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

NCT05353673 | Unknown Phase 2 DMC

• 1 other identifier: PKU-ITP035
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, open-label, multicenter study to compare the efficacy and safety of combination of Sitagliptin and danazol versus danazol for the treatment of adults with steroid-resistant/relapse immune thrombocytopenia (ITP).

Conditions

Immune Thrombocytopenia; Blood Coagulation Disorders; Thrombocytopenia; Physiological Effects of Drugs

Keywords

Sitagliptin; Immune Thrombocytopenia; Danazol

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)

Sitagliptin and Danazol

EXPERIMENTAL

Sitagliptin is given at a dose of 100 mg/m2 qd for 12 weeks. Danazol is given at 200mg bid for 12 weeks.

Drug: Sitagliptin; Drug: Danazol

Danazol

ACTIVE COMPARATOR

Danazol is given at 200mg bid for 12 weeks.

Drug: Danazol

Interventions

Sitagliptin DRUG

Oral Sitagliptin (100mg/m2 daily) for 12 weeks. DPP4 inhibitors have anti-inflammatory, immunomodulatory, and hematopoietic effects in addition to their glycemic regulatory effects. In vivo experiments found that endogenous DPP-4 inhibits megakaryopoiesis, and knockout or inhibition of DPP4 in vivo can enhance the recovery of hematopoietic function after stress. The loss of DPP-4 activity in DPP-4-/-mice mice resulted in an expansion of the megakaryocyte progenitor population in vivo, the recovery time of platelets was shorter than in normal mice after platelet depletion with anti-mouse CD41 antibody. Compared with ordinary mice, the number of platelets increased, which provides a theoretical basis for the use of DPP-4 inhibitors in patients with ITP, and has potential clinical significance.

Also known as: JANUVIA

Sitagliptin and Danazol

Danazol DRUG

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

Also known as: Danocrine

Danazol; Sitagliptin 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; 18 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

Study Sites (1)

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

Beijing, Beijing Municipality, 100010, China

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Blood Coagulation Disorders; Thrombocytopenia

Interventions

Sitagliptin Phosphate; Danazol

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; 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)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Xiao-hui Zhang, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao-Hui Zhang, Professor

CONTACT

+8613522338836; zhangxh100@sina.com

Jin Wu, MD

CONTACT

+8617888838056; wujin1996@126.com

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 Univeristy Institute of Hematology

Model Details: 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 Sitagliptin 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.

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: April 29, 2022
• Study Start: June 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: February 1, 2023
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

CN (1)