Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04993885
Other study ID # IIT2021033
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 1, 2021
Est. completion date September 30, 2024

Study information

Verified date November 2023
Source Institute of Hematology & Blood Diseases Hospital, China
Contact Rongfeng Fu, M.D.
Phone +862223909009
Email furongfeng@ihcams.ac.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

This prospective, open-label, single-center, one-arm clinical trial aims at evaluating the efficacy and safety of avatrombopag in Chinese adult ITP patients with autoantibodies fail (due to intolerance or resistance) to eltrombopag or herombopag treatment. The subjects include 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 up to the diagnostic criteria of connective tissue diseases, primary Evans syndrome, Evans syndrome secondary to connective tissue diseases, and primary ITP with positive Coomb's test but not up to the diagnostic criteria of Evans syndrome. Fifty-two eligible subjects will be enrolled in this study. The dose will be adjusted according to the platelet count during the period from week 1 to week 12.


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date September 30, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion 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 up to the diagnostic criteria of connective tissue diseases, primary Evans syndrome, Evans syndrome secondary to connective tissue diseases, and primary ITP with positive Coomb's test but not up to the diagnostic criteria of Evans syndrome. - Platelet count<30 ×10^9/L at screening. - Patients who have previously failed to receive Eltrombopag or Herombopag [poor efficacy (Eltrombopag 75 mg/d or Herombopag 7.5 mg/D, at least 4 weeks), or the efficacy cannot be maintained], or who have contraindications, can not tolerate or refuse Eltrombopag or Herombopag treatment. - 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 must be stable or in a phase of reduction within 2 weeks before enrollment. - Effective contraceptive measures will be taken during the clinical trial. Exclusion Criteria: - 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 antiplatelet drugs at the beginning of screening. - 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). - Subjects 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Avatrombopag
The subjects will receive avatrombopag treatment with an initial dose of 40mg once a day. Platelet counts will be obtained weekly during the first 4 weeks and then every 2 weeks until week 12 after treatment. The dose adjustment range is 20 mg per week to 40 mg per day to maintain the platelet level between 30×10^9/L and 200×10^9/L. If the platelet count does not reach to 30×10^9/L after taking avatrombopag 40mg once a day for 4 consecutive weeks, the treatment will be stopped.

Locations

Country Name City State
China Institute of Hematology & Blood Diseases Hospital Tianjin Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Institute of Hematology & Blood Diseases Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Incidence of Toxicity The proportion of subjects with specific pre-defined toxicity, including headache, fever, nausea and abdominal pain, and unpredictable toxicity. From the start of study treatment (Day 1) up to the end of week 12.
Primary Platelet response Percentage of participants achieving a platelet count >=30×10^9/L and at least doubling of the baseline count within 12 weeks of treatment. From the start of study treatment (Day 1) up to the end of week 12.
Secondary Platelet response Proportion of subjects who achieve response (R) within 1, 2, 4 and 8 weeks of treatment. From the start of study treatment (Day 1) up to the end of week 12.
Secondary Platelet response Proportion of subjects who achieve complete response (CR) within 4, 8 and 12 weeks of treatment. From the start of study treatment (Day 1) up to the end of week 12.
Secondary Duration of platelet response Proportion of subjects with a platelet count >=30×10^9/L for at least 4 consecutive weeks during the 12 week treatment period without remedial treatment. From the start of study treatment (Day 1) up to the end of week 12.
Secondary Platelet response Percentage of participants achieving a platelet count >=50×10^9/L within 12 weeks of treatment. From the start of study treatment (Day 1) up to the end of week 12.
Secondary Time to platelet response Time to response is defined as time from the start of treatment to the first time of achieving a platelet count >= 30×10^9/L and at least doubling of the baseline count during the whole 12 weeks. From the start of study treatment (Day 1) up to the end of week 12.
Secondary Duration of platelet response Total duration of time a participant with a response of R. From the start of study treatment (Day 1) up to the end of week 12.
Secondary Proportion of patients receiving remedial treatment. Proportion of patients receiving remedial treatment. From the start of study treatment (Day 1) up to the end of week 12.
Secondary Bleeding score The incidence and grade of bleeding symptoms according to the World Health Organization Bleeding Scale. From the start of study treatment (Day 1) up to the end of week 12.
Secondary Changes of disease activity index in patients with systemic lupus erythematosus The proportion of subjects with improvement of disease activity index in patients with systemic lupus erythematosus according to the SLEDAI standard. From the start of study treatment (Day 1) up to the end of week 12.
Secondary The improvement of symptoms The proportion of subjects with improvement of symptoms including skin symptom, joint pain, dry mouth and dry eyes. From the start of study treatment (Day 1) up to the end of week 12.
Secondary Improvement in immune indexes The proportion of subjects with improvement immune indexes including antinuclear antibody, extractable nuclear antigens spectrum and Coomb's test. From the start of study treatment (Day 1) up to the end of week 12.
Secondary Discontinuation rate of glucocorticoids The proportion of subjects with discontinuation use of glucocorticoids. From the start of study treatment (Day 1) up to the end of week 12.
Secondary Functional assessment of chronic illness therapy-fatigue In all participants, functional assessment of chronic illness therapy-fatigue questionnaire will be used to assess the health related quality of life before and after treatment. From the start of study treatment (Day 1) up to the end of week 12.
Secondary ITP-Patient Assessment Questionnaire In all participants, ITP-Patient Assessment Questionnaire will be used to assess the health related quality of life before and after treatment. From the start of study treatment (Day 1) up to the end of week 12.
See also
  Status Clinical Trial Phase
Completed NCT02287649 - Polymorphism and Auto-reactive B and T Cells Subsets in Adult's Immune Thrombocytopenia (ITP) N/A
Completed NCT02556814 - Caffeic Acid Combining High-dose Dexamethasone in Management of ITP Phase 4
Terminated NCT02401061 - PRTX-100-202 Open-Label, Dose Escalation Study in Adult Patients With ITP Phase 1/Phase 2
Completed NCT02868099 - Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP) Phase 3
Completed NCT02351622 - Caffeic Acid Tablets as a Second-line Therapy for ITP Phase 3
Active, not recruiting NCT04741139 - Post IVIG Medication in Children With Immune Thrombocytopenia Phase 1
Not yet recruiting NCT05494307 - The Combination of Terbutaline and Danazol as the Treatment of Corticosteroid-resistant/Relapse Immune Thrombocytopenia Phase 2
Not yet recruiting NCT05468866 - The Expression of Immune Checkpoint CD28 rs1980422-related Single-nucleotide Polymorphisms in the Primary Immune Thrombocytopenia N/A
Recruiting NCT05281068 - The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia Phase 2
Not yet recruiting NCT05020288 - A Clinical Trial of the Orelabrutinib in the Management of Refractory ITP Phase 2
Withdrawn NCT03965624 - Efficacy and Safety of Ixazomib and Dexamethasone Refractory Autoimmune Cytopenia Phase 2
Not yet recruiting NCT03252457 - Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP Phase 3
Recruiting NCT05937828 - OBS'CEREVANCE: French Cohort of Pediatric Autoimmune Cytopenia
Completed NCT03156452 - Newly Diagnosed Immune Thrombocytopenia Testing the Standard Steroid Treatment Against Combined Steroid & Mycophenolate Phase 3
Completed NCT03164915 - A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP) Phase 3
Recruiting NCT02270801 - Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP) in Pregnancy Phase 3
Withdrawn NCT01976195 - High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP Phase 2
Completed NCT01933035 - Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias. N/A
Recruiting NCT02821572 - Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)
Not yet recruiting NCT05562882 - A Clinical Trial to Assess Safety and Efficacy of Daratumumab in the Treatment of Primary Immune Thrombocytopenia Early Phase 1