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Study on Glucocorticoid Combined With Gamma Globulin and Ropristine N01 in Treatment of Initial Severe ITP
Plain-language guide to NCT06686927: phase 2 interventional trial of Romiplostim, 36 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06686927
- Phase
- phase 2
- Status
- status unknown
- Start
- 2024-11-20
- Completion (planned or actual)
- 2025-09-20
- Participants
- 36 (estimated)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Primary Immune Thrombocytopenia
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Romiplostim.
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.
It had 1 arm (groups): Corticosteroids combined with immunoglobulin and romiplostim (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 36 planned participants were the target.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Participants must sign a written informed consent prior to enrollment;. 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 romiplostim treatment;. ECOG PS score: 0-2;.
The full record lists 9 inclusion and 8 exclusion criteria; among the exclusions: individuals with a history of thrombosis;; pregnant or lactating individuals;; individuals with severe cardiopulmonary insufficiency;.
How the Study Was Run
Design: single-group and open-label.
Nothing was hidden in this open-label Romiplostim study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2024-11-20 with completion listed for 2025-09-20.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 4 secondary outcomes, for example Early (week) response rate R, Early Complete Response Rate (CR), Time to Reaction and Adverse events during treatment.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Romiplostim in 36 people.
Its size is small, so on its own it can only give an early look.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Romiplostim compound page, all human trials.
Our Notes on the Compound
Romiplostim: A peptide-antibody fusion (peptibody) that activates the thrombopoietin receptor to raise platelet counts; sold as Nplate.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.