4, score 7 to 9. Cholangitis activity and hepatitis activity are graded as CA0-3 and HA0-3, respectively. A higher score indicates more severe disease.
Measured: Screening; Weeks 52 to 60
Mean values of fibrosis marker at each visit
The presence of serum fibrosis markers may be correlated with PBC.
Measured: Baseline; up to Week 64
Mean change from Baseline in fibrosis marker at each visit
The presence of serum fibrosis markers may be correlated with PBC.
Measured: Baseline; up to Week 64
Mean rate of change from Baseline in fibrosis marker at each visit
The presence of serum fibrosis markers may be correlated with PBC.
Measured: Baseline; up to Week 64
Mean values of fibrosis 4 (Fib-4) index at each visit
The presence of serum fibrosis markers may be correlated with PBC.
Measured: Baseline; up to Week 64
Mean change from Baseline in Fib-4 index at each visit
The presence of serum fibrosis markers may be correlated with PBC.
Measured: Baseline; up to Week 64
Mean rate of change from Baseline in Fib-4 index at each visit
The presence of serum fibrosis markers may be correlated with PBC.
Measured: Baseline; up to Week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start29 May 2017
- Primary completion27 Aug 2018
- Study completion22 Oct 2018
Why it stopped: Sponsor's decision (non-safety related)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- EA Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092765
- Sponsor's protocol ID
- E6011/ET1
- Status last verified
- Jul 2018
- First submitted
- 24 Mar 2017
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Phase 2 Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid
- ClinicalTrials.gov ID
- NCT03092765
- Acronym / sponsor ID
- E6011/ET1
- Conditions
- Primary Biliary Cholangitis
- Keywords
- E6011, Ursodeoxycholic acid, Japan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision (non-safety related)
- Enrolment
- 29 participants (actual)
- Lead sponsor
- EA Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2017 (actual)
- Primary completion
- 27 Aug 2018 (actual)
- Study completion
- 22 Oct 2018 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a placebo-controlled, randomized, double-blind, multicenter, parallel-group comparison study in primary biliary cholangitis participants inadequately responding to ursodeoxycholic acid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| low-dose, high-frequency E6011; high-dose, low-frequency E6011 | Experimental | Drug: E6011Participants will receive low-dose E6011 at a relatively higher frequency up to approximately Week 12. Participants will then receive high-dose E6011 at a relatively lower frequency from Week 12 to Week 64. |
| low-dose, high-frequency E6011; low-dose, low-frequency E6011 | Experimental | Drug: E6011Participants will receive low-dose E6011 at a relatively higher frequency up to approximately Week 12. Participants will then receive low-dose E6011 at a relatively lower frequency from Week 12 to Week 64. |
| high-dose, low-frequency E6011; high-dose, low-frequency E6011 | Experimental | Drug: E6011Participants will receive high-dose E6011 at a relatively lower frequency up to approximately Week 12. Participants will then receive high-dose E6011 at a relatively lower frequency from Week 12 to Week 64. |
| high-dose, low-frequency E6011; low-dose, low-frequency E6011 | Experimental | Drug: E6011Participants will receive high-dose E6011 at a relatively lower frequency up to approximately Week 12. Participants will then receive low-dose E6011 at a relatively lower frequency from Week 12 to Week 64. |
| low-dose, low-frequency E6011; high-dose, low-frequency E6011 | Experimental | Drug: E6011Participants will receive low-dose E6011 at a relatively lower frequency up to approximately Week 12. Participants will then receive high-dose E6011 at a relatively lower frequency from Week 12 to Week 64. |
| low-dose, low-frequency E6011; low-dose, low-frequency E6011 | Experimental | Drug: E6011Participants will receive low-dose E6011 at a relatively lower frequency up to approximately Week 12. Participants will then receive low-dose E6011 at a relatively lower frequency from Week 12 to Week 64. |
| Placebo; high-dose, low-frequency E6011 | Experimental | Drug: E6011, Drug: PlaceboParticipants will receive placebo up to approximately Week 12. Participants will then receive high-dose E6011 at a relatively lower frequency from Week 12 to Week 64. |
| Placebo; low-dose, low-frequency E6011 | Experimental | Drug: E6011, Drug: PlaceboParticipants will receive placebo up to approximately Week 12. Participants will then receive low-dose E6011 at a relatively lower frequency from Week 12 to Week 64. |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosed with primary biliary cholangitis corresponding to one of the following criteria:
- Aged ≥20 and <75 years old at the time of informed consent
- Taking stable dose of ursodeoxycholic acid for at least 6 months (≥600 milligrams [mg]/day) prior to Screening
- Screening and Week 0 alkaline phosphatase (ALP) values between 1.67 and 10 times the upper limit of normal
- Outpatient
Key exclusion criteria (25 listed)
- Received the following drugs within 12 weeks before starting the study treatment:
- o azathioprine, colchicine, cyclosporine, methotrexate, mycophenolate mofetil, penicillamine, fibrates, and other systemic corticosteroids
- History or current condition of hepatic decompensation with variceal bleeds, encephalopathy ≥ grade 2 and poorly controlled ascites, and history of liver transplantation
- History or current condition of other concomitant liver diseases including hepatitis due to hepatitis B virus (HBV)/hepatitis C virus (HCV) infection, primary sclerosing cholangitis, alcoholic liver disease (including liver cirrhosis), autoimmune liver disease requiring the treatment of systemic corticosteroids or biopsy proven non-alcoholic steatohepatitis (NASH)
- History or current clinical condition of malignant tumor, lymphoma, leukemia, or lymphoproliferative disease, except for skin carcinoma (epithelial carcinoma or basal cell carcinoma) and cervix carcinoma which has completely excised and without metastasis or recurrence for more than 5 years before informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E6011Intravenous administration | Drug | Placebo; high-dose, low-frequency E6011, Placebo; low-dose, low-frequency E6011, high-dose, low-frequency E6011; high-dose, low-frequency E6011, high-dose, low-frequency E6011; low-dose, low-frequency E6011, low-dose, high-frequency E6011; high-dose, low-frequency E6011, low-dose, high-frequency E6011; low-dose, low-frequency E6011, low-dose, low-frequency E6011; high-dose, low-frequency E6011, low-dose, low-frequency E6011; low-dose, low-frequency E6011 |
| PlaceboIntravenous administration | Drug | Placebo; high-dose, low-frequency E6011, Placebo; low-dose, low-frequency E6011 |
Primary outcome
Rate of change from Baseline in serum alkaline phosphatase (ALP) values at Week 12
Time frame: Baseline; Week 12
This assessment will be conducted as a measure of efficacy.
26 secondary outcomes
Number of participants with a decrease in ALP response rates of 15%, 20%, and 40% from Baseline
Time frame: Baseline; up to Week 64
Number of participants with an ALP value less than 1.67 times the upper limit normal and a total bilirubin value within normal limits and a greater than or equal to 15% decrease in ALP from Baseline
Time frame: Baseline; up to Week 64
Mean values of serum ALP, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) at each visit
Time frame: Baseline; up to Week 64
Mean values of gamma-guanosine-5'-triphosphate (γGTP) at each visit
Time frame: Baseline; up to Week 64
Mean values of serum total bilirubin and direct bilirubin at each visit
Time frame: Baseline; up to Week 64
Mean values of serum total bile acids at each visit
Time frame: Baseline; up to Week 64
Mean values of serum albumin at each visit
Time frame: Baseline; up to Week 64
Mean change from Baseline in serum ALP, AST, and ALT at each visit
Time frame: Baseline; up to Week 64
Mean change from Baseline in serum γGTP at each visit
Time frame: Baseline; up to Week 64
Mean change from Baseline in serum total bilirubin and direct bilirubin at each visit
Time frame: Baseline; up to Week 64
Mean change from Baseline in serum total bile acids at each visit
Time frame: Baseline; up to Week 64
Mean change from Baseline in serum albumin at each visit
Time frame: Baseline; up to Week 64
Mean rate of change from Baseline in serum ALP, AST, and ALT at each visit
Time frame: Baseline; up to Week 64
Mean rate of change from Baseline in serum γGTP at each visit
Time frame: Baseline; up to Week 64
Mean rate of change from Baseline in serum total bilirubin and direct bilirubin at each visit
Time frame: Baseline; up to Week 64
Mean rate of change from Baseline in serum total bile acids at each visit
Time frame: Baseline; up to Week 64
Mean rate of change from Baseline in serum albumin at each visit
Time frame: Baseline; up to Week 64
Mean change from Baseline in individual domain and total primary biliary cholangitis (PBC) version Child-Pugh scores
Time frame: Screening; up to Week 64
Mean change from Baseline in domain (Symptoms, Itch, Fatigue, Cognitive, Emotional, Social) and total scores on the PBC-40
Time frame: Baseline; up to Week 64
Mean change from Baseline in each score (fibrosis, bile duct loss, deposition of orcein-positive granules) and total scores, in the stage based on the total scores, in each score of cholangitis activity and hepatitis activity on Nakanuma classification
Time frame: Screening; Weeks 52 to 60
Mean values of fibrosis marker at each visit
Time frame: Baseline; up to Week 64
Mean change from Baseline in fibrosis marker at each visit
Time frame: Baseline; up to Week 64
Mean rate of change from Baseline in fibrosis marker at each visit
Time frame: Baseline; up to Week 64
Mean values of fibrosis 4 (Fib-4) index at each visit
Time frame: Baseline; up to Week 64
Mean change from Baseline in Fib-4 index at each visit
Time frame: Baseline; up to Week 64
Mean rate of change from Baseline in Fib-4 index at each visit
Time frame: Baseline; up to Week 64
Results and safety
The study was stopped early (reason given: Sponsor's decision (non-safety related)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing E6011 in people with Primary Biliary Cholangitis, run by EA Pharma Co., Ltd. at 46 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor's decision (non-safety related)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change from Baseline in serum alkaline phosphatase (ALP) values at Week 12 (time frame: Baseline; Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.