Glycyrrhetinic Acid Combined With Dexamethasone in Management of Newly Diagnosed ITP

NCT03998982 | Unknown Phase 4

• 1 other identifier: Glycyrrhetinic Acid+DXM in ITP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Immune Thrombocytopenia

Keywords

ITP；glycyrrhetinic acid；dexamethasone

Outcome Measures

Primary Outcomes (1)

• Sustained response to ITP treatments

  Percentage of patients maintaining PLT count over 30\*10\^9 without bleeding

  3 months after treatment started

Secondary Outcomes (1)

• Evaluation of platelet response

  3 months after treatment started

Study Arms (2)

glycyrrhetinic acid Combining HD-DXM

ACTIVE COMPARATOR

Compound glycyrrhizin tablets 75mg three times per day, 1 month, and HD-DXM (orally at 40 mg daily for 4d )

Drug: Glycyrrhetinic Acid; Drug: Dexamethasone

HD-DXM

ACTIVE COMPARATOR

HD-DXM (orally at 40 mg daily for 4d )

Drug: Dexamethasone

Interventions

Glycyrrhetinic Acid DRUG

Compound glycyrrhizin tablets 75 mg three times per day, 1 month

glycyrrhetinic acid Combining HD-DXM

Dexamethasone DRUG

HD-DXM (orally at 40 mg daily for 4d)

HD-DXM; glycyrrhetinic acid Combining HD-DXM

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the diagnostic criteria for immune thrombocytopenia;
• Untreated hospitalized patients, may be male or female, between the ages of 18\~ 80 years;
• To show a platelet count \<30 \* 10\^9/L, and with bleeding manifestations;
• Willing and able to sign written informed consent

You may not qualify if:

• Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit;
• Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit;
• Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study;
• Current HIV infection;
• Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac
• Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period;
• Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;
• Patients who are deemed unsuitable for the study by the investigator.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Glycyrrhetinic Acid; Dexamethasone

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)

Pentacyclic Triterpenes; Triterpenes; Terpenes; Hydrocarbons; Organic Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Ming Hou, MD,PhD

  Shandong University Qilu Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Hou, MD,PhD

CONTACT

+86-531-82169114 Ext. 9879; houming@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: June 26, 2019
• Study Start: June 25, 2019
• Primary Completion: June 10, 2021
• Study Completion: June 10, 2021
• Last Updated: June 11, 2021

Record last verified: 2021-06

Locations

CN (1)