High-dose Dexamethasone Plus Hetrombopag vs High-dose Dexamethasone Alone as Frontline Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Prospective, Multicenter, Randomized Trial

NCT ID: NCT05943691

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2024-12-10

Brief Summary

The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of Hetrombopag plus high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).

Detailed Description

The investigators anticipate to undertaking a parallel group, randomised controlled trial of 100 ITP patients. One part of the participants are randomly selected to receive hetrombopag with starting dose 5mg po qd for 8 weeks（increase daily dose to a maximum of 7.5 mg/day if platelet count<50000 per μL following at least 2 weeks of treatment) combining with dexamethasone (given at a dose of 40 mg qd for 4 consecutive days). The others are selected to receive high-dose of dexamethasone alone. Patients who do not respond to dexamethasone may receive another cycle of high-dose dexamethasone therapy within 2 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. The purpose of this study is to report the efficacy and safety of Hetrombopag combining with high-dose dexamethasone therapy for the treatment of newly diagnosed ITP.

Conditions

ITP - Immune Thrombocytopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hetrombopag plus High-dose Dexamethasone

Hetrombopag 5mg po qd; HD-DEX 40mg qd for 4 days

Group Type: EXPERIMENTAL

hetrombopag 5mg po qd

Intervention Type: DRUG

hetrombopag 5mg po qd for 8 weeks, combining with dexamethasone 40 mg qd for 4 days

High-dose Dexamethasone

Intervention Type: DRUG

dexamethasone 40 mg qd for 4 days

High-dose Dexamethasone

HD-DEX 40mg qd for 4 days

Group Type: ACTIVE_COMPARATOR

High-dose Dexamethasone

Intervention Type: DRUG

dexamethasone 40 mg qd for 4 days

Interventions

hetrombopag 5mg po qd

hetrombopag 5mg po qd for 8 weeks, combining with dexamethasone 40 mg qd for 4 days

Intervention Type: DRUG

High-dose Dexamethasone

dexamethasone 40 mg qd for 4 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Older than 18 years
• Meet the diagnostic criteria for newly diagnosed immune thrombocytopenia (diagnosed within 3 month);
• platelet count <30*10^9/L, or < 50*10^9/L with bleeding manifestations, both;
• Willing and able to sign written informed consent

Exclusion Criteria

• secondary thrombocytopenia or graded MF≥2 myelofbrosis based on the European Consensus Scale
• Previous history of treatment for ITP, except Platelet transfusion, ITP-directed Prednisone therapy no more than 2 weeks or TPO therapy no more than 1 week and stopped ≥1 week before randomization
• No response to TPO-RA or rhTPO
• HIV, hepatitis C or B virus infection
• pregnancy or lactation;
• arterial or venous thromboembolism within the 6 months before screening
• total bilirubinalanine, aminotransferase or aspartate transaminase>3×upper limit of normal (ULN), serum creatinine>1.5×ULN
• congestive heart failure (New York Heart Association [NYHA] class III/IV);
• neoplastic disease within the past 5 years;
• liver cirrhosis
• people who could not adhere to the protocol or were planning to have a surgical procedure in 6 months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Ming Hou

Professor and Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shengli Oilfield Central Hospital

Dongying, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yan Shi

Role: CONTACT

shiyansjj@163.com

8682169896

Facility Contacts

Liang Wang, MD

Role: primary

18654620224

Other Identifiers

ITP-Hetrombopag plus HD-DEX

Identifier Type: -

Identifier Source: org_study_id