NCT05943691

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2024

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

July 5, 2023

Last Update Submit

September 24, 2023

Conditions

ITP - Immune Thrombocytopenia

Keywords

Hetrombopag, Dexamethasone

Outcome Measures

Primary Outcomes (1)

  • 26 week sustained overall response to ITP treatments

    Complete response was defined as a platelet count of 100 000 per μL or higher and an absence of bleeding. Partial response was defined as a platelet count of 30000 per μL or higher,and at least a doubling of the baseline platelet count and an absence of bleeding. No response was defined as a platelet count of less than 30000 per μL, or less than two-times increase from baseline platelet count, or bleeding.

    26-week after treatment started

Secondary Outcomes (7)

  • 28-day initial complete response to ITP treatment

    28 days after treatment started]

  • 28-day initial overall response to ITP treatment

    28 days after treatment started

  • 8-week complete response to ITP treatment

    8 weeks after treatment started

  • 8-week overall response to ITP treatment

    8 weeks after treatment started

  • time to response

    an average of 6 months

  • +2 more secondary outcomes

Study Arms (2)

Hetrombopag plus High-dose Dexamethasone

EXPERIMENTAL

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

Drug: hetrombopag 5mg po qdDrug: High-dose Dexamethasone

High-dose Dexamethasone

ACTIVE COMPARATOR

HD-DEX 40mg qd for 4 days

Drug: High-dose Dexamethasone

Interventions

hetrombopag 5mg po qdDRUG

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

Hetrombopag plus High-dose Dexamethasone
High-dose DexamethasoneDRUG

dexamethasone 40 mg qd for 4 days

Hetrombopag plus High-dose DexamethasoneHigh-dose Dexamethasone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shengli Oilfield Central Hospital

Dongying, Shandong, China

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

hetrombopagDexamethasone

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Central Study Contacts

Yan Shi

CONTACT

8682169896shiyansjj@163.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
Professor and Director

Study Record Dates

First Submitted

July 5, 2023

First Posted

July 13, 2023

Study Start

September 15, 2023

Primary Completion

July 10, 2024

Study Completion

December 10, 2024

Last Updated

September 26, 2023

Record last verified: 2023-09

Locations

CN(1)