NCT06992128

Romiplostim N01 Combined With Glucocorticoids as the First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Multicenter, Interventional Trial

Romiplostim N01 Combined With Glucocorticoids as the First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia (ITP): A Multicenter, Interventional Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This prospective, multicenter, randomized study aim to evaluate the efficacy and safety of romiplostim N01 combined with glucocorticoids as the first-line treatment for newly diagnosed adult primary immune thrombocytopenia (ITP).

Detailed description

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. 129 eligible subjects were randomized to either romiplostim N01 combining glucocorticoids or glucocorticoids treatment in 2:1 ratio. 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. The initial dose of romiplostim N01 administration was 3µg/kg and can be initiated within 4 days of dexamethasone treatment. The dose of romiplostim N01 was adjusted according to the subject platelet count during the treatment period. 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. All subjects were followed up until the 24th week after the end of treatment through clinical follow-up or telephone follow-up. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events, concomitant medications and concomitant treatments are also recorded throughout the study. The researcher can increase the number of visits as necessary for AE follow-up to monitor the alleviation of AEs.

Conditions

• Primary Immune Thrombocytopenia (ITP)

Interventions

Type	Name	Description
DRUG	Romiplostim N01 combined with dexamethasone	Dexamethasone (HD-DXM) at a dose of 40mg/d for 4 days constitutes one cycle. If there is no response on the 10th day, repeat it once. The administration can be either oral or intravenous. Meanwhile, romiplostim N01 is administered with an initial dose of 3µg/kg by subcutaneous injection within 4 days of dexamethasone treatment once a week for up to 6 months.
DRUG	Dexamethasone monotherapy	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.

Timeline

• Start date: 2025-05-22
• Primary completion: 2028-01-31
• Completion: 2028-08-31
• First posted: 2025-05-28
• Last updated: 2025-05-28

Locations

1 site across 1 country: China