Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05494307
Other study ID # PKU-ITP039
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date September 1, 2022
Est. completion date February 28, 2024

Study information

Verified date August 2022
Source Peking University People's Hospital
Contact Ye-Jun Wu, MD
Phone 13522338836
Email wyejun1999@pku.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized, open-label, multicenter study to compare the efficacy and safety of terbutaline plus danazol compared to danazol monotherapy for the second-line treatment of adults with corticosteroid-resistant or relapsed primary immune thrombocytopenia (ITP).


Description:

The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 228 adults with ITP in China. Patients were randomized to terbutaline plus danazol compared to danazol monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 228
Est. completion date February 28, 2024
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: Patients >18 years old with corticosteroid-resistant or relapsed ITP who had either a platelet count of <30×10^9/L or a platelet count of <50×10^9/L and clinically significant bleeding. 1. Not achieving a sustained response to therapy with full-dose corticosteroids for a duration of at least 4 weeks or relapsed during the process of corticosteroid tapering or discontinuation; 2. Platelet counts <30×10^9/L or platelet counts < 50×10^9/L and significant bleeding symptoms (WHO bleeding scale 2 or above); 3. Willing and able to sign written informed consent. Exclusion Criteria: 1. Pregnant or lactating women; 2. Secondary ITP (have a known diagnosis of connective tissue diseases, malignancy, active infection, HIV infections or hepatitis B virus or hepatitis C virus infections); 3. Received drugs affecting the platelet counts within 6 months before the screening visit (e.g., chemotherapy, anticoagulants, etc); 4. Severe medical condition (lung, heart, hepatic or renal disorder); 5. Patients who are deemed unsuitable for the study by the investigator. 6. Patients who had hypertension, diabetes mellitus, hyperthyroidism or coronary heart disease.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Terbutaline
Orally terbutaline at a dose of 2.5 mg three times daily for 16 weeks
Danazol
Orally danazol at a dose of 200 mg twice daily for 16 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Peking University People's Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Overall response Achieving a platelet count = 30 × 10^9/L confirmed on at least two separate occasions (at least 7 days apart), at least a doubling of the baseline platelet count without any other ITP-specific treatment and the absence of bleeding. From date of randomization until 1 years or the end of follow-up
Secondary Sustained response maintenance of a platelet count > 30 × 10^9/L, an absence of bleeding, and no requirement for any other ITP-specific treatment for 6 consecutive months after achievement of OR From date of randomization until 1 years or the end of follow-up
Secondary Complete response a platelet count = 100 × 10^9/L measured on two occasions at least 7 days apart and the absence of bleeding From date of randomization until 1 years or the end of follow-up
Secondary Remission a durable platelet count > 30 × 109/L without bleeding up to 12 months after randomization at 12-month follow-up
Secondary Time to response the time from starting treatment to the time a response was achieved. From date of randomization until 1 years or the end of follow-up
Secondary Duration of response time from OR until loss of response or until the last follow-up visit From date of randomization until 1 years or the end of follow-up
Secondary Rescue therapy any new medical intervention taken to increase the platelet count or prevent bleeding events or an increase in the dose of concomitant treatments From date of randomization until 1 years or the end of follow-up
Secondary Associated factors of treatment failure, OR, SR and remission Factors that are associated with treatment failure, OR, SR and remission From date of randomization until 1 years or the end of follow-up
Secondary Number of patients with bleeding Number of patients with bleeding complication (WHO bleeding score) From date of randomization until 1 years or the end of follow-up
Secondary Number of patients with side effects Number of patients with Medication adverse events. From date of randomization until 1 years or the end of follow-up
Secondary Relapse Loss of OR From date of randomization until 1 years or the end of follow-up
Secondary Relapse-free survival the time interval between achievement of OR and relapse or the end of the follow-up From date of randomization until 1 years or the end of follow-up
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 NCT02868099 - Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP) Phase 3
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 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 NCT05468866 - The Expression of Immune Checkpoint CD28 rs1980422-related Single-nucleotide Polymorphisms in the Primary Immune Thrombocytopenia N/A
Recruiting NCT04993885 - Avatrombopag in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies Phase 2
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