NCT05852847

Brief Summary

This is a prospective, multicenter, randomized, controlled phase 2 trial to compare the efficacy and safety profiles in ITP patients receiving baricitinib plus danazol to those receiving danazol alone.

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
216

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2023

Geographic Reach
1 country

10 active sites

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 2, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

May 16, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

1.5 years

First QC Date

May 2, 2023

Last Update Submit

June 11, 2023

Conditions

Immune Thrombocytopenia

Keywords

Immune Thrombocytopeniabaricitinib

Outcome Measures

Primary Outcomes (1)

  • Durable response

    The maintenance of a platelet count ≥30,000/μL, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 6-month follow-up.

    6 months

Secondary Outcomes (7)

  • Complete response (CR)

    1 month

  • Response (R)

    1 month

  • Time to response

    6 months

  • Initial response

    28 days

  • Bleeding events

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Low-dose baricitinib plus danazol

EXPERIMENTAL

Oral baricitinib is given at a dose of 2 mg daily for 6 months. Danazol is given at a dose of 200 mg twice a day for 6 months. Treatment will be discontinued if very severe or life-threatening adverse events developed or at the patients' request.

Drug: Baricitinib 2 MG [Olumiant]Drug: Danazol

Danazol

ACTIVE COMPARATOR

Danazol is given at a dose of 200 mg twice a day for 6 months. Treatment will be discontinued if very severe or life-threatening adverse events developed or at the patients' request.

Drug: Danazol

Interventions

Baricitinib 2 MG [Olumiant]DRUG

Oral baricitinib was given at a dose of 2 mg daily for 6 months. Treatment was discontinued if very severe or life-threatening adverse events developed or at the patients' request.

Also known as: Olumiant
Low-dose baricitinib plus danazol
DanazolDRUG

Danazol was given at a dose of 200 mg bid for 6 months

DanazolLow-dose baricitinib plus danazol

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 (\<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;
  • Patients with a platelet count \<30,000/μL or a platelet count \<50,000/μL with clinically significant bleeding symptoms at the enrollment;
  • Willing and able to provide written informed consent, and agreeable to the schedule of assessment.

You may not qualify if:

  • Secondary immune thrombocytopenia (e.g. patients with HIV, HCV, Helicobacter pylori infection or patients with confirmed autoimmune disease);
  • Active or a history of malignancy;
  • Pregnancy or lactation;
  • Current or recent (\<4 weeks prior to screening) clinically serious viral, bacterial, fungal, or parasitic infection;
  • A history of symptomatic herpes zoster infection within 12 weeks prior to screening;
  • Active or chronic viral infection from hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV);
  • Have evidence of active tuberculosis (TB), or have previously had evidence of active TB and did not receive appropriate and documented treatment, or have had household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB;
  • Have experienced a clinically significant thrombotic event within 24 weeks of screening or are on anticoagulants and in the opinion of the investigator are not well controlled;
  • Myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage IV heart failure;
  • A history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data;
  • Any of the following specific abnormalities on screening laboratory tests:
  • \) ALT or AST \>2 x ULN, or total bilirubin ≥1.5 x ULN 2) hemoglobin \<9 g/dL, or total white blood cell (WBC) count \<2,500/µL, or neutropenia (absolute neutrophil count \<1,200/µL), or lymphopenia (lymphocyte count \<750/µL) 3) eGFR \<50 mL/min/1.73 m\^2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

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

Beijing, Beijing Municipality, 100010, China

RECRUITING

Beijing Friendship Hospital

Beijing, China

RECRUITING

Beijing Hospital

Beijing, China

RECRUITING

Beijing Luhe Hospital

Beijing, China

RECRUITING

Beijing Tsinghua Changgeng Hospital

Beijing, China

RECRUITING

China-Japan Friendship Hospital

Beijing, China

RECRUITING

Chinese PLA General Hospital

Beijing, China

RECRUITING

Peking University First Hospital

Beijing, China

RECRUITING

Peking University Third Hospital

Beijing, China

RECRUITING

The Sixth Medical Center of PLA General Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

baricitinibDanazol

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)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Xiaohui Zhang, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohui Zhang, MD

CONTACT

+8610-8832-4672Zhangxh@bjmu.edu.cn

Peng Zhao, MD

CONTACT

+8618810323668zpeng702@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients are randomly assigned at a 1:1 ratio to receive baricitinib plus danazol or danazol alone. Each group requires 108 patients (considering 20% drop-off) to achieve the superiority comparison.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Peking Univeristy Institute of Hematology

Study Record Dates

First Submitted

May 2, 2023

First Posted

May 10, 2023

Study Start

May 16, 2023

Primary Completion

November 1, 2024

Study Completion

May 1, 2025

Last Updated

June 13, 2023

Record last verified: 2023-06

Locations

CN(10)