NCT01642979

Brief Summary

Paroxysmal nocturnal hemoglobinuria is an acquired chronic hemolytic anemia,this study is designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in patients with classic paroxysmal nocturnal hemoglobinuria.

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
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2012

Longer than P75 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 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

January 3, 2013

Status Verified

January 1, 2013

Enrollment Period

4 years

First QC Date

July 14, 2012

Last Update Submit

January 1, 2013

Conditions

Paroxysmal Nocturnal HemoglobinuriaHemoglobinuriaHemoglobinuria, ParoxysmalProteinuriaUrination DisordersThrombosisBone Marrow FailureAplastic Anemia,Anemia, Hemolytic

Keywords

Paroxysmal Nocturnal HemoglobinuriaAnemiaHematologic Diseasesbone marrow failureImmunologic FactorsPhysiological Effects of DrugsLevamisolecyclosporine A

Outcome Measures

Primary Outcomes (1)

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

    she got blood transfusion-independent,the hemoglobin became higher

    6 months

Secondary Outcomes (1)

  • Side effects

    6 months

Study Arms (3)

Levamisole+cyclosporin A+Glucocorticoids

EXPERIMENTAL

Levamisole+cyclosporin A+Glucocorticoids

Drug: Levamisole+cyclosporin A+Glucocorticoids

cyclosporin A+Glucocorticoids

ACTIVE COMPARATOR

cyclosporin A+Glucocorticoids

Drug: cyclosporin A+Glucocorticoids

Glucocorticoids

ACTIVE COMPARATOR

Glucocorticoids

Drug: Glucocorticoids

Interventions

Levamisole+cyclosporin A+GlucocorticoidsDRUG

Levamisole 2.5mg/kg every other day cyclosporin A 1.5-2.5mg/kg every other day Glucocorticoids0.5-1mg/kg every day(prednisone)

Also known as: Levamisole, cyclosporin A, Glucocorticoids
Levamisole+cyclosporin A+Glucocorticoids
cyclosporin A+GlucocorticoidsDRUG

cyclosporin A 1.5-2.5mg/kg every day Glucocorticoids0.5-1mg/kg every day(prednisone)

Also known as: cyclosporin A, Glucocorticoids
cyclosporin A+Glucocorticoids
GlucocorticoidsDRUG

Glucocorticoids 0.5-1mg/kg every day(prednisone)

Glucocorticoids

Eligibility Criteria

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

You may qualify if:

  • Clinical and biochemical signs of classic Paroxysmal Nocturnal Hemoglobinuria
  • Diagnosis confirmed by Ham's test or Flow cytometry Patients have any Flow cytometry data
  • patient should complete levamisole study for at least half a year

You may not qualify if:

  • Active infection which requires antibiotic treatment
  • Pregnant or lactating women
  • Epilepsy and mental illness
  • Kidney and liver function abnormal
  • patient who terminate ealy from levamisole study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital,

Tianjin, Tianjin Municipality, 300020, China

Location

Related Publications (1)

  • Parker C, Omine M, Richards S, Nishimura J, Bessler M, Ware R, Hillmen P, Luzzatto L, Young N, Kinoshita T, Rosse W, Socie G; International PNH Interest Group. Diagnosis and management of paroxysmal nocturnal hemoglobinuria. Blood. 2005 Dec 1;106(12):3699-709. doi: 10.1182/blood-2005-04-1717. Epub 2005 Jul 28. No abstract available.

    PMID: 16051736BACKGROUND

Related Links

MeSH Terms

Conditions

Hemoglobinuria, ParoxysmalHemoglobinuriaProteinuriaUrination DisordersThrombosisBone Marrow Failure DisordersAnemia, AplasticAnemia, HemolyticAnemiaHematologic Diseases

Interventions

LevamisoleCyclosporineGlucocorticoids

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesMyelodysplastic SyndromesBone Marrow DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • yizhou zheng, doctor

    Institute of Hematology & Blood Diseases Hospital, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
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

July 14, 2012

First Posted

July 17, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2016

Study Completion

July 1, 2017

Last Updated

January 3, 2013

Record last verified: 2013-01

Locations

CN(1)