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The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

Primary Purpose

ITP, Immune Thrombocytopenia

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Iguratimod
Danazol
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ITP

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia;
  • Platelet count of less than 30×109/L at enrollment;
  • Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;
  • 18 years older;

Exclusion Criteria:

  • Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)
  • Congestive heart failure
  • Severe arrhythmia
  • Nursing or pregnant women
  • Aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria
  • Creatinine or serum bilirubin levels each 1•5 times or more than the normal range
  • Active or previous malignancy
  • Unable to do blood routine test for the sake of time, distance, economic issues or other reasons.

Sites / Locations

  • Zhuo-Yu AnRecruiting
  • Peking University Insititute of Hematology, Peking University People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Iguratimod and Danazol

Danazol

Arm Description

Iguratimod is given at a dose of 25 mg bid. Danazol is given at 200mg bid for 12 weeks.

Danazol is given at 200mg bid for 12 weeks.

Outcomes

Primary Outcome Measures

Sustained response
The maintenance of platelet count ≥ 30 x 10^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 6-month follow-up. Interim analysis was scheduled at 50% through recruitment.

Secondary Outcome Measures

Complete remission
The number of participants (responders) with platelet count>=100x10^9/L (CR) and the absence of bleeding.
Partial remission
The number of participants (responders) with platelet count >=30x10^9/L and at least a 2-fold increase in the baseline count (PR) without the administration of any other platelet increasing therapy.
Time to response
Time to response was defined as the time from starting treatment to the time to achieve the response.
Duration of response
Duration of response was measured from the achievement of response to the loss of response.
Incidence of treatment-emergent adverse events
Adverse events were scaled according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Full Information

First Posted
March 6, 2022
Last Updated
April 29, 2022
Sponsor
Peking University People's Hospital
Collaborators
Beijing Hospital, China-Japan Friendship Hospital, Beijing Friendship Hospital, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Chongqing Medical University, Shanxi Bethune Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05281068
Brief Title
The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia
Official Title
The Combination of Iguratimod and Danazol Versus Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia: A Randomized, Controlled, Multicenter, Open-label Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
Collaborators
Beijing Hospital, China-Japan Friendship Hospital, Beijing Friendship Hospital, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Chongqing Medical University, Shanxi Bethune Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Randomized, open-label, multicenter study to compare the efficacy and safety of combination of iguratimod and danazol versus danazol for the treatment of adults with steroid-resistant/ relapse immune thrombocytopenia (ITP).
Detailed Description
The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 100 adults with steroid-resistant/ relapse ITP in China. Patients were randomized to Iguratimod plus danazol and danazol monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ITP, Immune Thrombocytopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Iguratimod and Danazol
Arm Type
Experimental
Arm Description
Iguratimod is given at a dose of 25 mg bid. Danazol is given at 200mg bid for 12 weeks.
Arm Title
Danazol
Arm Type
Active Comparator
Arm Description
Danazol is given at 200mg bid for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Iguratimod
Other Intervention Name(s)
Iremod
Intervention Description
Oral iguratimod (25 mg twice daily) for 12 weeks. Iguratimod is a new drug for the treatment of rheumatoid arthritis (RA) and osteoarthritis (OA), which was filed for marketing in Japan in 2003. It can significantly reduce the inflammatory response, not only selectively inhibit COX-2, but also inhibit the production of inflammatory cytokines, tumor necrosis factor, lymphocytes and immunoglobulins, and has an autoimmunomodulatory effect; it has a rapid onset of action, better efficacy and fewer adverse effects than existing drugs, and is effective in patients for whom other drugs are ineffective. It has been reported in the literature that in vitro iguratimod can inhibit the activity of nuclear factor-κB (NF-κB), which in turn inhibits the production of inflammatory cytokines (interleukin-1, interleukin-6, interleukin-8, tumor necrosis factor alpha). Iguratimod also interacts directly with mouse and human B cells in vitro to inhibit the production of immunoglobulins.
Intervention Type
Drug
Intervention Name(s)
Danazol
Intervention Description
Oral danazol (200 mg twice daily) for 12 weeks.
Primary Outcome Measure Information:
Title
Sustained response
Description
The maintenance of platelet count ≥ 30 x 10^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 6-month follow-up. Interim analysis was scheduled at 50% through recruitment.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Complete remission
Description
The number of participants (responders) with platelet count>=100x10^9/L (CR) and the absence of bleeding.
Time Frame
6 months
Title
Partial remission
Description
The number of participants (responders) with platelet count >=30x10^9/L and at least a 2-fold increase in the baseline count (PR) without the administration of any other platelet increasing therapy.
Time Frame
6 months
Title
Time to response
Description
Time to response was defined as the time from starting treatment to the time to achieve the response.
Time Frame
6 months
Title
Duration of response
Description
Duration of response was measured from the achievement of response to the loss of response.
Time Frame
6 months
Title
Incidence of treatment-emergent adverse events
Description
Adverse events were scaled according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia; Platelet count of less than 30×109/L at enrollment; Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation; 18 years older; Exclusion Criteria: Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus) Congestive heart failure Severe arrhythmia Nursing or pregnant women Aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria Creatinine or serum bilirubin levels each 1•5 times or more than the normal range Active or previous malignancy Unable to do blood routine test for the sake of time, distance, economic issues or other reasons.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao-Hui Zhang, MD
Phone
15010638916
Email
1710301242@pku.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhuo-Yu An, MD
Phone
15010638916
Email
anzhuoyu@pku.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao-Hui Zhang, MD
Organizational Affiliation
Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhuo-Yu An
City
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhuo-Yu An
Phone
15010638916
Email
anzhuoyu@pku.edu.cn
Facility Name
Peking University Insititute of Hematology, Peking University People's Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao-hui Zhang, Professor
Email
zhangxh100@sina.com

12. IPD Sharing Statement

Learn more about this trial

The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

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