ThrombocytopeniaPhase 2NCT04896528
Efficacy and Safety of Avatrombopag in Cancer Patients With Thrombocytopenia
A Phase 2 study testing Avatrombopag in people with Thrombocytopenia and Avatrombopag, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Avatrombopag in patients with thrombocytopenia induced by targeted therapy and immunotherapy combination treatment, and provide evidence-based medication for the clinical use of Avatrombopag in patients with PC ≤50×109/L Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Thrombocytopenia, Avatrombopag
- What is being tested?
- Avatrombopag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2021to 31 Dec 2021
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each participant must meet all of the following criteria:
- Male or female, 18~85 years of age;
- Diagnosis of malignant solid tumor;
- Participants receiving combined targeted therapy (including but not limited to tyrosine kinase inhibitors, cyclin-dependent kinase inhibitors) with immunotherapy (including but not limited to PD-1 inhibitors and/or PD-L1 inhibitors and/or CTLA-4 inhibitors);
- Participants experienced grade III or above thrombocytopenia (PC ≤50×109/L) at least once within 48 h of the screening period; No oral platelet-enhancing drugs were given before enrollmen.
- ECGO performance status ≤2;
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- Blood test:
- Hemoglobin (Hb) ≥ 9.0 g/dL;
- Absolute neutrophils count (ANC) ≥ 1,500/μL;
- Liver and renal functions:
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3*ULN (Upper Limits of Normal);
- Serum bilirubin ≤ 1.5*ULN;
- Albumin ≥ 2.5 g/dL;
- Serum creatinine ≤ 1.5*ULN (CTCAE Grade Ⅰ)
- Participants able to oral medication;
- Expected survival time ≥12 weeks during screening period;
- Participants with negative urine or serum pregnancy test during screening period; fertile potential participants must agree to use contraception for the whole study period and 30 days after discontinuity of investigational product treatment (infertile potential was defined as the condition including hysterectomy and bilateral oophorectomy, bilateral salpingectomy, tubal ligation and postmenopausal);
- Participants in the trial is voluntary and must strictly abide by the protocol;
- Participants must sign the written informed consent form.
Who cannot join
- Participants meeting any of the following criteria will be excluded from the study:
- Participants has any history of active congestive heart failure [New York Heart Association (NYHA) Grade III-IV], symptomatic ischemia, uncontrolled arrhythmia, pericardial disease, or myocardial infarction during the first 4 months of enrollment;
- Participants finished major operation within less than 28 days and for minor operation within less than 3 days;
- Participants had clinically significant acute or active bleeding (e.g., gastrointestinal or central nervous system) within 7 days prior to screening;
- Participants has medical-known hereditary prethrombotic syndrome (such as factor V Leiden mutation, prothrombin G20210A mutation or hereditary antithrombin III deficiency);
- Participants has a history of arterial or venous thrombosis within 3 months prior to screening;
Show all 15Show fewer
- Participants had treatment with heparin and warfarin within 7 days prior to screening;
- Participants has history of chronic thrombocytopenia or hemorrhagic disease, or thrombocytopenia induced by other reasons besides targeted therapy and immunotherapy combination treatment(e.g., chronic liver disease or immune thrombocytopenic purpura);
- Participants had the treatment of platelet transfusion within 3 days before enrollment;
- Participants had administration of platelet growth factor (e.g., rhTPO, rhIL-11, Eltrombopag, or Romiplostim) for the treatment of thrombocytopenia induced by targeted therapy and immunotherapy combination treatment within 2 weeks prior to screening;
- Participants' thrombocytopenia responded effectively to hormone therapy;
- Participants are allergic to Avatrombopag or any of its excipients;
- Participants were in any other clinical trial of investigational product or device within 30 days prior to screening, except for observational study;
- Participants have any known concomitant history that may impair the safe completion of the study as assessed by the investigator, such as unstable angina, renal failure due to hemodialysis, or active infection requiring intravenous antibiotics;
- Participants are pregnant or lactating at the time of screening (as demonstrated by a positive serum β-HCG test) or baseline visit (positive urine β-HCG test)
Trial locations and contacts
1 site in 1 country.
Haitao Haitao, Prof contact
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yanyu Wang, MD, +86-15810784518, pumcwyy950105@163.com
Xiao-Bo Xiao-Bo, MD, +86-138-1167-5126, yangxiaobo67@pumch.cn
About this study
Official title: Efficacy and Safety of Avatrombopag in Cancer Patients With Thrombocytopenia Induced by Targeted Therapy and Immunotherapy Combination Treatment
To evaluate the efficacy and safety of Avatrombopag in patients with thrombocytopenia induced by targeted therapy and immunotherapy combination treatment, and provide evidence-based medication for the clinical use of Avatrombopag in patients with PC ≤50×109/L
Read the detailed description
This phase II trial is a single-arm, non-randomized and single-center clinical study.
It is estimated that 30 patients who met the study criteria will be enrolled in PUMCH and treated with Avatrombopag. The investigators will follow up and collect subjects' data each month to evaluate the efficacy and safety of treatment. Primary outcome measure is percentage of participants whose PLT reaches ≥75×109/L, or increases by ≥50×109/L or ≥100% from baseline at least once within 20 days of initial treatment.
Secondary outcome measure:1)Number of days required for PLT to reach ≥50×109/L after treatment; 2)Number of days required for PLT to reach ≥75×109/L after treatment; 3)Percentage of subjects without platelet transfusion within 20 days of treatment; 4)Percentage of subjects without clinically relevant bleeding within 20 days of treatment.
Study Type: Interventional. Masking: Open Label.
- Conditions
- Thrombocytopenia, Avatrombopag
- Being tested
- Avatrombopag
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvatrombopagDrug
- Participants meeting the eligibility criteria receive Avatrombopag treatment (orally, 60 mg/day), for a maximum course of 20 days.
- Investigation product withdrawal: PLT ≥75×109/L or increases by at least 50×109/L from the lowest value after targeted therapy and immunotherapy combination treatment.
| Study group | Role | What they receive |
|---|---|---|
| Avatrombopag | Experimental | Avartripopa is a new generation of oral TPO receptor agonist that simulates the biological effects of TPO in vitro and in vivo.
TPO stimulates megakaryocytes through binding and activation of TPO receptor, which is expressed in hematopoietic stem cells, megakaryotic cell lines and platelets.
By binding to the transmembrane region of the thrombopoietin receptor, Ava Tripopa activates the thrombopoietin receptor in humans, stimulates signal transduction and mimics the biological effects of thrombopoietin, leading to an increase in platelet count. Receives: Drug: Avatrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants' PLT
Percentage of participants whose PLT reaches ≥75×109/L, or increases by ≥50×109/L or ≥100% from baseline at least once within 20 days of initial treatment.
Measured: one year
Secondary outcomes (4)
Number of days required for PLT to reach ≥50×109/L after treatment;
Measured: one year
Number of days required for PLT to reach ≥75×109/L after treatment;
Measured: one year
Percentage of subjects without platelet transfusion within 20 days of treatment;
Measured: one year
Percentage of subjects without clinically relevant bleeding within 20 days of treatment.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start6 Jun 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients receiving combined targeted therapy (including but not limited to tyrosine kinase inhibitors, cyclin-dependent kinase inhibitors) with immunotherapy (including but not limited to PD-1 inhibitors and/or PD-L1 inhibitors and/or CTLA-4 inhibitors); Patients experienced grade III or above thrombocytopenia (PC ≤50×109/L) at least once within 48 h of the screening period;
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haitao Haitao, Prof, Study chair, Peking Union Medical College Hospital (PUMCH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896528
- Sponsor's protocol ID
- SKX-CIT-002
- Status last verified
- Apr 2021
- First submitted
- 28 Apr 2021
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arora S, Balasubramaniam S, Zhang W, Zhang L, Sridhara R, Spillman D, Mathai JP, Scott B, Golding SJ, Coory M, Pazdur R, Beaver JA. FDA Approval Summary: Pembrolizumab plus Lenvatinib for Endometrial Carcinoma, a Collaborative International Review under Project Orbis. Clin Cancer Res. 2020 Oct 1;26(19):5062-5067. doi: 10.1158/1078-0432.CCR-19-3979. Epub 2020 Apr 15.
PubMed 32295834Lingen MW, Kalmar JR, Karrison T, Speight PM. Critical evaluation of diagnostic aids for the detection of oral cancer. Oral Oncol. 2008 Jan;44(1):10-22. doi: 10.1016/j.oraloncology.2007.06.011. Epub 2007 Sep 6.
PubMed 17825602Adelstein DJ, Li Y, Adams GL, Wagner H Jr, Kish JA, Ensley JF, Schuller DE, Forastiere AA. An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer. J Clin Oncol. 2003 Jan 1;21(1):92-8. doi: 10.1200/JCO.2003.01.008.
PubMed 12506176Pignon JP, le Maitre A, Maillard E, Bourhis J; MACH-NC Collaborative Group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): an update on 93 randomised trials and 17,346 patients. Radiother Oncol. 2009 Jul;92(1):4-14. doi: 10.1016/j.radonc.2009.04.014. Epub 2009 May 14.
PubMed 19446902Suntharalingam M, Haas ML, Conley BA, Egorin MJ, Levy S, Sivasailam S, Herman JM, Jacobs MC, Gray WC, Ord RA, Aisner JA, Van Echo DA. The use of carboplatin and paclitaxel with daily radiotherapy in patients with locally advanced squamous cell carcinomas of the head and neck. Int J Radiat Oncol Biol Phys. 2000 Apr 1;47(1):49-56. doi: 10.1016/s0360-3016(00)00408-9.
PubMed 10758304Garden AS, Harris J, Vokes EE, Forastiere AA, Ridge JA, Jones C, Horwitz EM, Glisson BS, Nabell L, Cooper JS, Demas W, Gore E. Preliminary results of Radiation Therapy Oncology Group 97-03: a randomized phase ii trial of concurrent radiation and chemotherapy for advanced squamous cell carcinomas of the head and neck. J Clin Oncol. 2004 Jul 15;22(14):2856-64. doi: 10.1200/JCO.2004.12.012.
PubMed 15254053Adkins D, Ley J, Michel L, Wildes TM, Thorstad W, Gay HA, Daly M, Rich J, Paniello R, Uppaluri R, Jackson R, Trinkaus K, Nussenbaum B. nab-Paclitaxel, cisplatin, and 5-fluorouracil followed by concurrent cisplatin and radiation for head and neck squamous cell carcinoma. Oral Oncol. 2016 Oct;61:1-7. doi: 10.1016/j.oraloncology.2016.07.015. Epub 2016 Jul 29.
PubMed 27688097Reddy BK, Lokesh V, Vidyasagar MS, Shenoy K, Babu KG, Shenoy A, Naveen T, Joseph B, Bonanthaya R, Nanjundappa, Bapsy PP, Loknatha, Shetty J, Prasad K, Tanvir Pasha CR. Nimotuzumab provides survival benefit to patients with inoperable advanced squamous cell carcinoma of the head and neck: a randomized, open-label, phase IIb, 5-year study in Indian patients. Oral Oncol. 2014 May;50(5):498-505. doi: 10.1016/j.oraloncology.2013.11.008. Epub 2014 Mar 6.
PubMed 24613543
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Avatrombopag in Cancer Patients With Thrombocytopenia Induced by Targeted Therapy and Immunotherapy Combination Treatment
- ClinicalTrials.gov ID
- NCT04896528
- Acronym / sponsor ID
- SKX-CIT-002
- Conditions
- Thrombocytopenia, Avatrombopag
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 6 Jun 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 21 May 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.
To evaluate the efficacy and safety of Avatrombopag in patients with thrombocytopenia induced by targeted therapy and immunotherapy combination treatment, and provide evidence-based medication for the clinical use of Avatrombopag in patients with PC ≤50×109/L
Detailed description
This phase II trial is a single-arm, non-randomized and single-center clinical study.
It is estimated that 30 patients who met the study criteria will be enrolled in PUMCH and treated with Avatrombopag. The investigators will follow up and collect subjects' data each month to evaluate the efficacy and safety of treatment. Primary outcome measure is percentage of participants whose PLT reaches ≥75×109/L, or increases by ≥50×109/L or ≥100% from baseline at least once within 20 days of initial treatment.
Secondary outcome measure:1)Number of days required for PLT to reach ≥50×109/L after treatment; 2)Number of days required for PLT to reach ≥75×109/L after treatment; 3)Percentage of subjects without platelet transfusion within 20 days of treatment; 4)Percentage of subjects without clinically relevant bleeding within 20 days of treatment.
Study Type: Interventional. Masking: Open Label.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients receiving combined targeted therapy (including but not limited to tyrosine kinase inhibitors, cyclin-dependent kinase inhibitors) with immunotherapy (including but not limited to PD-1 inhibitors and/or PD-L1 inhibitors and/or CTLA-4 inhibitors); Patients experienced grade III or above thrombocytopenia (PC ≤50×109/L) at least once within 48 h of the screening period;
| Arm | Type | Receives |
|---|---|---|
| Avatrombopag | Experimental | Drug: AvatrombopagAvartripopa is a new generation of oral TPO receptor agonist that simulates the biological effects of TPO in vitro and in vivo. TPO stimulates megakaryocytes through binding and activation of TPO receptor, which is expressed in hematopoietic stem cells, megakaryotic cell lines and platelets. By binding to the transmembrane region of the thrombopoietin receptor, Ava Tripopa activates the thrombopoietin receptor in humans, stimulates signal transduction and mimics the biological effects of thrombopoietin, leading to an increase in platelet count. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male or female, 18~85 years of age;
- Diagnosis of malignant solid tumor;
- Participants receiving combined targeted therapy (including but not limited to tyrosine kinase inhibitors, cyclin-dependent kinase inhibitors) with immunotherapy (including but not limited to PD-1 inhibitors and/or PD-L1 inhibitors and/or CTLA-4 inhibitors);
- Participants experienced grade III or above thrombocytopenia (PC ≤50×109/L) at least once within 48 h of the screening period; No oral platelet-enhancing drugs were given before enrollmen.
- ECGO performance status ≤2;
Key exclusion criteria (15 listed)
- Participants has any history of active congestive heart failure [New York Heart Association (NYHA) Grade III-IV], symptomatic ischemia, uncontrolled arrhythmia, pericardial disease, or myocardial infarction during the first 4 months of enrollment;
- Participants finished major operation within less than 28 days and for minor operation within less than 3 days;
- Participants had clinically significant acute or active bleeding (e.g., gastrointestinal or central nervous system) within 7 days prior to screening;
- Participants has medical-known hereditary prethrombotic syndrome (such as factor V Leiden mutation, prothrombin G20210A mutation or hereditary antithrombin III deficiency);
- Participants has a history of arterial or venous thrombosis within 3 months prior to screening;
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* Participants meeting the eligibility criteria receive Avatrombopag treatment (orally, 60 mg/day), for a maximum course of 20 days. * Investigation product withdrawal: PLT ≥75×109/L or increases by at least 50×109/L from the lowest value after targeted therapy and immunotherapy combination treatment. | Drug | Avatrombopag |
Primary outcome
Percentage of participants' PLT
Time frame: one year
Percentage of participants whose PLT reaches ≥75×109/L, or increases by ≥50×109/L or ≥100% from baseline at least once within 20 days of initial treatment.
4 secondary outcomes
Number of days required for PLT to reach ≥50×109/L after treatment;
Time frame: one year
Number of days required for PLT to reach ≥75×109/L after treatment;
Time frame: one year
Percentage of subjects without platelet transfusion within 20 days of treatment;
Time frame: one year
Percentage of subjects without clinically relevant bleeding within 20 days of treatment.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Background: PubMed 32295834Arora S, Balasubramaniam S, Zhang W, Zhang L, Sridhara R, Spillman D, Mathai JP, Scott B, Golding SJ, Coory M, Pazdur R, Beaver JA. FDA Approval Summary: Pembrolizumab plus Lenvatinib for Endometrial Carcinoma, a Collaborative International Review under Project Orbis. Clin Cancer Res. 2020 Oct 1;26(19):5062-5067. doi: 10.1158/1078-0432.CCR-19-3979. Epub 2020 Apr 15.
- Results publication: PubMed 17825602Lingen MW, Kalmar JR, Karrison T, Speight PM. Critical evaluation of diagnostic aids for the detection of oral cancer. Oral Oncol. 2008 Jan;44(1):10-22. doi: 10.1016/j.oraloncology.2007.06.011. Epub 2007 Sep 6.
- Results publication: PubMed 12506176Adelstein DJ, Li Y, Adams GL, Wagner H Jr, Kish JA, Ensley JF, Schuller DE, Forastiere AA. An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer. J Clin Oncol. 2003 Jan 1;21(1):92-8. doi: 10.1200/JCO.2003.01.008.
- Results publication: PubMed 19446902Pignon JP, le Maitre A, Maillard E, Bourhis J; MACH-NC Collaborative Group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): an update on 93 randomised trials and 17,346 patients. Radiother Oncol. 2009 Jul;92(1):4-14. doi: 10.1016/j.radonc.2009.04.014. Epub 2009 May 14.
- Results publication: PubMed 10758304Suntharalingam M, Haas ML, Conley BA, Egorin MJ, Levy S, Sivasailam S, Herman JM, Jacobs MC, Gray WC, Ord RA, Aisner JA, Van Echo DA. The use of carboplatin and paclitaxel with daily radiotherapy in patients with locally advanced squamous cell carcinomas of the head and neck. Int J Radiat Oncol Biol Phys. 2000 Apr 1;47(1):49-56. doi: 10.1016/s0360-3016(00)00408-9.
- Results publication: PubMed 15254053Garden AS, Harris J, Vokes EE, Forastiere AA, Ridge JA, Jones C, Horwitz EM, Glisson BS, Nabell L, Cooper JS, Demas W, Gore E. Preliminary results of Radiation Therapy Oncology Group 97-03: a randomized phase ii trial of concurrent radiation and chemotherapy for advanced squamous cell carcinomas of the head and neck. J Clin Oncol. 2004 Jul 15;22(14):2856-64. doi: 10.1200/JCO.2004.12.012.
- Results publication: PubMed 27688097Adkins D, Ley J, Michel L, Wildes TM, Thorstad W, Gay HA, Daly M, Rich J, Paniello R, Uppaluri R, Jackson R, Trinkaus K, Nussenbaum B. nab-Paclitaxel, cisplatin, and 5-fluorouracil followed by concurrent cisplatin and radiation for head and neck squamous cell carcinoma. Oral Oncol. 2016 Oct;61:1-7. doi: 10.1016/j.oraloncology.2016.07.015. Epub 2016 Jul 29.
- Results publication: PubMed 24613543Reddy BK, Lokesh V, Vidyasagar MS, Shenoy K, Babu KG, Shenoy A, Naveen T, Joseph B, Bonanthaya R, Nanjundappa, Bapsy PP, Loknatha, Shetty J, Prasad K, Tanvir Pasha CR. Nimotuzumab provides survival benefit to patients with inoperable advanced squamous cell carcinoma of the head and neck: a randomized, open-label, phase IIb, 5-year study in Indian patients. Oral Oncol. 2014 May;50(5):498-505. doi: 10.1016/j.oraloncology.2013.11.008. Epub 2014 Mar 6.
- 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.
Haitao Haitao, Prof contact
Haitao Haitao, Prof study chair
Peking Union Medical College Hospital (PUMCH)
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 in people with Thrombocytopenia and Avatrombopag, run by Peking Union Medical College Hospital 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 19 inclusion and 15 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 21 May 2021. 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 Yanyu Wang, MD (+86 15810784518, pumcwyy950105@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants' PLT (time frame: one year). 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 NCT04896528, which also lists 8 linked publications.
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 May 2021.