Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 11:47 PM
Study NCT ID:
NCT06658834
Status:
RECRUITING
Last Update Posted:
2024-10-26
First Post:
2024-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Romiplostim N01 as the First-line Treatment for Newly Diagnosed Adult Patients With ITP
Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Organization:
Study Overview
Official Title:
A Multicenter Interventional Study of Romiplostim N01 Combined With Glucocorticoids as the First-line Treatment for Newly Diagnosed Adult Patients With ITP
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a multicenter interventional research on the first-line treatment of newly diagnosed adult patients with immune thrombocytopenia (ITP) using romiplostim N01 in combination with glucocorticoids. The primary endpoint of this study is to assess the efficacy of romiplostim N01 combined with glucocorticoids in untreated newly diagnosed adult ITP patients after 6 months of administration.
The subjects will be divided into the experimental group and the control group for treatment.
Experimental group: Dexamethasone (HD-DXM) 40mg/d × 4 days, one cycle. If there is no response on the 10th day, repeat once, administered either orally or intravenously. Simultaneously, romiplostim N01 is administered at an initial dose of 3µg/kg, by subcutaneous injection, once a week, for a maximum of 6 months.
Control group: Dexamethasone (HD-DXM) 40mg/d × 4 days, one cycle. If there is no response on the 10th day, repeat once, administered either orally or intravenously.
The subjects will be divided into the experimental group and the control group for treatment.
Experimental group: Dexamethasone (HD-DXM) 40mg/d × 4 days, one cycle. If there is no response on the 10th day, repeat once, administered either orally or intravenously. Simultaneously, romiplostim N01 is administered at an initial dose of 3µg/kg, by subcutaneous injection, once a week, for a maximum of 6 months.
Control group: Dexamethasone (HD-DXM) 40mg/d × 4 days, one cycle. If there is no response on the 10th day, repeat once, administered either orally or intravenously.
Detailed Description:
This study is a multicenter interventional research, and it is planned to incorporate 129 newly diagnosed adult ITP patients who have not undergone treatment.
For patients meeting the inclusion criteria, after signing the informed consent and passing the screening, they will be randomly grouped.
The study encompasses a screening period (from the signing of the informed consent form by the subject to before the first administration of the drug), a treatment period (including dexamethasone monotherapy and combined treatment of dexamethasone and romiplostim N01), and a follow-up period.
Screening period: Assess the inclusion and exclusion criteria. Those who fulfill the conditions can enter the treatment period.
Treatment period: Baseline visits are conducted for the screened eligible subjects, and they are randomly assigned to the experimental group and the control group at a ratio of 2:1.
Administration protocol:
Experimental group: Dexamethasone (HD-DXM) 40mg/d × 4d, one cycle. If there is no response on the 10th day, repeat once, administered orally or intravenously. Simultaneously, romiplostim N01 is administered, with an initial dose of 3µg/kg, by subcutaneous injection once a week, for up to 6 months.
Control group: Dexamethasone (HD-DXM) 40mg/d × 4d, one cycle. If there is no response on the 10th day, repeat once, administered orally or intravenously.
\*Dosage of romiplostim N01: The initial dose is 3µg/kg and can be initiated within 4 days of dexamethasone treatment.
When the platelet count is \< 50 × 10\^9/L, the patient will receive an increment in the dose of romiplostim N01 by 2µg/kg weekly, with a maximum dose of 10µg/kg. When 200 × 10\^9/L \> platelet count ≥ 50 × 10\^9/L, the administration dosage remains unchanged. When 400 × 10\^9/L \> platelet count ≥ 200 × 10\^9/L for two consecutive weeks, the dose is reduced by 1µg/kg. When the platelet count is ≥ 400 × 10\^9/L, discontinue the drug. When the platelet count \< 200 × 10\^9/L, resume administration, and the administration dose is 1µg/kg less than before drug cessation.
Follow-up period: Enter the follow-up period after the conclusion of treatment. Follow-up: Collect all adverse events (AEs) considered related to the study drug, follow up until the 14th week after the end of treatment, through clinical follow-up or telephone follow-up, and collect information on AEs, concomitant medications and concomitant treatments of the subjects. The researcher can increase the number of visits as necessary for AE follow-up to monitor the alleviation of AEs.
For patients meeting the inclusion criteria, after signing the informed consent and passing the screening, they will be randomly grouped.
The study encompasses a screening period (from the signing of the informed consent form by the subject to before the first administration of the drug), a treatment period (including dexamethasone monotherapy and combined treatment of dexamethasone and romiplostim N01), and a follow-up period.
Screening period: Assess the inclusion and exclusion criteria. Those who fulfill the conditions can enter the treatment period.
Treatment period: Baseline visits are conducted for the screened eligible subjects, and they are randomly assigned to the experimental group and the control group at a ratio of 2:1.
Administration protocol:
Experimental group: Dexamethasone (HD-DXM) 40mg/d × 4d, one cycle. If there is no response on the 10th day, repeat once, administered orally or intravenously. Simultaneously, romiplostim N01 is administered, with an initial dose of 3µg/kg, by subcutaneous injection once a week, for up to 6 months.
Control group: Dexamethasone (HD-DXM) 40mg/d × 4d, one cycle. If there is no response on the 10th day, repeat once, administered orally or intravenously.
\*Dosage of romiplostim N01: The initial dose is 3µg/kg and can be initiated within 4 days of dexamethasone treatment.
When the platelet count is \< 50 × 10\^9/L, the patient will receive an increment in the dose of romiplostim N01 by 2µg/kg weekly, with a maximum dose of 10µg/kg. When 200 × 10\^9/L \> platelet count ≥ 50 × 10\^9/L, the administration dosage remains unchanged. When 400 × 10\^9/L \> platelet count ≥ 200 × 10\^9/L for two consecutive weeks, the dose is reduced by 1µg/kg. When the platelet count is ≥ 400 × 10\^9/L, discontinue the drug. When the platelet count \< 200 × 10\^9/L, resume administration, and the administration dose is 1µg/kg less than before drug cessation.
Follow-up period: Enter the follow-up period after the conclusion of treatment. Follow-up: Collect all adverse events (AEs) considered related to the study drug, follow up until the 14th week after the end of treatment, through clinical follow-up or telephone follow-up, and collect information on AEs, concomitant medications and concomitant treatments of the subjects. The researcher can increase the number of visits as necessary for AE follow-up to monitor the alleviation of AEs.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: