Health TrialsbyHealthPanel

Efficacy and Safety of Avatrombopag in the Treatment of Thrombocytopenia After Haplo-HSCT

ConditionsThrombocytopeniaStem Cell Transplant Complications
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPeking University People's Hospital

About this trial

In this study, investigators aim to evaluate the efficacy of avatrombopag in thrombocytopenic patients after haploidentical hematopoietic stem cell transplantation (haplo-HSCT) through a prospective, multi-center, double-blinded, randomized placebo-controlled clinical trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, aged between 18-65 years;

PLT<20×10^9/L or transfusion dependent on +D7 after haplo-HSCT;

Agree to receive the treatment of avatrombopag after Haplo-HSCT and sign the informed consent form.

Disqualifiers

With active infection;

ALT or AST>3ULN, or total Bil>2ULN

Ccr<50 mL/min;

With the history of arteriovenous thrombosis;

Trial design

Design model

Parallel

Treatments tested in this trial

  • avatrombopag

    Drug

    The avatrombopag 20mg/d will be orally taken from +D7 after haplo-HSCT until meeting the adjustment indication or to +D60 after haplo-HSCT; When PLT\<50×10\^9/L or PLT transfusion-dependent on the +D30 after haplo-HSCT, increase avatrombopag dosage to 40 mg/d; When PLT≥80×10\^9/L and without PLT transfusion within avatrombopag dosage at 40 mg/d, decrease avatrombopag dosage to 20 mg/d; When PLT≥80×10\^9/L for 7 consecutive days or PLT≥300×10\^9/L and without PLT transfusion, stop avatrombopag; When PLT\<50×10\^9/L or PLT transfusion-dependent after stopping avatrombopag , reuse avatrombopag at 40 mg/d.

  • Placebo

    Drug

    The placebo 20mg/d will be orally taken from +D7 after haplo-HSCT until meeting the adjustment indication or to +D60 after haplo-HSCT; When PLT\<50×10\^9/L or PLT transfusion-dependent on the +D30 after haplo-HSCT, increase placebo dosage to 40 mg/d; When PLT≥80×10\^9/L and without PLT transfusion within placebo dosage at 40 mg/d, decrease placebo dosage to 20 mg/d; When PLT≥80×10\^9/L for 7 consecutive days or PLT≥300×10\^9/L and without PLT transfusion, stop placebo; When PLT\<50×10\^9/L or PLT transfusion-dependent after stopping placebo, reuse placebo at 40 mg/d.

Treatment groups

142 Participants
are divided into 2 treatment groups
Group A: avatrombopagExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

the proportion of complete response(CR) on day 60 after haplo-HSCT

the proportion of participants whose PLT≥50×10\^9/L on day 60 after haplo-HSCT independent of PLT transfusion for 7 consecutive days or above

Time frame
from randomization to day 60 after haplo-HSCT

Secondary outcomes

1

the proportion of resonse(R)/remission on day 60 after haplo-HSCT

the proportion of participants whose PLT≥20×10\^9/L or PLT≥100×10\^9/L on day 60 after haplo-HSCT independent of PLT transfusion for 7 consecutive days or above

Time frame
from randomization to day 60 after haplo-HSCT
2

the proportion of R/CR on day 30 after haplo-HSCT

the proportion of participants whose PLT≥20×10\^9/L or PLT≥50×10\^9/L on day 30 after haplo-HSCT independent of PLT transfusion for 7 consecutive days or above,respectively

Time frame
from randomization to day 30 after haplo-HSCT
3

the proportion of CR/remission on day 90 after haplo-HSCT

the proportion of participants whose PLT≥50×10\^9/L or PLT≥100×10\^9/L on day 90 after haplo-HSCT independent of PLT transfusion for 7 consecutive days or above

Time frame
from randomization to day 90 after haplo-HSCT
4

Time to R/CR/remission

the first day of the time to achieve PLT≥20×10\^9/L and PLT≥50×10\^9/L or PLT≥100×10\^9/L independent of PLT transfusion for consecutive 7 days and above within 60 days after haplo-HSCT,respectively

Time frame
from randomization to day 60 after haplo-HSCT

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University People's Hospital

Lead sponsor

Xiangya Hospital of Central South University

Collaborator

Sichuan Provincial People's Hospital

Collaborator

First Affiliated Hospital of Harbin Medical University

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator

First Affiliated Hospital of Xinjiang Medical University

Collaborator

Shanxi Bethune Hospital

Collaborator

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Collaborator

Tang-Du Hospital

Collaborator

The First Affiliated Hospital of Nanchang University

Collaborator

Source ClinicalTrials.gov
Apply now