Recruiting PHASE2 Sever Aplastic Anaemia

New treatment option for Sever Aplastic Anaemia

Official title Dose-attenuated IST and Hetrombopag in Elderly (≥65 Years) Patients With Severe Aplastic Anemia

ClinicalTrials.gov ID: NCT07010237

What this study is testing

What is Dose-attenuated IST and Hetrombopag?

Dose-attenuated IST and Hetrombopag is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for sever aplastic anaemia.

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 is a prospetive,Single-Center, Single-Arm, Phase IIB Clinical Study.This study aims to evaluate the efficacy and safety of dose-attenuated IST combined with Hetrombopag in elderly patients (≥65 years) with VSAA/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 65 and older

You may be able to join if

  • Clinical diagnosis of VSAA/SAA.
  • Age ≥65 years.
  • Completion of all screening assessments.
  • Must be able to swallow tablets.
  • Signed informed consent (by patient or legal guardian if patient is incapacitated).

You likely can't join if

  • Clonal cytogenetic abnormalities (excluding isolated -Y or +8).
  • Prior treatment with ATG/high-dose cyclophosphamide.
  • Prior cyclosporine/tacrolimus use \>12 months.
  • Prior TPO-RA therapy \>3 months.
  • Uncontrolled malignancies or conditions contraindicating ATG.
  • Severe organ dysfunction (e.g., creatinine ≥177 μmol/L).
See the full eligibility criteria
Who can join
  • Clinical diagnosis of VSAA/SAA.
  • Age ≥65 years.
  • Completion of all screening assessments.
  • Must be able to swallow tablets.
  • Signed informed consent (by patient or legal guardian if patient is incapacitated).
What rules you out
  • Clonal cytogenetic abnormalities (excluding isolated -Y or +8).
  • Prior treatment with ATG/high-dose cyclophosphamide.
  • Prior cyclosporine/tacrolimus use \>12 months.
  • Prior TPO-RA therapy \>3 months.
  • Uncontrolled malignancies or conditions contraindicating ATG.
  • Severe organ dysfunction (e.g., creatinine ≥177 μmol/L).
  • Investigator judgment of unsuitability.

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, 65 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.