Platelet DisorderPhase 2NCT05143892
Avatrombopag to Promote Platelet Engraftment After Allo-HSCT
A Phase 2 study testing Avatrombopag and Supportive care in people with Platelet Disorder, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of avatrombopag for the promotion of platelet engraftment after Allo-HSCT. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Platelet Disorder
- What is being tested?
- Avatrombopag and Supportive care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 30 Nov 2023
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female, aged between 18-60 years;
- PLT<20×10^9/L after 14 days of allo-HSCT;
- Expected survival time > 3 months;
- ECOG performance status 0-2;
- Agree to receive the treatment of avatrombopag after Allo-HSCT and must sign the informed consent form.
Who cannot join
- Pregnant or lactating;
- With severe and uncontrollable infection;
- With graft-versus-host disease (GVHD) with steroid resistance;
- With thrombotic microangiopathy; With active thromboembolism requiring anticoagulation
- With detected disease recurrence due to chimerism by flow cytometry;
- With chronic active hepatitis B and C virus infection;
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- With secondary or multiple transplantation, or multiple organ transplantation;
- With severe heart disease, lung disease, diabetes and metabolic diseases;
- HIV positive;
- With a history of PLT dysfunction or bleeding disorders
- With the active hepatic venous occlusion disease, or a history of clinically significant hepatic venous occlusion disease (The disease was defined as the abnormal condition of painful hepatomegaly after transplantation with bilirubin ≥ 6.0 mg/dL);
- With progressive solid tumor;
- With severe bleeding requiring transfusion of more than 2 units of red blood cells, or sudden drop of blood cell volume ≥10% within 7 days prior to screening;
- With any other clinical trial of investigational product or device within 30 days prior to the baseline visit, except for observational study;
- With treatment of thrombopoietin receptor agonist (TPO-RA) one month before enrollment;
- Deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of Soochow University
Suzhou, Jiangsu, 215000
Meng Zhou, MD, +8615606133002, zhoumeng@suda.edu.cn
About this study
Official title: Study on Avatrombopag for the Promotion of Platelet Engraftment After Allogeneic Hematopoietic Stem Cell Transplantation
The purpose of the study is to evaluate the efficacy and safety of avatrombopag for the promotion of platelet engraftment after Allo-HSCT.
Read the detailed description
Patients with thrombocytopenia (PLT<20×10^9/L) after allogenic hematopoietic stem cell transplantation (Allo-HSCT) who meet Eligibility Criteria were assigned into the avatrombopag group for 4 weeks' treatment.
- Conditions
- Platelet Disorder
- Being tested
- Avatrombopag, Supportive care
- Keywords
- Avatrombopag, thrombocytopenia, allogenic hematopoietic stem cell transplantation, engraftment
- Medical subject headings
- Blood Platelet Disorders, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvatrombopagDrug
Also called Doptelet
Avatrombopag administered at the described frequency to achieve a target platelet count
Supportive careOther
Also called support
Supportive care other than TPO-RAs or recombinant human thrombopoietin.
| Study group | Role | What they receive |
|---|---|---|
| Avatrombopag | Experimental | In the 4-weeks'study,the initial dose of avatrombopag is 20 mg/d. If the patient's PLT count remains less than 20*10^9/L after one week, the maximum dose was increased to 40 mg/d. Avatrombopag will be taken orally with food. Receives: Drug: Avatrombopag |
| Supportive care | Other | Patients in this arm receive same treatment as in the avatrombopag group,except any TPO-RAs or recombinant human thrombopoietin. Receives: Other: Supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants whose PLT reaches ≥ 20*10^9/L without the need for PLT transfusion.
Accumulated platelet engraftment ratio
Measured: up to 4 weeks
Secondary outcomes (4)
Percentage of participants whose PLT reaches ≥ 50*10^9/L without the need for PLT transfusion.
Accumulated complete platelet engraftment ratio
Measured: up to 4 weeks
The time to achieve PLT ≥ 20*10^9/L without the need of PLT transfusion for consecutive 7 days (Defined as the first day when PLT ≥ 20×10^9/L without relying on platelet transfusion for 7 consecutive days )
time duration of platelet engraftment
Measured: up to 4 weeks
Volume of PLT transfusion
Volume of PLT transfusion
Measured: up to 4 weeks
Hematopoietic reconstruction condition
absolute neutrophils, hemoglobin
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Dec 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Platelet DisorderStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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
- Model description
- Patients will be randomized into avatrombopag group or supportive care group at the ratio of 1:1.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HAN Yue, The First Affiliated Hospital of Soochow University
- Investigators
- Yue Han, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143892
- Sponsor's protocol ID
- SOOCHOW-HY-2021-11
- Status last verified
- Dec 2022
- First submitted
- 21 Nov 2021
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou M, Qi J, Gu C, Wang H, Zhang Z, Wu D, Han Y. Avatrombopag for the treatment of thrombocytopenia post hematopoietic stem-cell transplantation. Ther Adv Hematol. 2022 Sep 28;13:20406207221127532. doi: 10.1177/20406207221127532. eCollection 2022.
PubMed 36185780
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Avatrombopag for the Promotion of Platelet Engraftment After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT05143892
- Acronym / sponsor ID
- SOOCHOW-HY-2021-11
- Conditions
- Platelet Disorder
- Keywords
- Avatrombopag, thrombocytopenia, allogenic hematopoietic stem cell transplantation, engraftment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 3 Dec 2021 (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.
The purpose of the study is to evaluate the efficacy and safety of avatrombopag for the promotion of platelet engraftment after Allo-HSCT.
Detailed description
Patients with thrombocytopenia (PLT<20×10^9/L) after allogenic hematopoietic stem cell transplantation (Allo-HSCT) who meet Eligibility Criteria were assigned into the avatrombopag group for 4 weeks' treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized into avatrombopag group or supportive care group at the ratio of 1:1.
| Arm | Type | Receives |
|---|---|---|
| Avatrombopag | Experimental | Drug: AvatrombopagIn the 4-weeks'study,the initial dose of avatrombopag is 20 mg/d. If the patient's PLT count remains less than 20*10^9/L after one week, the maximum dose was increased to 40 mg/d. Avatrombopag will be taken orally with food. |
| Supportive care | Other | Other: Supportive carePatients in this arm receive same treatment as in the avatrombopag group,except any TPO-RAs or recombinant human thrombopoietin. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female, aged between 18-60 years;
- PLT<20×10^9/L after 14 days of allo-HSCT;
- Expected survival time > 3 months;
- ECOG performance status 0-2;
- Agree to receive the treatment of avatrombopag after Allo-HSCT and must sign the informed consent form.
Key exclusion criteria (16 listed)
- Pregnant or lactating;
- With severe and uncontrollable infection;
- With graft-versus-host disease (GVHD) with steroid resistance;
- With thrombotic microangiopathy; With active thromboembolism requiring anticoagulation
- With detected disease recurrence due to chimerism by flow cytometry;
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 |
|---|---|---|
| AvatrombopagAlso: DopteletAvatrombopag administered at the described frequency to achieve a target platelet count | Drug | Avatrombopag |
| Supportive careAlso: supportSupportive care other than TPO-RAs or recombinant human thrombopoietin. | Other | Supportive care |
Primary outcome
Percentage of participants whose PLT reaches ≥ 20*10^9/L without the need for PLT transfusion.
Time frame: up to 4 weeks
Accumulated platelet engraftment ratio
4 secondary outcomes
Percentage of participants whose PLT reaches ≥ 50*10^9/L without the need for PLT transfusion.
Time frame: up to 4 weeks
The time to achieve PLT ≥ 20*10^9/L without the need of PLT transfusion for consecutive 7 days (Defined as the first day when PLT ≥ 20×10^9/L without relying on platelet transfusion for 7 consecutive days )
Time frame: up to 4 weeks
Volume of PLT transfusion
Time frame: up to 4 weeks
Hematopoietic reconstruction condition
Time frame: up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Background: PubMed 36185780Zhou M, Qi J, Gu C, Wang H, Zhang Z, Wu D, Han Y. Avatrombopag for the treatment of thrombocytopenia post hematopoietic stem-cell transplantation. Ther Adv Hematol. 2022 Sep 28;13:20406207221127532. doi: 10.1177/20406207221127532. eCollection 2022.
- 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.
Yue Han principal investigator
The First Affiliated Hospital of Soochow University
1 site 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 and Supportive care in people with Platelet Disorder, run by The First Affiliated Hospital of Soochow University at 1 site in China.
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 16 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: status not confirmed, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yue Han, MD PhD ((0086)51267781856, hanyue@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants whose PLT reaches ≥ 20*10^9/L without the need for PLT transfusion. (time frame: up to 4 weeks). 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 NCT05143892, 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 23 Dec 2022.