A Multicenter Randomized Open-label Study of Diammonium Glycyrrhizinate Enteric-coated Capsule Plus DXM Versus DXM in Treatment of ITP

Sponsor
Shandong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05023915
Collaborator
(none)
106
2
2
11.3
53
4.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

The investigators anticipate to undertaking a parallel group, randomised controlled trial of 106 ITP patients. One part of the participants are randomly selected to receive diammonium glycyrrhizinate enteric-coated capsule orally at a dose of 150mg tid for 3 months), combining with dexamethasone (given orally at a dose of 40 mg qd for 4 days). The others are selected to receive high-dose of dexamethasone alone. Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days. 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 diammonium glycyrrhizinate enteric-coated capsule combining with high-dose dexamethasone therapy for the treatment of ITP.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
106 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
High-dose Dexamethasone Plus Diammonium Glycyrrhizinate Enteric-coated Capsule Versus High-dose Dexamethasone in Treatment-naive Primary Immune Thrombocytopenia (ITP): a Multicentre, Randomised, Open-label Trial
Anticipated Study Start Date :
Aug 21, 2021
Anticipated Primary Completion Date :
Aug 21, 2021
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: diammonium glycyrrhizinate enteric-coated capsule + high-dose dexamethasone

Diammonium glycyrrhizinate enteric-coated capsule orally at a dose of 150mg tid for 3 months, combining with dexamethasone (given orally at a dose of 40 mg qd for 4 days). Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days.

Drug: dexamethasone
40 mg qd for 4 days

Drug: diammonium glycyrrhizinate enteric-coated capsule
150mg tid for 3 months

Active Comparator: High-dose dexamethasone

Dexamethasone orally at a dose of 40 mg qd for 4 days. Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days.

Drug: dexamethasone
40 mg qd for 4 days

Outcome Measures

Primary Outcome Measures

  1. 14-day initial overall response to ITP treatments [14 days after treatment started]

    Complete response was defined as a platelet count of 100×10⁹ cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10⁹ cells per L or higher, but less than 100×10⁹ cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding. Platelet counts were confirmed on two separate occasions at least 7 days apart when defining complete response or partial response. No response was defined as a platelet count of less than 30×10⁹ cells per L, or less than two-times increase from baseline platelet count, or bleeding.

  2. 6-month sustained overall response to ITP treatments [A response lasting for at least 6 months without any additional intervention specific to primary immune thrombocytopenia was defined as a sustained response]

    Complete response was defined as a platelet count of 100×10⁹ cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10⁹ cells per L or higher, but less than 100×10⁹ cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding. Platelet counts were confirmed on two separate occasions at least 7 days apart when defining complete response or partial response. No response was defined as a platelet count of less than 30×10⁹ cells per L, or less than two-times increase from baseline platelet count, or bleeding.

Secondary Outcome Measures

  1. time to response [an average of 6 months]

    the time from treatment initiation to achieve a complete response or a partial response

  2. duration of response [through study completion, an average of one year]

    the time from achievement of a complete response or a partial response to the loss of response (platelet count <30×10⁹ cells per L; measured on two occasions more than 1 day apart or the presence of bleeding).

  3. therapy associated adverse events [up to one year]

    nausea and diarrhea (report in frequency); pruritus (report in frequency); headache and dizziness (report in frequency)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Meet the diagnostic criteria for immune thrombocytopenia;

  • Untreated hospitalized patients or patients from the clinic, may be male or female, between the ages of 18~ 80 years;

  • To show a platelet count <30 * 10^9/L, or with bleeding manifestations, or both;

  • Willing and able to sign written informed consent

  • ITP patients with hepatitis virus infection or ITP patients with abnormal liver function at the time of enrollment, i.e., ITP patients with indications for diammonium glycyrrhizinate enteric-coated capsule, should be separately stratified.

Exclusion Criteria:
  • secondary thrombocytopenia;

  • severe immune-deficiency;

  • active or previous malignancy;

  • HIV virus infection, tuberculosis, or other active infection (sepsis, pneumonia, or abscess);

  • pregnancy or lactation;

  • diabetes;

  • hypertension;

  • cardiovascular diseases;

  • severe kidney function impairment;

  • psychosis;

  • osteoporosis;

  • inflammatory bowel disease or gastric disease;

  • arterial or venous thromboembolism within the 6 months before screening or patients who required anticoagulant treatment;

  • an organ or haematopoietic stem-cell transplantation;

  • neutrophil count of less than 1500 cells per mm³;

  • glycosylated haemoglobin less than 8%;

  • partial thromboplastin time 1∙5 times or less the upper limit of normal (ULN); •clinical electrocardiogram changes;

  • history of primary immunodeficiency;

  • neoplastic disease within the past 5 years;

  • corrected QT interval greater than 450 ms for men and greater than 470 ms for women;

  • substance misuse within the previous 12 months;

  • people who could not adhere to the protocol or were planning to have a surgical procedure in 6 months.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Qilu hospital, Shandong University Jinan Shandong China 250000
2 Qilu hospital (Qingdao), Shandong University Qingdao Shandong China 266000

Sponsors and Collaborators

  • Shandong University

Investigators

  • Principal Investigator: Ming Hou, MD,PhD, Shandong University Qilu Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ming Hou, Professor and Director, Shandong University
ClinicalTrials.gov Identifier:
NCT05023915
Other Study ID Numbers:
  • ITP-Diammonium Glycyrrhizinate
First Posted:
Aug 27, 2021
Last Update Posted:
Aug 27, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ming Hou, Professor and Director, Shandong University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 27, 2021