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A prospective, single-arm, exploratory study of avatrombopag in the treatment of thrombocytopenia with TPO or TPORA ineffective

A prospective, single-arm, exploratory study of avatrombopag in the treatment of thrombocytopenia with TPO or TPORA ineffective

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061853
Enrollment
Unknown
Registered
2022-07-04
Start date
2022-06-20
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

thrombocytopenia with TPO or other TPORA ineffective

Interventions

Sponsors

The Forth Affiliated Hospital Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years, male or female; 2. ECOG PS score of physical condition: 0-2 points; 3. Platelet count = 3 months; 6. Those who have not participated in clinical trials of other drugs within 4 weeks before enrollment; 7. Subjects fully understand and voluntarily participate in this study and sign informed consent; 8. Those who are expected to have good compliance can follow up the efficacy and adverse reactions according to the program requirements.

Exclusion criteria

Exclusion criteria: 1. Any history of arterial or venous thrombosis within 6 months before screening; 2. Severe cardiovascular disease (such as NYHA cardiac function score III-IV) within 6 months before screening, arrhythmias known to increase the risk of thromboembolism such as atrial fibrillationatrial fluttercoronary stenting, angioplasty patients after coronary artery bypass grafting and coronary artery bypass grafting;; 3. Patients with known or expected hypersensitivity or intolerance to the active ingredients or excipients of avatrombopag; 4. Women in pregnancy, preparation for pregnancy or breast feeding period; 5. Serious neurological or psychiatric history; 6. Unsuitable subjects for this study determined by the investigator.

Design outcomes

Primary

MeasureTime frame
Clinical efficacy;

Secondary

MeasureTime frame
Effective time;Cumulative number of days of platelet response;Safety;

Countries

China

Contacts

Public ContactHuang Jian

The Forth Affiliated Hospital Zhejiang University School of Medicine

househuang@zju.edu.cn+86 13588010568

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026