Non-severe Aplastic AnemiaPhase 2NCT05797623
Safety and Effectiveness of Trappa Ethanolamine Tablets Combined With Ciclosporin in the Treatment of Primary Treatment of Non-severe Aplastic Anemia
A Phase 2 study testing Trappa ethanolamine tablets ; ciclosporin in people with Non-severe Aplastic Anemia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, and open-label, placebo-controlled phase II clinical study. In order to evaluate the effectiveness and safety of trappa ethanolamine tablets combined with ciclosporin in the treatment of patients with non-severe aplastic anemia. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Non-severe Aplastic Anemia
- What is being tested?
- Trappa ethanolamine tablets ; ciclosporin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 26 Apr 2023to 30 May 2025
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 14-75 years old (including boundary value, whichever is at the time of signing the informed consent form), Gender is not limited.
- Diagnosed with non-heavy aplastic anemia within 6 months
- Life Functional Status (ECOG) Score 0-1
- Those who understand the research procedures and methods, voluntarily participate in this experiment, and sign the informed consent form in writing
Who cannot join
- Total blood cell loss and myelohypoproliferative diseases caused by other reasons
- Chromosome karyotype analysis during screening shows clonal cytogenetic abnormalities
- Meet the severe aplastic anemia
- Paroxysmal sleep hemoglobinuria (PNH) clone ≥50% or hemolytic PNH clone
- Randomly receive ATG, ciclosporin, TPO-R agonists, androgens and other drugs to treat the relapse without completing the elution
- Pre-randomized treatment with erythropoietin
Show all 20Show fewer
- Pre-randomized use of corticosteroids, G-CSF and GM-CSF treatment
- People with a history of hematopoietic stem cell transplantation
- subjects who had deep vein thrombosis, myocardial infarction, cerebral infarction or peripheral arterial embolism in the first 12 months
- Previous history of liver cirrhosis or portal hypertension
- When screening, alanine aminotransferase, barley transaminase, total bilirubin and blood creatinine are higher than the upper limit of normal value
- HIV infection or carrier in the past or screening; hepatitis C antibody positive; hepatitis B surface antigen positive or hepatitis B core antibody positive, and HBV-DNA test indicates virus replication
- Patients with randomized bleeding and/or infection that are still uncontrollable after standardized treatment
- Uncontrolled hypertension at screening, severe arrhythmia, level III/IV (graded by the New York Heart Association) congestive heart failure
- Those who are known or suspected to be contraindicated or highly sensitive to Trappa ethanolamine API or cyclosporine
- The subjects had any malignant solid tumors of the organ system in the first 5 years of screening, regardless of whether they had been treated, metastasis or relapsed, except for local skin basal cell carcinoma; subjects with blood tumors found in the past or screening
- Pregnant or lactating women
- Male subjects of women of childbearing age or partners of women of childbearing age refuse to use acceptable contraceptive measures from the period of taking the drug to 28 days after the last time of taking the drug.
- Randomly participated in other clinical trials and took research drugs in the first 3 months.
- The researchers believe that there is any situation that may cause the subject to be unable to complete the study or pose an obvious risk to the subject, or other factors that reduce the possibility of joining the group.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 30000
Fengkui Zhang
About this study
Official title: A Multicenter, Randomized, Double-blind, and Open-label, Placebo-controlled Phase II Clinical Study of Trappa Ethanolamine Tablets Combined With Ciclosporin in Patients With Treatment of Non-severe Aplastic Anemia
This is a multicenter, randomized, double-blind, and open-label, placebo-controlled phase II clinical study. In order to evaluate the effectiveness and safety of trappa ethanolamine tablets combined with ciclosporin in the treatment of patients with non-severe aplastic anemia.
- Conditions
- Non-severe Aplastic Anemia
- Being tested
- Trappa ethanolamine tablets ; ciclosporin, Placebo ; ciclosporin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trappa ethanolamine tablets ; ciclosporinDrug
Trappa ethanolamine tablets combined with ciclosporin
Placebo ; ciclosporinDrug
Placebo combined with ciclosporin
| Study group | Role | What they receive |
|---|---|---|
| Trappa ethanolamine tablets combined with ciclosporin | Experimental | Not described Receives: Drug: Trappa ethanolamine tablets ; ciclosporin |
| Placebo combined with ciclosporin | Placebo comparator | Not described Receives: Drug: Placebo ; ciclosporin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full hematological response rate
Measured: About 13 weeks from the first medication to the evaluation.
Secondary outcomes (11)
Partial hematological response rate and total hematological response rate
Measured: About 13 weeks from the first medication to the evaluation
Hematological response rate
Measured: About 26 weeks from the first medication to the evaluation
The time required for the first hematological response
Measured: About 26 weeks from the first medication to the evaluation
Changes in platelet count relative to the baseline of each visiting point of view
Measured: About 26 weeks from the first medication to the evaluation
Changes in hemoglobin relative to the baseline of each visiting point of view
Measured: About 26 weeks from the first medication to the evaluation
Changes in absolute neutrophil count relative to the baseline of each visiting point of view
Measured: About 26 weeks from the first medication to the evaluation
Changes in reticulocyte count relative to the baseline of each visiting point of view
Measured: About 26 weeks from the first medication to the evaluation
Cumulative proportion of patients who need blood transfusion
Measured: About 26 weeks from the first medication to the evaluation
Cumulative total amount of platelet transfusions
Measured: About 26 weeks from the first medication to the evaluation
Cumulative amount of red blood cell infusions
Measured: About 26 weeks from the first medication to the evaluation
Cumulative proportion of patients with disease progression
Measured: About 26 weeks from the first medication to the evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start26 Apr 2023
- Primary completion30 May 2024 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-severe Aplastic AnemiaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.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
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797623
- Sponsor's protocol ID
- SHR8735-201
- Status last verified
- Mar 2023
- First submitted
- 22 Mar 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, and Open-label, Placebo-controlled Phase II Clinical Study of Trappa Ethanolamine Tablets Combined With Ciclosporin in Patients With Treatment of Non-severe Aplastic Anemia
- ClinicalTrials.gov ID
- NCT05797623
- Acronym / sponsor ID
- SHR8735-201
- Conditions
- Non-severe Aplastic Anemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 4 Apr 2023 (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.
This is a multicenter, randomized, double-blind, and open-label, placebo-controlled phase II clinical study. In order to evaluate the effectiveness and safety of trappa ethanolamine tablets combined with ciclosporin in the treatment of patients with non-severe aplastic anemia.
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 |
|---|---|---|
| Trappa ethanolamine tablets combined with ciclosporin | Experimental | Drug: Trappa ethanolamine tablets ; ciclosporin |
| Placebo combined with ciclosporin | Placebo comparator | Drug: Placebo ; ciclosporin |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 14-75 years old (including boundary value, whichever is at the time of signing the informed consent form), Gender is not limited.
- Diagnosed with non-heavy aplastic anemia within 6 months
- Life Functional Status (ECOG) Score 0-1
- Those who understand the research procedures and methods, voluntarily participate in this experiment, and sign the informed consent form in writing
Key exclusion criteria (20 listed)
- Total blood cell loss and myelohypoproliferative diseases caused by other reasons
- Chromosome karyotype analysis during screening shows clonal cytogenetic abnormalities
- Meet the severe aplastic anemia
- Paroxysmal sleep hemoglobinuria (PNH) clone ≥50% or hemolytic PNH clone
- Randomly receive ATG, ciclosporin, TPO-R agonists, androgens and other drugs to treat the relapse without completing the elution
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 |
|---|---|---|
| Trappa ethanolamine tablets ; ciclosporinTrappa ethanolamine tablets combined with ciclosporin | Drug | Trappa ethanolamine tablets combined with ciclosporin |
| Placebo ; ciclosporinPlacebo combined with ciclosporin | Drug | Placebo combined with ciclosporin |
Primary outcome
Full hematological response rate
Time frame: About 13 weeks from the first medication to the evaluation.
11 secondary outcomes
Partial hematological response rate and total hematological response rate
Time frame: About 13 weeks from the first medication to the evaluation
Hematological response rate
Time frame: About 26 weeks from the first medication to the evaluation
The time required for the first hematological response
Time frame: About 26 weeks from the first medication to the evaluation
Changes in platelet count relative to the baseline of each visiting point of view
Time frame: About 26 weeks from the first medication to the evaluation
Changes in hemoglobin relative to the baseline of each visiting point of view
Time frame: About 26 weeks from the first medication to the evaluation
Changes in absolute neutrophil count relative to the baseline of each visiting point of view
Time frame: About 26 weeks from the first medication to the evaluation
Changes in reticulocyte count relative to the baseline of each visiting point of view
Time frame: About 26 weeks from the first medication to the evaluation
Cumulative proportion of patients who need blood transfusion
Time frame: About 26 weeks from the first medication to the evaluation
Cumulative total amount of platelet transfusions
Time frame: About 26 weeks from the first medication to the evaluation
Cumulative amount of red blood cell infusions
Time frame: About 26 weeks from the first medication to the evaluation
Cumulative proportion of patients with disease progression
Time frame: About 26 weeks from the first medication to the evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Trappa ethanolamine tablets ; ciclosporin in people with Non-severe Aplastic Anemia, run by Jiangsu HengRui Medicine Co., Ltd. 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 4 inclusion and 20 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 1 Sep 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wanyi Zhai (0518-82342973, wanyi.zhai.wz5@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Full hematological response rate (time frame: About 13 weeks from the first medication to the evaluation.). 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 1 Sep 2023.