Thrombocytopenia Associated With Chronic Liver DiseasePhase 2NCT02227693
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Once-daily Oral Avatrombopag in Japanese Subjects With Chronic Liver Diseases and Thrombocytopenia
A Phase 2 study testing avatrombopag in people with Thrombocytopenia Associated With Chronic Liver Disease, run by Eisai Co., Ltd. at 14 sites in Japan.
Trial summary
This is a phase 2, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag for Japanese subjects with thrombocytopenia associated with chronic liver disease. This study will assess the effect of avatrombopag on platelet counts in Japanese subjects. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Thrombocytopenia Associated With Chronic Liver Disease
- What is being tested?
- avatrombopag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 14 sitesJapan
- Study dates
- Jul 2014to 1 Apr 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese subjects greater than or equal to 20 years of age at Screening with chronic liver disease.
- Subjects who have a mean baseline platelet count of less than 50 x 10^9/L. Platelet counts will be measured on 2 separate occasions, during the Screening Period and at Baseline, and must be performed at least one day apart with neither platelet count greater than 60 x 10^9/L.
- Model For End-stage Liver Disease (MELD) score 24 at Screening.
- If taking inhibitors of P glycoprotein (P-gp), except for verapamil, dose must be stable for 7 days prior to Screening.
- Provide written informed consent.
- Willing and able to comply with all aspects of the protocol.
Who cannot join
- Any history of arterial or venous thrombosis, including partial or complete thrombosis.
- Evidence of thrombosis (partial or complete) in the main portal vein, portal vein branches, or any part of the splenic mesenteric system at Screening.
- Portal vein blood flow velocity rate less than 10 cm/second at Screening.
- Hepatic encephalopathy that cannot be effectively treated.
- Subjects with HCC with Barcelona Clinic Liver Cancer (BCLC) staging classification C or D.
- Platelet transfusion or receipt of blood products containing platelets within 7 days of Screening. However packed red blood cells are permitted.
Show all 28Show fewer
- Heparin, warfarin, nonsteroidal anti-inflammatory drugs (NSAID), aspirin, verapamil, and antiplatelet therapy with ticlopidine or glycoprotein IIb/IIIa antagonists (eg, tirofiban) within 7 days of Screening.
- Use of erythropoietin stimulating agents within 7 days of Screening.
- Interferon (IFN) use within 14 days of Screening.
- Estrogen-containing hormonal contraceptive or hormone replacement therapy use within 30 days of Screening.
- Active infection requiring systemic antibiotic therapy within 7 days of Screening. However, prophylactic use of antibiotics is permitted.
- Alcohol abuse, alcohol dependence syndrome, drug abuse, or drug dependence within 6 months of the study start (unless participating in a controlled rehabilitation program) or acute alcoholic hepatitis (chronic alcoholic hepatitis is allowed) within 6 months of the study start.
- Known to be human immunodeficiency virus positive.
- Any clinically significant acute or active bleeding (eg, gastrointestinal, central nervous system).
- Known history of any primary hematologic disorder (eg, immune thrombocytopenic purpura, myelodysplastic syndrome).
- Known medical history of genetic prothrombotic syndromes (eg, Factor V Leiden; prothrombin G20210A; ATIII deficiency etc.)
- Subjects with a history of significant cardiovascular disease (eg, congestive heart failure New York Heart Association Grade III/IV, arrhythmia known to increase the risk of thromboembolic events [eg, atrial fibrillation], coronary artery stent placement, angioplasty, and coronary artery bypass grafting).
- Females of childbearing potential who have had unprotected sexual intercourse within 30 days before study entry and who do not agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a progesterone only contraceptive implant/injection, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 30 days after study drug discontinuation. If currently abstinent, the subject must agree to use a double barrier method as described above if she becomes sexually active during the study period or for 30 days after study drug discontinuation. All females will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months consecutive amenorrhea in the appropriate age group and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, hysterectomy, or bilateral oophorectomy) at least 1 month before dosing.
- Females who are lactating or pregnant at Screening or Baseline (as documented by a positive serum beta-human chorionic gonadotropin [B-hCG] test with a minimum sensitivity 25 IU/L or equivalent units of B-hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
- Post liver transplant subjects.
- Any subject who has previously received avatrombopag.
- Hypersensitivity to avatrombopag maleate or any of its excipients.
- Hemoglobin levels less than or equal to 8.0 or greater than or equal to 16.0 g/dL at Screening.
- White blood cell count less than or equal to 1.5 x 10^9/L or greater than or equal to 15.0 x 10^9/L at Screening.
- Serum sodium level less than or equal to 130 milliequivalents/L at Screening.
- Current malignancy including solid tumors and hematologic malignancies (except HCC).
- Any history of a medical condition or a concomitant medical condition that, in the opinion of the investigator(s), would compromise the subject's ability to safely complete the study.
- Currently enrolled in another clinical trial or used any investigational drug or device within 30 days of Screening.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Japan14 sites
Study site
Fukuoka
Study site
Iizuka, Fukuoka
Study site
Ikeda, Osaka
Study site
Kitakyushu, Fukuoka
Study site
Kumamoto
Study site
Kure, Hiroshima
Study site
Kurume, Fukuoka
Study site
Matsuyama, Ehime
Study site
Minato-Ku, Tokyo
Study site
Osaka
Study site
Sagamihara, Kanagawa
Study site
Sapporo, Hokkaido
Study site
Takatsuki, Osaka
Study site
Yamanashi
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Once-daily Oral Avatrombopag in Japanese Subjects With Chronic Liver Disease and Thrombocytopenia
This is a phase 2, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag for Japanese subjects with thrombocytopenia associated with chronic liver disease. This study will assess the effect of avatrombopag on platelet counts in Japanese subjects. Subjects will be enrolled into 2 cohorts according to the mean platelet count measured at Screening and Baseline. Within the lower baseline platelet count cohort (less than 40 x 10^9/L), subjects will be randomized in a 1:1:1:3 ratio to receive placebo, 20 mg avatrombopag, 40 mg avatrombopag, or 60 mg avatrombopag for 5 days. Within the higher baseline platelet count cohort (from 40 to less than 50 x 10^9/L), subjects will be randomized in a 2:1:2 ratio to receive placebo, 20 mg avatrombopag, or 40 mg avatrombopag for 5 days.
Read the detailed description
This study will consist of Prerandomization Phase and Randomization Phase. The Prerandomization Phase includes a Screening Period (Day -28 to Day -1) and a Baseline Period (Day 1). During the Prerandomization Phase, participants will be divided into two cohorts based on the platelet count: Low Platelet Count Cohort and High Platelet Count Cohort. Participants in Low Platelet Count Cohort will be randomized to receive one of the four treatments: Placebo, Avatrombopag 20 mg, Avatrombopag 40 mg, or Avatrombopag 60 mg. Participants in High Platelet Count Cohort will be randomized to receive one of the three treatments: Placebo, Avatrombopag 20 mg, or Avatrombopag 40 mg.
The Randomization Phase includes the Treatment Period and the Follow-up Period. The Follow-up Period comprises 3 visits: Visit 4 (5 to 8 days after last dose of study drug [Study Day 10 to 13]), Visit 5 (12 to 15 days after last dose of study drug [Study Day 17 to 20]), and 30 days after receiving the last dose of study drug.
- Being tested
- avatrombopag, Placebo
- Keywords
- Thrombocytopenia, Chronic Liver Disease
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
avatrombopagDrug
E5501 (avatrombopag) 20-mg tablets
PlaceboDrug
Placebo matching 20-mg tablets
| Study group | Role | What they receive |
|---|---|---|
| avatrombopag 20-mg | Experimental | 20 mg avatrombopag (1 x 20 mg tablet and 2 x 20 mg matching placebo tablets) once daily on Days 1 through 5 Receives: Drug: avatrombopag |
| avatrombopag 40-mg | Experimental | 40 mg avatrombopag (2 x 20 mg tablets and 1 x 20 mg matching placebo tablet) once daily on Days 1 through 5 Receives: Drug: avatrombopag |
| avatrombopag 60-mg | Experimental | 60 mg avatrombopag (3 x 20 mg tablets) once daily on Days 1 through 5 Receives: Drug: avatrombopag |
| placebo l | Placebo comparator | Placebo (3 x 20-mg matching placebo tablets) once daily on Days 1 through 5 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Platelet Count Greater Than or Equal to 50 x 10^9/L and at Least 20 x 10^9/L Increase From Baseline at Visit 4
Responders were defined as participants whose platelet count was greater than or equal to 50×10^9/liter (L) and change from baseline was at least 20×10^9/L at Visit 4. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis. Two-sided 95% confidence interval (CI) is calculated by Clopper and Pearson method.
Measured: Baseline and Visit 4 (Day 10)
Secondary outcomes (5)
Percentage of Participants With Platelet Count Greater Than or Equal to 50 x 10^9/L at Each Visit
Responders were defined as the participants whose platelet count greater than or equal to 50 x 10^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis. Two-sided 95% CI is calculated by Clopper and Pearson method.
Measured: Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)
Percentage of Participants With Platelet Count Greater Than or Equal to 75 x 10^9/L at Each Visit
Responders were defined as the participants whose platelet count greater than or equal to 75 x 10^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis. Two-sided 95% CI is calculated by Clopper and Pearson method.
Measured: Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)
Percentage of Participants With Platelet Count Greater Than or Equal to 150 x 10^9/L At Each Visit
Responders were defined as the participants whose platelet count greater than or equal to 150 x 10^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis.
Measured: Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)
Percentage of Participants With Platelet Count Greater Than or Equal to 200 x 10^9/L At Each Visit
Responders were defined as the participants whose platelet count greater than or equal to 200 x 10^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis.
Measured: Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)
Platelet Count and Change From Baseline in Platelet Count by Visit
Measured: Baseline, Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startJul 2014
- Primary completion1 Apr 2015
- Study completion1 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thrombocytopenia Associated With Chronic Liver DiseaseStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227693
- Sponsor's protocol ID
- E5501-J081-204
- Status last verified
- Dec 2017
- First submitted
- 26 Aug 2014
- Last updated
- 28 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Eguchi Y, Takahashi H, Mappa S, Santagostino E. Phase 2 study of avatrombopag in Japanese patients with chronic liver disease and thrombocytopenia. Hepatol Res. 2022 Apr;52(4):371-380. doi: 10.1111/hepr.13755. Epub 2022 Feb 21.
PubMed 35134259
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Once-daily Oral Avatrombopag in Japanese Subjects With Chronic Liver Disease and Thrombocytopenia
- ClinicalTrials.gov ID
- NCT02227693
- Acronym / sponsor ID
- E5501-J081-204
- Keywords
- Thrombocytopenia, Chronic Liver Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2014 (actual)
- Primary completion
- 1 Apr 2015 (actual)
- Study completion
- 1 Apr 2015 (actual)
- First posted
- 28 Aug 2014 (estimated)
- Results
- Posted 28 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag for Japanese subjects with thrombocytopenia associated with chronic liver disease. This study will assess the effect of avatrombopag on platelet counts in Japanese subjects. Subjects will be enrolled into 2 cohorts according to the mean platelet count measured at Screening and Baseline. Within the lower baseline platelet count cohort (less than 40 x 10^9/L), subjects will be randomized in a 1:1:1:3 ratio to receive placebo, 20 mg avatrombopag, 40 mg avatrombopag, or 60 mg avatrombopag for 5 days. Within the higher baseline platelet count cohort (from 40 to less than 50 x 10^9/L), subjects will be randomized in a 2:1:2 ratio to receive placebo, 20 mg avatrombopag, or 40 mg avatrombopag for 5 days.
Detailed description
This study will consist of Prerandomization Phase and Randomization Phase. The Prerandomization Phase includes a Screening Period (Day -28 to Day -1) and a Baseline Period (Day 1). During the Prerandomization Phase, participants will be divided into two cohorts based on the platelet count: Low Platelet Count Cohort and High Platelet Count Cohort. Participants in Low Platelet Count Cohort will be randomized to receive one of the four treatments: Placebo, Avatrombopag 20 mg, Avatrombopag 40 mg, or Avatrombopag 60 mg. Participants in High Platelet Count Cohort will be randomized to receive one of the three treatments: Placebo, Avatrombopag 20 mg, or Avatrombopag 40 mg.
The Randomization Phase includes the Treatment Period and the Follow-up Period. The Follow-up Period comprises 3 visits: Visit 4 (5 to 8 days after last dose of study drug [Study Day 10 to 13]), Visit 5 (12 to 15 days after last dose of study drug [Study Day 17 to 20]), and 30 days after receiving the last dose of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| avatrombopag 20-mg | Experimental | Drug: avatrombopag20 mg avatrombopag (1 x 20 mg tablet and 2 x 20 mg matching placebo tablets) once daily on Days 1 through 5 |
| avatrombopag 40-mg | Experimental | Drug: avatrombopag40 mg avatrombopag (2 x 20 mg tablets and 1 x 20 mg matching placebo tablet) once daily on Days 1 through 5 |
| avatrombopag 60-mg | Experimental | Drug: avatrombopag60 mg avatrombopag (3 x 20 mg tablets) once daily on Days 1 through 5 |
| placebo l | Placebo comparator | Drug: PlaceboPlacebo (3 x 20-mg matching placebo tablets) once daily on Days 1 through 5 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Japanese subjects greater than or equal to 20 years of age at Screening with chronic liver disease.
- Subjects who have a mean baseline platelet count of less than 50 x 10^9/L. Platelet counts will be measured on 2 separate occasions, during the Screening Period and at Baseline, and must be performed at least one day apart with neither platelet count greater than 60 x 10^9/L.
- Model For End-stage Liver Disease (MELD) score 24 at Screening.
- If taking inhibitors of P glycoprotein (P-gp), except for verapamil, dose must be stable for 7 days prior to Screening.
- Provide written informed consent.
Key exclusion criteria (28 listed)
- Any history of arterial or venous thrombosis, including partial or complete thrombosis.
- Evidence of thrombosis (partial or complete) in the main portal vein, portal vein branches, or any part of the splenic mesenteric system at Screening.
- Portal vein blood flow velocity rate less than 10 cm/second at Screening.
- Hepatic encephalopathy that cannot be effectively treated.
- Subjects with HCC with Barcelona Clinic Liver Cancer (BCLC) staging classification C or D.
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 |
|---|---|---|
| avatrombopagE5501 (avatrombopag) 20-mg tablets | Drug | avatrombopag 20-mg, avatrombopag 40-mg, avatrombopag 60-mg |
| PlaceboPlacebo matching 20-mg tablets | Drug | placebo l |
Primary outcome
Percentage of Participants With Platelet Count Greater Than or Equal to 50 x 10^9/L and at Least 20 x 10^9/L Increase From Baseline at Visit 4
Time frame: Baseline and Visit 4 (Day 10)
Responders were defined as participants whose platelet count was greater than or equal to 50×10^9/liter (L) and change from baseline was at least 20×10^9/L at Visit 4. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis. Two-sided 95% confidence interval (CI) is calculated by Clopper and Pearson method.
5 secondary outcomes
Percentage of Participants With Platelet Count Greater Than or Equal to 50 x 10^9/L at Each Visit
Time frame: Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)
Percentage of Participants With Platelet Count Greater Than or Equal to 75 x 10^9/L at Each Visit
Time frame: Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)
Percentage of Participants With Platelet Count Greater Than or Equal to 150 x 10^9/L At Each Visit
Time frame: Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)
Percentage of Participants With Platelet Count Greater Than or Equal to 200 x 10^9/L At Each Visit
Time frame: Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)
Platelet Count and Change From Baseline in Platelet Count by Visit
Time frame: Baseline, Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35134259Eguchi Y, Takahashi H, Mappa S, Santagostino E. Phase 2 study of avatrombopag in Japanese patients with chronic liver disease and thrombocytopenia. Hepatol Res. 2022 Apr;52(4):371-380. doi: 10.1111/hepr.13755. Epub 2022 Feb 21.
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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.
14 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 avatrombopag in people with Thrombocytopenia Associated With Chronic Liver Disease, run by Eisai Co., Ltd. at 14 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 6 inclusion and 28 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: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 28 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Platelet Count Greater Than or Equal to 50 x 10^9/L and at Least 20 x 10^9/L Increase From Baseline at Visit 4 (time frame: Baseline and Visit 4 (Day 10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02227693, which also lists 1 linked publication.
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 28 Feb 2019.