ThrombocytopeniaPhase 3NCT03326843
Avatrombopag for the Treatment of Thrombocytopenia in Adults Scheduled for a Surgical Procedure
A Phase 3 study testing Avatrombopag 60 mg in people with Thrombocytopenia, run by Sobi, Inc. at 27 sites in United States.
Trial summary
Phase 3b open-label, multicenter study to evaluate the safety and efficacy of avatrombopag in subjects with thrombocytopenia scheduled for operations to critical sites or operations with a high risk of bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia
- What is being tested?
- Avatrombopag 60 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 27 sitesUnited States
- Study dates
- 26 Mar 2018to 25 Feb 2019
- Phase
- Phase 3
- 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 greater than or equal to 18 years of age;
- A mean baseline platelet count between:
- 50 × 10^9/L and <100 × 10^9/L for non-chronic liver disease participants
- 50 × 10^9/L and <75 × 10^9/L for participants with chronic liver disease;
- Participant is scheduled to undergo operations to critical sites (eg, eye surgery, neurosurgery) or operations with a high risk of bleeding (eg, major abdominal surgery), or, in the opinion of the Investigator, would otherwise require a pre-operative platelet transfusion to prevent bleeding
Who cannot join
- Participant with a history of arterial or venous thrombosis within 6 months of baseline;
- Participant with known portal vein blood flow velocity rate <10 cm/second or previous portal vein thrombosis within 6 months of baseline;
- Participant plans to have a platelet transfusion or plans to receive blood products containing platelets within 7 days of the Baseline Visit;
- Use of erythropoietin-stimulating agents;
- Participant has a known medical history of genetic prothrombotic syndromes; or
- Participant has abnormal hemoglobin levels or prothrombin time/international normalized ratio
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Dova Site
Aurora, Colorado, 80045
Dova Site
Austin, Texas, 78731
Dova Site
Baltimore, Maryland, 21202
Dova Site
Bethlehem, Pennsylvania, 18015
Dova Site
Boston, Massachusetts, 02115
Dova Site
Buffalo, New York, 14203
Dova Site
Coronado, California, 92118
Dova Site
Detroit, Michigan, 48202
Dova Site
Durham, North Carolina, 27710
Dova Site
Englewood, New Jersey, 07631
Dova Site
Jacksonville, Florida, 32209
Dova Site
Jacksonville, Florida, 32224
Dova Site
Little Rock, Arkansas, 72205
Dova Site
Miami, Florida, 33135
Dova Site
Miami, Florida, 33136
Dova Site
Milwaukee, Wisconsin, 53226
Dova Site
New Orleans, Louisiana, 70112
Dova Site
Newport News, Virginia, 23602
Dova Site
Pensacola, Florida, 32503
Dova Site
Reno, Nevada, 89503
Dova Site
Sarasota, Florida, 34232
Dova Site
Springfield, Missouri, 65807
Dova Site
St Louis, Missouri, 63110
Dova Site
Tamarac, Florida, 33321
Dova Site
Tampa, Florida, 33615
Dova Site
Toledo, Ohio, 43606
Dova Site
Winston-Salem, North Carolina, 27157
About this study
Official title: An Open-Label Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Subjects With Thrombocytopenia Scheduled for a Surgical Procedure
Phase 3b open-label, multicenter study to evaluate the safety and efficacy of avatrombopag in subjects with thrombocytopenia scheduled for operations to critical sites or operations with a high risk of bleeding.
Read the detailed description
Subjects will receive oral avatrombopag once daily for 5 days beginning on Day 1, followed by a wait period prior to the procedure, which will occur on Day 10 to 13. The Follow-up Period will include 2 visits; 7 days post-procedure and 30 days after last dose.
- Conditions
- Thrombocytopenia
- Being tested
- Avatrombopag 60 mg
- Keywords
- low platelet count, ITP
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avatrombopag 60 mgDrug
Oral avatrombopag administered once daily for 5 days prior to procedure.
| Study group | Role | What they receive |
|---|---|---|
| Avatrombopag 60 mg | Experimental | Open-label: oral avatrombopag Receives: Drug: Avatrombopag 60 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Efficacy of Avatrombopag in Increasing Platelet Counts in Subjects With Thrombocytopenia Scheduled for Operations
Proportion of subjects that achieve a platelet count >100 x 10^9 platelets/L on procedure day
Measured: Baseline to 10-13 days
Secondary outcomes (1)
Evaluate Safety of Avatrombopag: Incidence of Treatment Emergent Adverse Events
Incidence of treatment emergent adverse events
Measured: Up to 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start26 Mar 2018
- Primary completion25 Feb 2019
- Study completion25 Feb 2019
Why it stopped: Study was terminated due to enrollment challenges.
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.
- Other trials for ThrombocytopeniaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sobi, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326843
- Sponsor's protocol ID
- AVA-PST-320
- Status last verified
- May 2018
- First submitted
- 27 Oct 2017
- Last updated
- 15 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Subjects With Thrombocytopenia Scheduled for a Surgical Procedure
- ClinicalTrials.gov ID
- NCT03326843
- Acronym / sponsor ID
- AVA-PST-320
- Conditions
- Thrombocytopenia
- Keywords
- low platelet count, ITP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to enrollment challenges.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Sobi, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 25 Feb 2019 (actual)
- Study completion
- 25 Feb 2019 (actual)
- First posted
- 31 Oct 2017 (actual)
- Results
- Posted 15 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 3b open-label, multicenter study to evaluate the safety and efficacy of avatrombopag in subjects with thrombocytopenia scheduled for operations to critical sites or operations with a high risk of bleeding.
Detailed description
Subjects will receive oral avatrombopag once daily for 5 days beginning on Day 1, followed by a wait period prior to the procedure, which will occur on Day 10 to 13. The Follow-up Period will include 2 visits; 7 days post-procedure and 30 days after last dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avatrombopag 60 mg | Experimental | Drug: Avatrombopag 60 mgOpen-label: oral avatrombopag |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women greater than or equal to 18 years of age;
- A mean baseline platelet count between:
- Participant is scheduled to undergo operations to critical sites (eg, eye surgery, neurosurgery) or operations with a high risk of bleeding (eg, major abdominal surgery), or, in the opinion of the Investigator, would otherwise require a pre-operative platelet transfusion to prevent bleeding
Key exclusion criteria (6 listed)
- Participant with a history of arterial or venous thrombosis within 6 months of baseline;
- Participant with known portal vein blood flow velocity rate <10 cm/second or previous portal vein thrombosis within 6 months of baseline;
- Participant plans to have a platelet transfusion or plans to receive blood products containing platelets within 7 days of the Baseline Visit;
- Use of erythropoietin-stimulating agents;
- Participant has a known medical history of genetic prothrombotic syndromes; or
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 |
|---|---|---|
| Avatrombopag 60 mgOral avatrombopag administered once daily for 5 days prior to procedure. | Drug | Avatrombopag 60 mg |
Primary outcome
Evaluate Efficacy of Avatrombopag in Increasing Platelet Counts in Subjects With Thrombocytopenia Scheduled for Operations
Time frame: Baseline to 10-13 days
Proportion of subjects that achieve a platelet count >100 x 10^9 platelets/L on procedure day
1 secondary outcome
Evaluate Safety of Avatrombopag: Incidence of Treatment Emergent Adverse Events
Time frame: Up to 35 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Avatrombopag 60 mg in people with Thrombocytopenia, run by Sobi, Inc. at 27 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 5 inclusion and 6 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 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 15 Apr 2020). 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?
Evaluate Efficacy of Avatrombopag in Increasing Platelet Counts in Subjects With Thrombocytopenia Scheduled for Operations (time frame: Baseline to 10-13 days). 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 15 Apr 2020.