NCT01579110

Brief Summary

The purpose of this study is to determine whether Levamisole plus prednisone can further improve the efficacy，extend the remission duration and reduce the dosage of prednisone for newly diagnosed warm antibody autoimmune hemolytic anemia.

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 Apr 2012

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

Study Start

First participant enrolled

April 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 19, 2012

Status Verified

April 1, 2012

Enrollment Period

3 years

First QC Date

April 13, 2012

Last Update Submit

April 18, 2012

Conditions

AnemiaAnemia, HemolyticAnemia, Hemolytic, AutoimmuneHemolysisHematologic DiseasesAutoimmune DiseasesImmune System DiseasesPathologic Processes

Keywords

autoimmune hemolytic anemiahemolytic anemiaLevamisoleTreatment of autoimmune hemolytic anemiawarm antibody dependant autoimmune hemolytic anemia

Outcome Measures

Primary Outcomes (1)

  • Number of patients in each group in complete or partial remission

    one year

Secondary Outcomes (1)

  • Side effects

    1year

Study Arms (2)

prednisolone + levamisole

EXPERIMENTAL
Drug: levamisole

Prednisone

ACTIVE COMPARATOR
Drug: Prednisone

Interventions

levamisoleDRUG

Levamisole 2.5mg/kg(every other day) over six months. Prednisone 1mg/kg for two weeks and then tapered off dosage over two months.

prednisolone + levamisole
PrednisoneDRUG

Prednisone 1mg/kg for two weeks and then tapered off dosage over two months.

Prednisone

Eligibility Criteria

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

You may qualify if:

  • Clinical and biochemical signs of hemolytic anaemia
  • Positive Coombs test with anti-IgG or and with anti-CD3d
  • Newly diagnosed Warm Autoimmune Hemolytic Anemia
  • Adequate contraceptive measures for women of childbearing potential
  • informed consent signed

You may not qualify if:

  • Active infection which requires antibiotic treatment
  • Pregnant or lactating women
  • Epilepsy and mental illness
  • Kidney and liver function abnormal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

Location

MeSH Terms

Conditions

AnemiaAnemia, HemolyticAnemia, Hemolytic, AutoimmuneHemolysisHematologic DiseasesAutoimmune DiseasesImmune System DiseasesPathologic Processes

Interventions

LevamisolePrednisone

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Yizhou Zheng, doctor

    Blood Diseases Hospital Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

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 director of the therapeutic centre of anemic diseases

Study Record Dates

First Submitted

April 13, 2012

First Posted

April 17, 2012

Study Start

April 1, 2012

Primary Completion

April 1, 2015

Study Completion

April 1, 2016

Last Updated

April 19, 2012

Record last verified: 2012-04

Locations

CN(1)