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New treatment option for Aplastic Anemia
Official title Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia
ClinicalTrials.gov ID: NCT06613880
What this study is testing
What is standard IST combined with Romiplostim N01?
standard IST combined with Romiplostim N01 is an investigational medicine, being studied as a potential treatment for aplastic anemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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
- Willing and able to comply with the requirements for this study and written informed consent.
You likely can't join if
- 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
- Allergy to ALG
- Presence of uncontrolled active infection
See the full eligibility criteria
- 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
- Willing and able to comply with the requirements for this study and written informed consent.
- 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
- Allergy to ALG
- Presence of uncontrolled active infection
- Presence of uncontrolled hypertension (≥140/90mmHg), diabetes mellitus (fasting blood glucose≥ 7.0 mmol/L or random blood glucose ≥ 11.1 mmol/L)
- Abnormal liver and kidney function: Aspartate Transaminase (AST) or Alanine Transaminase (ALT) \> 3 ULN, creatinine ≥ 2.5 ULN
- History of chemoradiotherapy for malignant solid tumors
- History of other systemic serious illnesses
- Females who are pregnant/lactating or need pregnancy
- Patients considered to be ineligible for the study by the investigator for reasons other than the above
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.