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A real-world study on the treatment of aplastic anemia with Romiplostim N01

The efficacy and safety of Romiplostim N01 in the treatment of patients with aplastic anemia: A multicenter, prospective real-world study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500115698
Enrollment
Unknown
Registered
2025-12-30
Start date
2025-12-31
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with aplastic anemia (including severe AA and non-severe AA)

Interventions

Romiplostim N01 treatment group:NA

Sponsors

Hebei Province Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. >=18 years old, gender not limited; 2. Both newly diagnosed and previously treated patients with aplastic anemia (AA)(including SAA and NSAA) are eligible for enrollment; 3. Voluntarily sign a written informed consent form and be able to comply with the visitation and related procedures stipulated in the plan.

Exclusion criteria

Exclusion criteria: 1. Unable to comply with the study plan or procedures; 2. Congenital aplastic anemia (e.g., Fanconi anemia, congenital parakeratosis); 3. Patients who have previously received Romiplostim; 4. According to the investigator's judgment, those with concomitant diseases that seriously endanger patient safety or affect the patient's completion of the study; 5. The investigators considered patients unsuitable for inclusion in this study.

Design outcomes

Primary

MeasureTime frame
The hematological response rate;

Secondary

MeasureTime frame
The hematological responce rate and complete responce rate;Duration of hematological responce;The changes in reticulocytes and T-lymphocyte subsets of the patients;Evaluation of clonal evolution;The complete hematological responce rate ;The long-term safety and tolerance of Romiplostim N01;

Countries

China

Contacts

Public ContactZijing Guo

Hebei Province Hospital of Chinese Medicine

drzaking@163.com+86 311 69095527

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026