NCT05369377

Brief Summary

Randomized, open-label, multicenter study to compare the efficacy and safety of zanubrutinib plus eltrombopag compared to eltrombopag monotherapy for the first-line treatment of adults with chronic 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
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2022

Typical duration 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

May 6, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

3 years

First QC Date

May 6, 2022

Last Update Submit

May 6, 2022

Conditions

Immune Thrombocytopenia

Keywords

BTK inhibitorThrombopoietin-receptor agonist

Outcome Measures

Primary Outcomes (1)

  • Treatment response

    The proportion of patients who had an increase in platelet counts to 50 000 per μL or more after 6 weeks of treatment

    6 weeks

Secondary Outcomes (8)

  • Overall response

    6 weeks

  • Complete response (CR)

    6 weeks

  • Time to response

    6 weeks

  • Sustained response

    12 month

  • Number of patients with bleeding

    12 months

  • +3 more secondary outcomes

Study Arms (2)

Zanubrutinib and eltrombopag

EXPERIMENTAL

Zanubrutinib 80mg po qd 6 weeks and eltrombopag 50 mg qd for up to 6 weeks.

Drug: ZanubrutinibDrug: Eltrombopag

Eltrombopag monotherapy

ACTIVE COMPARATOR

Eltrombopag is given as 50 mg qd for up to 6 weeks.

Drug: Eltrombopag

Interventions

ZanubrutinibDRUG

Zanubrutinib 80mg po qd 6 weeks

Also known as: BTK inihibitor
Zanubrutinib and eltrombopag
EltrombopagDRUG

eltrombopag 50 mg qd for up to 6 weeks. The eltrombopag dose could be increased from 50 mg to 75 mg after 3 weeks in patients whose platelet counts were less than 50 000 per μL. Treatment was discontinued in patients who attained a platelet count greater than 200 000 per μL.

Eltrombopag monotherapyZanubrutinib and eltrombopag

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia;
  • Patients with chronic low platelet count (less than 30,000/µL) for 6 months who have failed at least one treatment for chronic low platelet count
  • \. 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 3. Willing and able to sign written informed consent

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
  • History of clotting disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, Beijing Municipality, 100010, China

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

zanubrutinibeltrombopag

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

Study Officials

  • Xiaohui Zhang, md

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohui Zhang, MD

CONTACT

+8613522338836zhangxh100@sina.com

Qiusha Huang, MD

CONTACT

+8613051816058huangfuqs@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
Vice president of Peking Univeristy Institute of Hematology

Study Record Dates

First Submitted

May 6, 2022

First Posted

May 11, 2022

Study Start

June 1, 2022

Primary Completion

June 1, 2025

Study Completion

December 30, 2025

Last Updated

May 11, 2022

Record last verified: 2022-05

Locations

CN(1)