Avatrombopag Combined With IST as First-line Treatment for SAA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-10

Study Completion Date

2024-11-30

Brief Summary

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This single-center study aims to evaluate the early efficacy and safety of avatrombopag combined with immunosuppressive therapy (IST) in the first-line treatment of severe aplastic anemia (SAA).

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Detailed Description

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This is a single center, single arm, phase II clinical study. Fifty-three patients will be enrolled.

Treatment protocol is as follows: 1) Anti-human thymocyte porcine immunoglobulin (P-ATG 20mg/kg/d) or rabbit anti human thymocyte globulin (R-ATG 3.0mg/kg/d) was administered intravenously for 5 days; 2) Cyclosporine (CSA) is given at 3-5 mg/kg.d in divided doses for at least 6 months. The trough concentration is maintained at 150-250 ng/ml. 3) Avatrombopag is given orally at 60 mg once a day for patients with body weight ≥ 50 kg, and 40 mg orally once a day for patients with body weight\<50 kg, for a total of 12 weeks.

Conditions

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Severe Aplastic Anemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

53 subjects will be enrolled with the indicated treatment dose of avatrombopag.

Group Type EXPERIMENTAL

avatrombopag

Intervention Type DRUG

Patients with body weight ≥50kg were given 60mg/day and patients with body weight \< 50kg were given 40mg/day for 12 weeks.

Interventions

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avatrombopag

Patients with body weight ≥50kg were given 60mg/day and patients with body weight \< 50kg were given 40mg/day for 12 weeks.

Intervention Type DRUG

Other Intervention Names

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AVA APAG

Eligibility Criteria

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Inclusion Criteria

1. Patients with newly diagnosed severe aplastic anemia.
2. Men and women aged between 12 and 60.
3. Subjects must complete all screening assessments as outlined in the test protocol.
4. Able to swallow or administer orally.
5. Before the start of the research procedure, the patient or guardian should fully understand the research procedure and purpose and sign the informed consent form. If the patient's signature is not conducive to the treatment of the disease, the patient's immediate family should sign the informed consent form.

Exclusion Criteria

1. Congenital bone marrow failure (eg. Fanconi anemia).
2. Accompanied by cytogenetic cloning changes (chromosomal karyotype and FISH detection found somatic cloning abnormalities; Simple -Y abnormality can be included in this study;) .
3. ATG or middle/high-dose cyclophosphamide was used in the past.
4. Previous treatment with cyclosporine or tacrolimus \> 6 months.
5. The total course of treatment with TPO receptor agonists (including thrombopoietin, eltrombopag,hetrombopag and avatrombopag) was more than 1 month.
6. Serious infectious diseases (tuberculosis without effective control, pulmonary aspergillosis, viral infections).
7. AIDS patients.
8. Pregnant or breastfeeding, fertile but unwilling to take effective contraceptive measures.
9. Patients with malignant tumors who are not suitable for ATG treatment.
10. A newly diagnosed history of cardio/cerebral vascular thrombosis within 12 months.
11. Those who are assessed as unsuitable for inclusion by the investigator.

Minimum Eligible Age

12 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No