Chronic Idiopathic Thrombocytopenic PurpuraPhase 2NCT00441090
Study of AKR-501 Tablets Taken Orally Once Daily for 28 Days in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
A Phase 2 study testing Avatrombopag tablets in people with Chronic Idiopathic Thrombocytopenic Purpura and Purpura, Thrombocytopenic, Idiopathic, run by Eisai Inc. at 25 sites in United States.
Trial summary
The purpose of this study is to determine the efficacy, safety and tolerability, of AKR-501 (avatrombopag) tablets, as compared to placebo, in the treatment of participants with chronic Idiopathic Thrombocytopenic Purpura (ITP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Idiopathic Thrombocytopenic Purpura, Purpura, Thrombocytopenic, Idiopathic
- What is being tested?
- Avatrombopag tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 25 sitesUnited States
- Study dates
- Feb 2007to Jun 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥ 18 years of age.
- Confirmed diagnosis of ITP according to American Society of Hematology (ASH) Guidelines ≥ 3 months prior to Day 1.
- If ≥ 60 years old, must have had either a bone marrow biopsy consistent with ITP within past 3 years or a good response (platelet count > 100,000/mm^3) to a previous ITP treatment.
- Are refractory or relapsed after at least one prior ITP therapy (patients who are refractory and failed to achieve a platelet count ≥ 50,000/mm^3 despite steroids or ≥ 30,000/mm^3 to other prior ITP therapies, such as splenectomy, danazol, or immunosuppressive drugs. For patients who are relapsed, the platelet counts must be below 50,000/mm^3 if using steroids or 30,000/mm^3 if not prescribed steroids.)
- Patients receiving maintenance corticosteroids may be enrolled, as long as the corticosteroids have been administered at a stable dose (same milligram amount ± 10%) for ≥ 2 weeks prior to Screening Visit A and the investigator does not foresee the need to change the steroid dose during study participation. Patients should remain on this stable corticosteroid dose during study participation.
- Patients receiving stable dosages of cyclosporine A, mycophenolate mofetil, azathioprine or danazol may also be enrolled. The dosages of all these medications must be stable for at least 3 months prior to AKR-501 administration.
Show all 12Show fewer
- Platelet count:
- Patients not receiving steroids (no steroid treatment for > 2 weeks prior to the Screening Visit A): platelets < 30,000/mm^3 at Screening Visit A and within 96 hours prior to Day 1 (Screening Visit B)
- Patients receiving steroids: platelets < 50,000/mm^3 at Screening Visit A and within 96 hours prior to Day 1 (Screening Visit B).
- Women of child-bearing potential must have a negative pregnancy test at Screening Visit A and Screening Visit B. (Childbearing potential is defined as any woman who has not been surgically sterilized and is premenopausal or peri-menopausal i.e., any menstrual flow within 12 months of Screening Visit A).
- Women of child-bearing potential and all men must agree to practice a medically approved form of contraception (one of the following must be used: condoms (male or female) with a spermicidal agent, diaphragm, or cervical cap with a spermicidal agent, IUD, hormonal contraception, abstinence).
- Willing and able to provide written informed consent before any study-related procedure.
Who cannot join
- Women who are pregnant and/or lactating.
- Splenectomy procedure performed 4 weeks prior to AKR-501 administration.
- Use of the following drugs or treatments prior to Day 1:
- Within 3 months - Rituximab;
- Within 2 weeks - Aspirin or Aspirin-containing compounds, Salicylates, Anticoagulants, clopidogrel, ticlopidine, Rh0(D) Immune Globulin (WinRho®), or intravenous immunoglobulin (IVIG).
- Participation in a clinical trial involving any investigational agent within 4 weeks of Day 1.
Show all 30Show fewer
- Exposure to eltrombopag or AMG -531.
- Significant medical conditions or diseases as determined by the Investigator (e.g., clinically active systemic lupus erythematosus; known or suspected HIV infection; acute hepatitis or clinically active chronic hepatitis; lymphoproliferative disease; congestive heart failure).
- History of cardiovascular disease (e.g., angina, unstable angina, myocardial infraction, coronary artery stent placement, angioplasty, coronary artery bypass grafting).
- History of thromboembolic disease (e.g., transient ischemic attack [TIA], stroke [CVA], pulmonary embolism [PE]).
- History of deep venous thrombosis (DVT).
- History of lupus anticoagulant or anticardiolipin antibody syndrome or positive anti b2 glycoprotein antibody.
- History of any medical condition where systemic anticoagulation was required for more than 6 months.
- Laboratory abnormalities:
- Hemoglobin < 12.5 g/dL for men and < 11.5 g/dL for women. If anemia is clearly related to ITP, for example excessive blood loss, then that patient may be enrolled without the need for a waiver after discussion with the Sponsor's medical monitor
- White blood cell count (WBC) < lower limit of normal
- Absolute neutrophil count (ANC) < 1000/mm^3
- Prothrombin time (PT) > 1.25 x upper limit of normal
- Partial thromboplastin time (PTT) > 1.25 x upper limit of normal
- Total bilirubin > 3 x upper normal limit
- Alanine transaminase (ALT) > 3 x upper normal limit
- Aspartate transaminase (AST) > 3 x upper normal limit
- Creatinine > 1.5x upper normal limit
- Blood urea nitrogen (BUN) > 1.5 x upper normal limit
- HIV positive
- IgM HAV positive, Hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV) positive.
- History of, or current alcohol or drug abuse likely to interfere with ability to comply with protocol.
- requirements or give informed consent, as determined by the Investigator.
- History of, or current psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent, as determined by the Investigator.
- Currently taking any of the following medications: Rituximab, Aspirin or Aspirin-containing compounds, Salicylates, Anticoagulants, clopidogrel, ticlopidine, Rh0(D) Immune Globulin (WinRho®), or intravenous immunoglobulin (IVIG).
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Pacific Cancer Medical Center, Inc
Anaheim, California, 92801
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
Johns Hopkins University
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
John H. Stroger, Jr. Hospital of Cook County, Div. of Hematology and Oncology
Chicago, Illinois, 60612
Columbus Clinic, PC
Columbus, Georgia, 31901
Mid Ohio Oncology/Hematology, Inc., dba The Mark H. Zangmeister Center
Columbus, Ohio, 43219
Bay Area Cancer Research Group, LLC
Concord, California
Pacific Coast Hematology/Oncology Medical Group Inc.
Fountain Valley, California, 92708
Cancer Centers of the Carolina
Greenville, South Carolina, 29605
Emerywood Oncology and Hematology
High Point, North Carolina, 27262
Capitol Comprehensive Cancer Care Clinic
Jefferson City, Missouri, 65109
Kansas City Cancer Center, LLC
Kansas City, Missouri, 64131
Davis, Posteraro and Wasser, MDs, LLP
Manchester, Connecticut, 06105
Cancer Care Center, Inc.
New Albany, Indiana, 47150
UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Florida Cancer Institute
New Port Richey, Florida, 34655
Mount Sinai Medical Center
New York, New York, 10029
New York Presbyterian Hospital, Weill Medical College of Cornell University
New York, New York, 10032
University of California Irvine Cancer Center
Orange, California, 92618
Comprehensive Bleeding Disorders Center
Peoria, Illinois, 61614
UPENN
Philadelphia, Pennsylvania, 19104
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15212
Puget Sound Blood Center
Seattle, Washington, 98014
Georgetown University
Washington D.C., District of Columbia
About this study
Official title: A Phase 2 Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled, Parallel Group Study of AKR-501 Tablets Taken Orally Once Daily for 28 Days in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP).
The purpose of this study is to determine the efficacy, safety and tolerability, of AKR-501 (avatrombopag) tablets, as compared to placebo, in the treatment of participants with chronic Idiopathic Thrombocytopenic Purpura (ITP).
Read the detailed description
This is a Phase 2, multi-center, double-blind, randomized, placebo-controlled, dose-ranging, parallel-group study. The pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) relationship of avatrombopag will also be studied. Approximately 65 eligible participants will be randomized in a 3:3:3:3:1 ratio in a double-blinded fashion into one of five parallel treatment groups to receive daily doses of either avatrombopag 2.5, 5, 10 or 20 mg or placebo for 28 days, respectively. Each avatrombopag dosing group will consist of 15 participants while the placebo group will consist of 5 participants. All study participants will be evaluated weekly (Days 3, 5, 7, 14, 21 and 28) for safety, efficacy, and (Days 7, 14, 21, and 28) avatrombopag PK while receiving study treatment with a final assessment for safety and effectiveness to be done 2 weeks after the last study dose (Day 42).
At the completion of Visit Day 28±1, participants who complete 28±1 days of study dosing will be assessed for eligibility to enroll into the rollover Study 501-CL-004 (NCT00625443) based on this visit.
- Being tested
- Placebo, Avatrombopag tablets
- Keywords
- Chronic Idiopathic Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura, ITP
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo tablets 2.5, 5, 10 and 20 mg taken orally once daily for 28 days.
Avatrombopag tabletsDrug
Also called AKR-501, E5501, YM477
Avatrombopag tablets 2.5, 5, 10 and 20 mg taken orally once daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Avatrombopag tablets | Experimental | 2.5, 5, 10 or 20 mg tablets
1 tablet taken orally once daily for 28 days Receives: Drug: Avatrombopag tablets |
| Placebo tablet | Placebo comparator | 2.5, 5, 10, or 20 mg tablets
1 tablet taken orally once daily for 28 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Rate (RR) to Avatrombopag on Day 28
Platelet counts were measured from the participant's blood, which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Day 28. The RR was defined as the percentage of participants with a Day 1 platelet count of less than 30,000/milliliter (mL) who reached a platelet count of greater than or equal to 50,000/mL on Day 28 of study medication, together with the percentage of participants using steroids who had a Day 1 platelet count greater than or equal to 30,000/mL but less than 50,000/mL who reached a platelet count of greater than or equal to 20,000/mL higher than their Day 1 platelet count on Day 28 of study medication. The RR was summarized by treatment group using the method of last observation carried forward (LOCF).
Measured: Day-4 to Day 1, Baseline, Day 28
Secondary outcomes (5)
Change in Platelet Count From Baseline
Platelet counts were measured from the participant's, blood which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, 21, and 28. The unit of measure was "K/mm^3", where "K = platelets x 1000 = platelets x 10^3" and "mm^3 = cubic milliliter= microliter".
Measured: Day -4 to Day 1, Baseline, Day 7, Day 14, Day 21, Day 28
Responder Rate to Avatrombopag by Visit
Platelet counts were measured from the participant's blood, which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, and 21. The RR was summarized by treatment group using the method of LOCF. Day 28 was not included with this data because it was reported as a primary outcome measure.
Measured: Day -4 to Day 1, Baseline, Day 7, Day 14, and Day 21
Percentage of Participants With Platelet Counts Greater Than or Equal to 50,000/mL by Visit
Platelet counts were measured from the participant's blood, which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, 21, and 28.
Measured: Day -4 to Day 1, Baseline, Day 7, Day 14, Day 21, and Day 28
Percentage of Participants With Platelet Counts Greater Than or Equal to 100,000/mL by Visit
Platelet counts were measured from the participant's, blood which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, 21, and 28.
Measured: Day -4 to Day 1, Baseline, Day 7, Day 14, Day 21, and Day 28
Percentage of Participants Whose Platelet Counts Doubled From Baseline by Visit
Platelet counts were measured from the participant's, blood which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, 21, and 28.
Measured: Day -4 to Day 1, Baseline, Day 7, Day 14, Day 21, and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionJan 2009
- Study completionJun 2009
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 Chronic Idiopathic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pei-Ran Ho, MD, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441090
- Sponsor's protocol ID
- AKR-501-CL-003
- Status last verified
- Feb 2018
- First submitted
- 27 Feb 2007
- Last updated
- 7 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bussel JB, Kuter DJ, Aledort LM, Kessler CM, Cuker A, Pendergrass KB, Tang S, McIntosh J. A randomized trial of avatrombopag, an investigational thrombopoietin-receptor agonist, in persistent and chronic immune thrombocytopenia. Blood. 2014 Jun 19;123(25):3887-94. doi: 10.1182/blood-2013-07-514398. Epub 2014 May 6.
PubMed 24802775
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled, Parallel Group Study of AKR-501 Tablets Taken Orally Once Daily for 28 Days in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP).
- ClinicalTrials.gov ID
- NCT00441090
- Acronym / sponsor ID
- AKR-501-CL-003
- Keywords
- Chronic Idiopathic Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura, ITP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 28 Feb 2007 (estimated)
- Results
- Posted 4 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy, safety and tolerability, of AKR-501 (avatrombopag) tablets, as compared to placebo, in the treatment of participants with chronic Idiopathic Thrombocytopenic Purpura (ITP).
Detailed description
This is a Phase 2, multi-center, double-blind, randomized, placebo-controlled, dose-ranging, parallel-group study. The pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) relationship of avatrombopag will also be studied. Approximately 65 eligible participants will be randomized in a 3:3:3:3:1 ratio in a double-blinded fashion into one of five parallel treatment groups to receive daily doses of either avatrombopag 2.5, 5, 10 or 20 mg or placebo for 28 days, respectively. Each avatrombopag dosing group will consist of 15 participants while the placebo group will consist of 5 participants. All study participants will be evaluated weekly (Days 3, 5, 7, 14, 21 and 28) for safety, efficacy, and (Days 7, 14, 21, and 28) avatrombopag PK while receiving study treatment with a final assessment for safety and effectiveness to be done 2 weeks after the last study dose (Day 42).
At the completion of Visit Day 28±1, participants who complete 28±1 days of study dosing will be assessed for eligibility to enroll into the rollover Study 501-CL-004 (NCT00625443) based on this visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avatrombopag tablets | Experimental | Drug: Avatrombopag tablets2.5, 5, 10 or 20 mg tablets 1 tablet taken orally once daily for 28 days |
| Placebo tablet | Placebo comparator | Drug: Placebo2.5, 5, 10, or 20 mg tablets 1 tablet taken orally once daily for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Men and women ≥ 18 years of age.
- Confirmed diagnosis of ITP according to American Society of Hematology (ASH) Guidelines ≥ 3 months prior to Day 1.
- If ≥ 60 years old, must have had either a bone marrow biopsy consistent with ITP within past 3 years or a good response (platelet count > 100,000/mm^3) to a previous ITP treatment.
- Are refractory or relapsed after at least one prior ITP therapy (patients who are refractory and failed to achieve a platelet count ≥ 50,000/mm^3 despite steroids or ≥ 30,000/mm^3 to other prior ITP therapies, such as splenectomy, danazol, or immunosuppressive drugs. For patients who are relapsed, the platelet counts must be below 50,000/mm^3 if using steroids or 30,000/mm^3 if not prescribed steroids.)
- Patients receiving maintenance corticosteroids may be enrolled, as long as the corticosteroids have been administered at a stable dose (same milligram amount ± 10%) for ≥ 2 weeks prior to Screening Visit A and the investigator does not foresee the need to change the steroid dose during study participation. Patients should remain on this stable corticosteroid dose during study participation.
Key exclusion criteria (30 listed)
- Women who are pregnant and/or lactating.
- Splenectomy procedure performed 4 weeks prior to AKR-501 administration.
- Use of the following drugs or treatments prior to Day 1:
- Participation in a clinical trial involving any investigational agent within 4 weeks of Day 1.
- Exposure to eltrombopag or AMG -531.
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 |
|---|---|---|
| PlaceboPlacebo tablets 2.5, 5, 10 and 20 mg taken orally once daily for 28 days. | Drug | Placebo tablet |
| Avatrombopag tabletsAlso: AKR-501, E5501, YM477Avatrombopag tablets 2.5, 5, 10 and 20 mg taken orally once daily for 28 days. | Drug | Avatrombopag tablets |
Primary outcome
Responder Rate (RR) to Avatrombopag on Day 28
Time frame: Day-4 to Day 1, Baseline, Day 28
Platelet counts were measured from the participant's blood, which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Day 28. The RR was defined as the percentage of participants with a Day 1 platelet count of less than 30,000/milliliter (mL) who reached a platelet count of greater than or equal to 50,000/mL on Day 28 of study medication, together with the percentage of participants using steroids who had a Day 1 platelet count greater than or equal to 30,000/mL but less than 50,000/mL who reached a platelet count of greater than or equal to 20,000/mL higher than their Day 1 platelet count on Day 28 of study medication. The RR was summarized by treatment group using the method of last observation carried forward (LOCF).
5 secondary outcomes
Change in Platelet Count From Baseline
Time frame: Day -4 to Day 1, Baseline, Day 7, Day 14, Day 21, Day 28
Responder Rate to Avatrombopag by Visit
Time frame: Day -4 to Day 1, Baseline, Day 7, Day 14, and Day 21
Percentage of Participants With Platelet Counts Greater Than or Equal to 50,000/mL by Visit
Time frame: Day -4 to Day 1, Baseline, Day 7, Day 14, Day 21, and Day 28
Percentage of Participants With Platelet Counts Greater Than or Equal to 100,000/mL by Visit
Time frame: Day -4 to Day 1, Baseline, Day 7, Day 14, Day 21, and Day 28
Percentage of Participants Whose Platelet Counts Doubled From Baseline by Visit
Time frame: Day -4 to Day 1, Baseline, Day 7, Day 14, Day 21, and Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24802775Bussel JB, Kuter DJ, Aledort LM, Kessler CM, Cuker A, Pendergrass KB, Tang S, McIntosh J. A randomized trial of avatrombopag, an investigational thrombopoietin-receptor agonist, in persistent and chronic immune thrombocytopenia. Blood. 2014 Jun 19;123(25):3887-94. doi: 10.1182/blood-2013-07-514398. Epub 2014 May 6.
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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.
Pei-Ran Ho, MD study director
Eisai Inc.
25 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 tablets in people with Chronic Idiopathic Thrombocytopenic Purpura and Purpura, Thrombocytopenic, Idiopathic, run by Eisai Inc. at 25 sites in United States.
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 12 inclusion and 30 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 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. 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 4 Jan 2018). 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?
Responder Rate (RR) to Avatrombopag on Day 28 (time frame: Day-4 to Day 1, Baseline, Day 28). 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 NCT00441090, 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 7 Mar 2018.