Primary Immune ThrombocytopeniaPhase 2NCT06686927
Study on Glucocorticoid Combined With Gamma Globulin and Ropristine N01 in Treatment of Initial Severe ITP
A Phase 2 study testing corticosteroids combined with immunoglobulin and romiplostim in people with Primary Immune Thrombocytopenia, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if romiplostim N01 works to treat severe primary immune thrombocytopenia in adults. It will also learn about the safety of romiplostim N01. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Immune Thrombocytopenia
- What is being tested?
- corticosteroids combined with immunoglobulin and romiplostim
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2024to 20 Dec 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must sign a written informed consent prior to enrollment;
- Ages 18-75;
- Platelet count <10×10^9/L with active bleeding or bleeding score ≥5;
- No contraindications to the use of steroids, romiplostim, or IVIG, and willingness to receive these treatments;
- No prior splenectomy or at least one first-line ITP treatment or emergency treatment;
- No prior romiplostim treatment;
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- ECOG PS score: 0-2;
- Female participants of childbearing potential must agree to use reliable contraception (including male or female condoms, contraceptive foam, contraceptive jelly, contraceptive patches, contraceptive cream, contraceptive suppositories, abstinence, and placement of intrauterine contraceptive devices) throughout the study; women who have had a hysterectomy, bilateral oophorectomy, bilateral salpingo-oophorectomy, or have been postmenopausal for more than 1 year, and men who have had bilateral vasectomy or vasectomy are excluded;
- Voluntary participation in this study and good compliance.
Who cannot join
- Individuals with the following hematological disorders other than ITP, including but not limited to leukemia, thrombocytopenia caused by cancer treatment, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome;
- Individuals with a history of thrombosis;
- Pregnant or lactating individuals;
- Individuals with severe cardiopulmonary insufficiency;
- Individuals with severe or uncontrollable infections;
- Individuals with viral infections;
- Individuals who cannot comply due to psychological reasons;
- Individuals who are deemed unsuitable for participation in the study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Yu Hu, MD, 027-85726114, dr_huyu387@163.com
Liang Tang, 13554153411, lancet.tang@qq.com
About this study
The goal of this clinical trial is to learn if romiplostim N01 works to treat severe primary immune thrombocytopenia in adults. It will also learn about the safety of romiplostim N01. The main question it aims to answer is:
TO evaluate the effectiveness of the combination treatment of glucocorticoids, gamma globulin and romiplostim N01 in patients with severe primary immune thrombocytopenia during the initial treatment period for one month.
Read more
Participants will:
Romiplostim N01, starting dose of 1 µg/kg, subcutaneous injection, given on the third day of IVIG, once a week, for up to one month.
IVIG, 400mg/kg/d, intravenous administration, continuous administration for 3-5 days.
Prednisone, 0.8mg/kg/d, taken orally or intravenously, for up to one month.
- Conditions
- Primary Immune Thrombocytopenia
- Being tested
- corticosteroids combined with immunoglobulin and romiplostim
- Keywords
- severe ITP, Romiplostim
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corticosteroids combined with immunoglobulin and romiplostimDrug
Romiplostim N01, starting dose of 1 µg/kg, subcutaneous injection, given on the third day of IVIG, once a week, for up to one month.
IVIG, 400mg/kg/d, intravenous administration, continuous administration for 3-5 days.
Prednisone, 0.8mg/kg/d, taken orally or intravenously, for up to one month.
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroids combined with immunoglobulin and romiplostim | Experimental | Romiplostim N01, starting dose of 1 µg/kg, subcutaneous injection, given on the third day of IVIG, once a week, for up to one month.
IVIG, 400mg/kg/d, intravenous administration, continuous administration for 3-5 days.
Prednisone, 0.8mg/kg/d, taken orally or intravenously, for up to one month. Receives: Drug: corticosteroids combined with immunoglobulin and romiplostim |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total effective rate of treatment for 30 days
GR = CR + R (Complete reaction CR, platelet count ≥ 100×10^9/L, and no bleeding symptoms; Effective R, platelet count between 30×10^9/L and 100×10^9/L, and at least double the baseline value, and no bleeding symptoms)
Measured: one months
Secondary outcomes (4)
Early (week) response rate R
Effective R, platelet count between 30×10^9/L and 100×10^9/L, and at least double the baseline value, and no bleeding symptoms
Measured: one months
Early Complete Response Rate (CR)
Complete reaction CR, platelet count ≥ 100×10^9/L, and no bleeding symptoms
Measured: one months
Time to Reaction
Time of Starting Treatment Until Platelet Count ≥ 30×10^9/L
Measured: one months
Adverse events during treatment
evaluated using Version 5.0 of the "Common Terminology Criteria for Adverse Events(NCI CTC AE)"
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start20 Nov 2024
- Primary completion20 Sep 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, Institute of Hematology & Blood Diseases Hospital, China, The First Affiliated Hospital of Soochow University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686927
- Sponsor's protocol ID
- 2024-0503
- Status last verified
- Aug 2024
- First submitted
- 11 Nov 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Glucocorticoid Combined With Gamma Globulin and Ropristine N01 in Treatment of Initial Severe ITP
- ClinicalTrials.gov ID
- NCT06686927
- Acronym / sponsor ID
- 2024-0503
- Conditions
- Primary Immune Thrombocytopenia
- Keywords
- severe ITP, Romiplostim
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, Institute of Hematology & Blood Diseases Hospital, China, The First Affiliated Hospital of Soochow University
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 13 Nov 2024 (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 goal of this clinical trial is to learn if romiplostim N01 works to treat severe primary immune thrombocytopenia in adults. It will also learn about the safety of romiplostim N01. The main question it aims to answer is:
TO evaluate the effectiveness of the combination treatment of glucocorticoids, gamma globulin and romiplostim N01 in patients with severe primary immune thrombocytopenia during the initial treatment period for one month.
Participants will:
Romiplostim N01, starting dose of 1 µg/kg, subcutaneous injection, given on the third day of IVIG, once a week, for up to one month.
IVIG, 400mg/kg/d, intravenous administration, continuous administration for 3-5 days.
Prednisone, 0.8mg/kg/d, taken orally or intravenously, for up to one month.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Corticosteroids combined with immunoglobulin and romiplostim | Experimental | Drug: corticosteroids combined with immunoglobulin and romiplostimRomiplostim N01, starting dose of 1 µg/kg, subcutaneous injection, given on the third day of IVIG, once a week, for up to one month. IVIG, 400mg/kg/d, intravenous administration, continuous administration for 3-5 days. Prednisone, 0.8mg/kg/d, taken orally or intravenously, for up to one month. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants must sign a written informed consent prior to enrollment;
- Ages 18-75;
- Platelet count <10×10^9/L with active bleeding or bleeding score ≥5;
- No contraindications to the use of steroids, romiplostim, or IVIG, and willingness to receive these treatments;
- No prior splenectomy or at least one first-line ITP treatment or emergency treatment;
Key exclusion criteria (8 listed)
- Individuals with the following hematological disorders other than ITP, including but not limited to leukemia, thrombocytopenia caused by cancer treatment, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome;
- Individuals with a history of thrombosis;
- Pregnant or lactating individuals;
- Individuals with severe cardiopulmonary insufficiency;
- Individuals with severe or uncontrollable infections;
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 |
|---|---|---|
| corticosteroids combined with immunoglobulin and romiplostimRomiplostim N01, starting dose of 1 µg/kg, subcutaneous injection, given on the third day of IVIG, once a week, for up to one month. IVIG, 400mg/kg/d, intravenous administration, continuous administration for 3-5 days. Prednisone, 0.8mg/kg/d, taken orally or intravenously, for up to one month. | Drug | Corticosteroids combined with immunoglobulin and romiplostim |
Primary outcome
The total effective rate of treatment for 30 days
Time frame: one months
GR = CR + R (Complete reaction CR, platelet count ≥ 100×10^9/L, and no bleeding symptoms; Effective R, platelet count between 30×10^9/L and 100×10^9/L, and at least double the baseline value, and no bleeding symptoms)
4 secondary outcomes
Early (week) response rate R
Time frame: one months
Early Complete Response Rate (CR)
Time frame: one months
Time to Reaction
Time frame: one months
Adverse events during treatment
Time frame: four months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- 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.
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 corticosteroids combined with immunoglobulin and romiplostim in people with Primary Immune Thrombocytopenia, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 9 inclusion and 8 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 22 Jan 2025. 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 Liang Tang (13554153411, lancet.tang@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total effective rate of treatment for 30 days (time frame: one months). 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 22 Jan 2025.