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

NCT05281068 | Unknown Phase 2 DMC

• 1 other identifier: PKU-ITP030
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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).

Conditions

ITP; Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (5)

• Complete remission

  6 months

• Partial remission

  6 months

• Time to response

  6 months

• Duration of response

  6 months

• Incidence of treatment-emergent adverse events

  6 months

Study Arms (2)

Iguratimod and Danazol

EXPERIMENTAL

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

Drug: Iguratimod; Drug: Danazol

Danazol

ACTIVE COMPARATOR

Danazol is given at 200mg bid for 12 weeks.

Drug: Danazol

Interventions

Iguratimod DRUG

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.

Also known as: Iremod

Iguratimod and Danazol

Danazol DRUG

Oral danazol (200 mg twice daily) for 12 weeks.

Danazol; Iguratimod and Danazol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• years older;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Beijing Hospital: collaborator
• China-Japan Friendship Hospital: collaborator
• Beijing Friendship Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• Shanxi Bethune Hospital: collaborator

Study Sites (2)

Zhuo-Yu An

Beijing, 100044, China

RECRUITING

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

Beijing, China

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

iguratimod; Danazol

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Xiao-Hui Zhang, MD

  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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao-Hui Zhang, MD

CONTACT

15010638916; 1710301242@pku.edu.cn

Zhuo-Yu An, MD

CONTACT

15010638916; anzhuoyu@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Peking University Institute of Hematology

Study Record Dates

• First Submitted: March 6, 2022
• First Posted: March 15, 2022
• Study Start: September 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: December 30, 2023
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

CN (2)