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Status unknownNCT01642979PNH-2012Updated Jan 3, 2013

Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria

A Phase 2 interventional study of Levamisole+cyclosporin A+Glucocorticoids and cyclosporin A+Glucocorticoids in Paroxysmal Nocturnal Hemoglobinuria, Hemoglobinuria and Hemoglobinuria, Paroxysmal, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-03.

Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2013), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired clonal disorder of the hematopoietic stem cell characterized by intravascular hemolysis, hemoglobinuria, anemia, and thrombosis, Patients may be at high risk of thrombosis and may develop bone marrow failure or aplastic anemia, with low white blood cell and platelet counts,because the manifestation and pathologic processes are complicate,the treatment is very difficult,this study is designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in patients with classic paroxysmal nocturnal hemoglobinuria

02

Conditions studied

  • Paroxysmal Nocturnal Hemoglobinuria
  • Hemoglobinuria
  • Hemoglobinuria, Paroxysmal
  • Proteinuria
  • Urination Disorders
  • Thrombosis
  • Bone Marrow Failure
  • Aplastic Anemia,
  • Anemia, Hemolytic

Keywords

  • Paroxysmal Nocturnal Hemoglobinuria
  • Anemia
  • Hematologic Diseases
  • bone marrow failure
  • Immunologic Factors
  • Physiological Effects of Drugs
  • Levamisole
  • cyclosporine A
03

In context

Proteinuria

234 studies on the registry are indexed under Proteinuria; 43 are open to participants now.

This study's planned enrollment of 120 is above the median of 60 across 164 interventional studies indexed under Proteinuria.

Browse Proteinuria studies →

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 398 studies on the registry; 293 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Active infection which requires antibiotic treatment
  2. Pregnant or lactating women
  3. Epilepsy and mental illness
  4. Kidney and liver function abnormal
  5. patient who terminate ealy from levamisole study
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Levamisole+cyclosporin A+Glucocorticoids

    Levamisole+cyclosporin A+Glucocorticoids

    Drug: Levamisole+cyclosporin A+Glucocorticoids

  • Active comparator
    cyclosporin A+Glucocorticoids

    cyclosporin A+Glucocorticoids

    Drug: cyclosporin A+Glucocorticoids

  • Active comparator
    Glucocorticoids

    Glucocorticoids

    Drug: Glucocorticoids

Interventions

  • DrugLevamisole+cyclosporin A+Glucocorticoids

    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

  • Drugcyclosporin A+Glucocorticoids

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

    Also known as: cyclosporin A, Glucocorticoids

  • DrugGlucocorticoids

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

06

What researchers measure

Primary outcomes

  1. Number of patients in each group in complete or partial remission

    she got blood transfusion-independent,the hemoglobin became higher

    Time frame: 6 months

Secondary outcomes

  1. Side effects

    Time frame: 6 months

07

Study locations

1 site
  • Institute of Hematology & Blood Diseases Hospital,
    Tianjin, Tianjin 300020, China
08

References and documents

Publications

  • 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. PubMed 16051736 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01642979
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
Responsible party
Yizhou Zheng (Vice director of the therapeutic centre of anemic diseases, Institute of Hematology & Blood Diseases Hospital, China) — Principal investigator
First posted
Jul 17, 2012
Start date
Jul 2012
Primary completion
Jul 2016 (estimated)
Completion
Jul 2017 (estimated)
Last update
Jan 3, 2013

Study contacts

yizhou zheng, doctor
principal investigator · Institute of Hematology & Blood Diseases Hospital, China

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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