ThrombocytopeniaNCT03554759
Avatrombopag for the Treatment of Thrombocytopenia in Adults With Chronic Liver Disease Undergoing a Procedure
An observational study of Thrombocytopenia, run by Sobi, Inc. at 41 sites in United States.
Trial summary
Phase 4 observational cohort study to characterize the treatment patterns and effects of avatrombopag use in patients with thrombocytopenia associated with chronic liver disease who are either undergoing, or have already undergone, a procedure. 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
- How many people
- 50 participants
- Where
- 41 sitesUnited States
- Study dates
- 2 Jul 2018to 31 Jan 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients ≥18 years of age who have thrombocytopenia associated with chronic liver disease and are planned for or underwent treatment with avatrombopag prior to a procedure.
Who may be able to join
- Patient has thrombocytopenia associated with chronic liver disease and is planned for or underwent treatment with avatrombopag prior to a procedure
- Patient provides written informed consent
- Minimum Data for Retrospective Enrollment
- Platelet count from approximately 7 days prior to starting avatrombopag
- Platelet count on Procedure Day
Who cannot join
None listed.
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
United States41 sites
Dova Study Site
Ann Arbor, Michigan, 48109
Dova Study Site
Atlanta, Georgia, 30309
Dova Study Site
Aurora, Colorado, 80045
Dova Study Site
Baltimore, Maryland, 21202
Dova Study Site
Boston, Massachusetts, 02215
Dova Study Site
Burlington, Massachusetts, 01805
Dova Site
Chandler, Arizona, 85224
Dova Study Site
Charlottesville, Virginia, 22908
Dova Study Site
Cleveland, Ohio, 44016
Dova Study Site
Columbus, Ohio, 43210
Dova Study Site
Dallas, Texas, 75234
Dova Study Site
Detroit, Michigan, 48239
Dova Study Site
Durham, North Carolina, 27710
Dova Study Site
Englewood, Colorado, 80113
Dova Study Site
Flourtown, Pennsylvania, 19031
Dova Study Site
Gainesville, Florida, 32610
Dova Study Site
Houston, Texas, 77030
Dova Site
Jackson, Mississippi, 39216
Dova Study Site
Johnson City, Tennessee, 37604
Dova Site
Lancaster, California, 93534
Dova Study Site
Los Angeles, California, 90048
Dova Study Site
Louisville, Kentucky, 40202
Dova Study Site
Manhasset, New York, 11030
Dova Study Site
Memphis, Tennessee, 38104
Dova Study Site
Miami, Florida, 33136
Dova Study Site
Milwaukee, Wisconsin, 53226
Dova Study Site
New Brunswick, New Jersey, 08901
Dova Study Site
New York, New York, 10016
Dova Site
Palm Springs, California, 92262
Dova Study Site
Pasadena, California, 91107
Dova Site
Philadelphia, Pennsylvania, 19141
Dova Study Site
Pittsburgh, Pennsylvania, 15213
Dova Study Site
Richmond, Virginia, 23226
Dova Study SIte
Roanoke, Virginia, 24014
Dova Study Site
San Clemente, California, 92673
Dova Study Site
San Diego, California, 92114
Dova Study Site
San Diego, California, 92121
Dova Study Site
The Bronx, New York, 10467
Dova Study Site
Topeka, Kansas, 66606
Dova Study Site
Union City, Tennessee, 38261
Dova Study Site
Worcester, Massachusetts, 01655
About this study
Official title: An Observational Cohort Study of the Use of Avatrombopag in Patients With Thrombocytopenia Associated With Chronic Liver Disease Undergoing a Procedure
Phase 4 observational cohort study to characterize the treatment patterns and effects of avatrombopag use in patients with thrombocytopenia associated with chronic liver disease who are either undergoing, or have already undergone, a procedure.
Read the detailed description
Data (e.g. type of procedure, platelet count, etc.) will be collected retrospectively or prospectively from patient visits occurring within approximately 7 calendar days prior to the first dose of avatrombopag, on Procedure Day, on Discharge Day, and from any clinic visit performed up to 30 days post-procedure. All treatment decisions and clinical assessments will be at the discretion of the treating physician per routine medical care and are not mandated by study design or protocol.
- Conditions
- Thrombocytopenia
- Being tested
- Avatrombopag
- Keywords
- Chronic Liver Disease, Low Platelet Count
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvatrombopagDrug
Avatrombopag dosing will be determined by the treating physician in conjunction with the FDA-approved package insert.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in platelet count
Measured: Up to 8 days after the last dose of avatrombopag.
Secondary outcomes (2)
Proportion of patients who received a platelet transfusion
Measured: From the first dose of avatrombopag to up to 15 days after the last dose of avatrombopag
Occurrence of adverse events
Measured: From the first dose of avatrombopag to up to 30 days after the last dose of avatrombopag
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start2 Jul 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Why it stopped: Study was terminated early due to enrollment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 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
- NCT03554759
- Sponsor's protocol ID
- AVA-CLD-401
- Status last verified
- Oct 2024
- First submitted
- 22 May 2018
- Last updated
- 21 Oct 2024
- Results posted
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Cohort Study of the Use of Avatrombopag in Patients With Thrombocytopenia Associated With Chronic Liver Disease Undergoing a Procedure
- ClinicalTrials.gov ID
- NCT03554759
- Acronym / sponsor ID
- AVA-CLD-401
- Conditions
- Thrombocytopenia
- Keywords
- Chronic Liver Disease, Low Platelet Count
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was terminated early due to enrollment challenges
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sobi, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 13 Jun 2018 (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.
Phase 4 observational cohort study to characterize the treatment patterns and effects of avatrombopag use in patients with thrombocytopenia associated with chronic liver disease who are either undergoing, or have already undergone, a procedure.
Detailed description
Data (e.g. type of procedure, platelet count, etc.) will be collected retrospectively or prospectively from patient visits occurring within approximately 7 calendar days prior to the first dose of avatrombopag, on Procedure Day, on Discharge Day, and from any clinic visit performed up to 30 days post-procedure. All treatment decisions and clinical assessments will be at the discretion of the treating physician per routine medical care and are not mandated by study design or protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients ≥18 years of age who have thrombocytopenia associated with chronic liver disease and are planned for or underwent treatment with avatrombopag prior to a procedure.
Key inclusion criteria (5 listed)
- Patient has thrombocytopenia associated with chronic liver disease and is planned for or underwent treatment with avatrombopag prior to a procedure
- Patient provides written informed consent
- Minimum Data for Retrospective Enrollment
- Platelet count from approximately 7 days prior to starting avatrombopag
- Platelet count on Procedure Day
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| AvatrombopagAvatrombopag dosing will be determined by the treating physician in conjunction with the FDA-approved package insert. | Drug | – |
Primary outcome
Change in platelet count
Time frame: Up to 8 days after the last dose of avatrombopag.
2 secondary outcomes
Proportion of patients who received a platelet transfusion
Time frame: From the first dose of avatrombopag to up to 15 days after the last dose of avatrombopag
Occurrence of adverse events
Time frame: From the first dose of avatrombopag to up to 30 days after the last dose of avatrombopag
Results and safety
The study was stopped early (reason given: Study was terminated early due to enrollment challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
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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.
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenia, run by Sobi, Inc. at 41 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 0 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 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 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.
Are results available for this study?
The study was stopped early (reason given: Study was terminated early due to enrollment challenges). 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?
Change in platelet count (time frame: Up to 8 days after the last dose of avatrombopag.). 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 21 Oct 2024.