Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

This prospective, single center, single-arm study aims to evaluate the efficacy and safety of anti-human T lymphocyte porcine immunoglobulin (p-ALG) in combination with cyclosporine and Romiplostim in treating severe aplastic anemia (SAA). It will include 48 patients with newly diagnosed SAA.

Eligibility criteria

Qualifiers

Age ≥ 12 years

Diagnosis of severe or very severe aplastic anemia

Patients are unconditionally or unacceptable undergoing allogeneic hematopoietic stem cell transplantation

ECOG performance status ≤2

Disqualifiers

Received > 4 weeks of TPO-RA drug before treatment

Received > 4 weeks of immunosuppressive therapy before treatment

History of thromboembolic disease

Intolerance to Romiplostim N01 or cyclosporine

Trial design

Treatments tested in this trial

  • standard IST combined with Romiplostim N01

Treatment groups

48 Participants
are divided into 1 treatment group

Locations

1
Regenerative Medicine Center and Red Blood Cell Disorders Center TianjinTianjin Municipality, China

Sponsors and collaborators

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Collaborator