NCT03918265

Brief Summary

Autoimmune cytopenia, including autoimmune hemolytic anemia (AIHA), pure red cell aplasia (PRCA), Evans syndrome (ES), usually has good responses to steroids therapies as first line, but there is a considerable percentage of patients who relapse, become refractory or dependent on steroids to maintain an acceptable level of hemoglobin or platelets. The effects of the second line therapy are also not satisfactory and sometimes not available. The investigators aim to explore the efficacy and side-effect of tacrolimus for refractory autoimmune cytopenia.

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
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2019

Typical duration for phase_4

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

April 16, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

May 4, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2021

Completed
Last Updated

December 3, 2019

Status Verified

June 1, 2019

Enrollment Period

1.3 years

First QC Date

April 16, 2019

Last Update Submit

December 1, 2019

Conditions

Autoimmune Hemolytic AnemiaPure Red Cell AplasiaEvans Syndrome

Keywords

TacrolimusRefractory autoimmune cytopeniaProspective study

Outcome Measures

Primary Outcomes (2)

  • Hemoglobin level

    Hemoglobin level in g/L

    6 months

  • Platelet count

    Platelet count in /L

    6 months

Secondary Outcomes (2)

  • Hemoglobin level

    2 years

  • Platelet count

    2 years

Study Arms (1)

Efficiency of tacrolimus on autoimmune cytopenia

EXPERIMENTAL

A prospective research of the tacrolimus efficiency on refractory autoimmune cytopenia patients. Dosage: 1mg bid and tacrolimus trough targets were 5-10 ng/ml throughout the study. Medication time should last at least 6 months.

Drug: Tacrolimus

Interventions

TacrolimusDRUG

On refractory autoimmune cytopenia patients, tacrolimus was tried. Dosage: 1mg bid and tacrolimus trough targets were 5-10 ng/ml throughout the study

Also known as: tacrolimus capsule
Efficiency of tacrolimus on autoimmune cytopenia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Refractory autoimmune cytopenia, including autoimmune hemolytic anemia, pure red cell aplasia, Evans syndrome.
  • years old.
  • No response or intolerant to first and second line therapies.
  • ECOG Performance Status of 0-2
  • Written informed consent.

You may not qualify if:

  • Other diseases which might cause hematological abnormalities.
  • Response and well tolerate to first or second line therapy.
  • Patients who are under 18-year-old or over 80-year-old.
  • Pregnant or lactating.
  • Patients unwilling to or unable to comply with the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (2)

  • Li Y, Feng X. Efficacy and safety of tacrolimus in systemic lupus erythematosus patients with refractory thrombocytopenia: a retrospective study. Lupus. 2018 Jan;27(1):60-65. doi: 10.1177/0961203317711011. Epub 2017 May 31.

    PMID: 28566017BACKGROUND

  • Tabchi S, Hanna C, Kourie HR, Aftimos P, El Osta L, Ghosn M. Successful treatment of Evans syndrome with Tacrolimus. Invest New Drugs. 2015 Feb;33(1):254-6. doi: 10.1007/s10637-014-0155-9. Epub 2014 Sep 12. No abstract available.

    PMID: 25209619BACKGROUND

MeSH Terms

Conditions

Anemia, Hemolytic, AutoimmuneRed-Cell Aplasia, PureEvans Syndrome

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Anemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Bing Hang, PhD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruoxi Zhang, M.D.

CONTACT

+86 18510064839rx_zh15@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2019

First Posted

April 17, 2019

Study Start

May 4, 2019

Primary Completion

August 10, 2020

Study Completion

November 10, 2021

Last Updated

December 3, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)