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Efficacy and Safety of Iguratimod in the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

Primary Purpose

Immune Thrombocytopenia

Status

Not yet recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Iguratimod

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia

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 30×10^9/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

Peking University Insititute of Hematology, Peking University People's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Iguratimod treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Durable 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.

Secondary Outcome Measures

Initial response

Platelet count ≥ 30 x 10^9/L and at least doubling baseline at 1 month

Remission

109/ Platelet count >100x 10^9/L at 12 mon

Time to response

Time to response was defined as the time from starting treatment to the time to achieve the response

Bleeding

Major bleeding: (1) WHO grade 3 or 4 bleeding, (2) Buchanan severe grade, (3) Bolton-Maggs and Moon "major bleeding," (4) IBLS grade 2 or higher, or (5) life-threatening or intracerebral hemorrhage bleeding

Adverse events

Full Information

NCT ID

NCT05302024

First Posted

March 21, 2022

Last Updated

March 21, 2022

Sponsor

Peking University People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05302024

Brief Title

Efficacy and Safety of Iguratimod in the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

Official Title

Efficacy and Safety of Iguratimod in the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia: a Phase 2, Open-label, Single-arm Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

March 22, 2022 (Anticipated)

Primary Completion Date

December 12, 2023 (Anticipated)

Study Completion Date

December 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A phase 2, open-label, single-arm study to evaluate the efficacy and safety of iguratimod for the treatment of adults with steroid-resistant/relapse immune thrombocytopenia (ITP)

Detailed Description

The investigators are undertaking an open-label, single-arm study of 100 adults with steroid-resistant/ relapse ITP in China. Patients were received Iguratimod treatment. 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

Immune Thrombocytopenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Iguratimod treatment

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Iguratimod

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.

Primary Outcome Measure Information:

Title

Durable 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.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Initial response

Description

Platelet count ≥ 30 x 10^9/L and at least doubling baseline at 1 month

Time Frame

1 month

Title

Remission

Description

109/ Platelet count >100x 10^9/L at 12 mon

Time Frame

12 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

12 months

Title

Bleeding

Description

Time Frame

12 months

Title

Adverse events

Description

Adverse events

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia; Platelet count of less than 30×10^9/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

86-10-88324577

zhangxh@bjmu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Zhuo-Yu An

Phone

15010638916

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University Insititute of Hematology, Peking University People's Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100010

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiao Hui Zhang, doctor

zhangxh100@sina.com

First Name & Middle Initial & Last Name & Degree

Zhuo Yu An, doctor

Phone

+8615010638916

anzhuoyu@pku.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Efficacy and Safety of Iguratimod in the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

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