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New treatment option for Immune Thrombocytopenia
Official title Avatrombopag in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies
ClinicalTrials.gov ID: NCT04993885
What this study is testing
What is Avatrombopag?
Avatrombopag is an investigational medicine, given as an once-weekly, being studied as a potential treatment for immune thrombocytopenia.
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, open-label, single-center, one-arm clinical trial aims at evaluating the efficacy and safety of avatrombopag in Chinese adult Immune Thrombocytopenia (ITP) patients with autoantibodies fail (due to intolerance or resistance) to eltrombopag or herombopag treatment.
- 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 18 and older
You may be able to join if
- The patients have provided written informed consent prior to enrollment.
- Men and women greater than or equal to 18 years of age.
- Diagnosed as ITP secondary to connective tissue diseases (including but not limited to systemic lupus erythematosus, Sjogren's syndrome and...
- Platelet count\<30 ×10\^9/L at screening.
- Patients who have previously failed to receive Eltrombopag or Herombopag [poor how well it works (Eltrombopag 75 mg/d or Herombopag 7.5 mg/D, at...
You likely can't join if
- Patients with active thyroid disease requiring treatment.
- Patients with any prior history of arterial or venous thrombosis within 3 months, and with any of the following risk factors: cancer, Factor V...
- Those who had received rituximab within 3 months.
- Patients who had failed to respond to the previous use of Avatrombopag (40mg once a day for more than 4 weeks).
- people known to be allergic to Avatrombopag or any of its excipients.
- Patients who had received splenectomy within 3 months or have splenectomy plan within 3 months.
See the full eligibility criteria
- The patients have provided written informed consent prior to enrollment.
- Men and women greater than or equal to 18 years of age.
- Diagnosed as ITP secondary to connective tissue diseases (including but not limited to systemic lupus erythematosus, Sjogren's syndrome and rheumatoid arthritis), primary ITP with positive antinuclear antibody but not...
- Platelet count\<30 ×10\^9/L at screening.
- Patients who have previously failed to receive Eltrombopag or Herombopag [poor how well it works (Eltrombopag 75 mg/d or Herombopag 7.5 mg/D, at least 4 weeks), or the how well it works cannot be maintained], or who...
- Treatment for ITP (including but not limited to glucocorticoids, recombinant human thrombopoietin, and other thrombopoietin receptor agonists other than Avatrombopag) must be completed before enrollment, or the dose...
- Effective contraceptive measures will be taken during the clinical trial.
- Patients with active thyroid disease requiring treatment.
- Patients with any prior history of arterial or venous thrombosis within 3 months, and with any of the following risk factors: cancer, Factor V Leiden, ATIII deficiency, or patients who are using anticoagulants or...
- Those who had received rituximab within 3 months.
- Patients who had failed to respond to the previous use of Avatrombopag (40mg once a day for more than 4 weeks).
- people known to be allergic to Avatrombopag or any of its excipients.
- Patients who had received splenectomy within 3 months or have splenectomy plan within 3 months.
- Patients with lupus encephalopathy or lupus nephritis.
- Patients with cataract.
- Patients with infectious fever (including but not limited to pulmonary infection) within 1 month or with active infection during screening.
- Existing hepatitis B virus, hepatitis C virus replication or HIV infection.
- Severe liver dysfunction (alanine aminotransferase or glutamic oxaloacetic transaminase \> 3×ULN).
- Patients with severe cardiac or pulmonary dysfunction.
- Severe renal damage (creatinine clearance \< 30 ml/min).
- There are surgical planners during the study.
- History of psychiatric disorder.
- Pregnant or lactating women or those planning to be pregnant during the trial.
- Patients with a history of drug/alcohol abuse (within 2 years before the study).
- Patients that had participated in other experimental researches within one month before enrollment.
- Any other circumstances that the investigator considers that the patient is not suitable to participate in the trial.
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, 18 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.