NCT04481282

Brief Summary

Single-arm, open-label, single center study to assess the efficacy and safety of terbutaline plus danazol in patients with corticosteroid resistant/relapsed 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
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2020

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

Study Start

First participant enrolled

July 8, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

9 months

First QC Date

July 19, 2020

Last Update Submit

July 21, 2020

Conditions

Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

  • Sustained response

    The maintenance of platelet count ≥ 30 x 10\^9/L, 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. Interim analysis was scheduled at 50% through recruitment.

    6 months

Secondary Outcomes (5)

  • complete remission

    6 months

  • partial remission

    6 months

  • time to response

    6 months

  • duration of response

    6 months

  • incidence of treatment-emergent adverse events

    6 months

Study Arms (1)

Terbutaline plus Danazol group

EXPERIMENTAL

Terbutaline 2.5mg tid po plus danazol 200mg bid po for 12weeks

Drug: TerbutalineDrug: Danazol

Interventions

TerbutalineDRUG

2.5mg po tid for 12 weeks

Also known as: Bricanyl Brethine
Terbutaline plus Danazol group
DanazolDRUG

200mg po bid for 12 weeks

Also known as: Danocrine, Cleregil, Danol
Terbutaline plus Danazol group

Eligibility Criteria

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

You may qualify if:

  • ITP confirmed by excluding other supervened causes of thrombocytopenia;
  • Platelet count of less than 30×10\^9/L at enrollment;
  • 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;
  • Subject has signed and dated written informed consent.
  • Fertile patients must use effective contraception during treatment and observational period
  • Negative pregnancy test.

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.
  • diagnosis with any of the following diseases: chronic hypertension, hyperthyroidism, diabetes, or seizure 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

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

TerbutalineDanazoldeanol aceglutamate

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)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Xiaohui Zhang, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohui Zhang, MD

CONTACT

010-88324981zhangxh100@sina.com

Gaochao Zhang, phD

CONTACT

+8618053803755zhanggaochao0210@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Peking Univeristy Institute of Hematology

Study Record Dates

First Submitted

July 19, 2020

First Posted

July 22, 2020

Study Start

July 8, 2020

Primary Completion

March 31, 2021

Study Completion

July 31, 2021

Last Updated

July 22, 2020

Record last verified: 2020-07

Locations

CN(1)