deltatrials
Unknown PHASE2 INTERVENTIONAL 3-arm NCT01760096

Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the Setting of Another Bone Marrow Failure Syndromes(PNH-2013)

Phase II Study of the Levamisole Combined With Cyclosporine A in Patients With Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the Setting of Another Bone Marrow Failure Syndromes(PNH-2013)

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Updated 8 times since 2017 Last updated: Jan 1, 2013 Started: Jan 31, 2013 Primary completion: Jul 31, 2016 Completion: Jul 31, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01760096, this PHASE2 trial focuses on Anemia, Hemolytic and Aplastic Anemia, and remains ongoing. Sponsored by Institute of Hematology & Blood Diseases Hospital, China, it has been updated 8 times since 2013, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

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 Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the setting of another bone marrow failure syndromes

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 Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the setting of another bone marrow failure syndromes

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotActive Not Recruiting~Feb 2017 – ~Aug 2017 · 6 months · monthly snapshotActive Not Recruiting~Aug 2017 – ~Jan 2021 · 41 months · monthly snapshotUnknown Status~Jan 2021 – ~Oct 2023 · 33 months · monthly snapshotUnknown Status~Oct 2023 – ~Jul 2024 · 9 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – present · 19 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

8 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown PHASE2

  2. Sep 2024 — Present [monthly]

    Unknown PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE2

    Status: Unknown StatusUnknown

  4. Oct 2023 — Jul 2024 [monthly]

    Unknown Status PHASE2

  5. Jan 2021 — Oct 2023 [monthly]

    Unknown Status PHASE2

Show 3 earlier versions
  1. Aug 2017 — Jan 2021 [monthly]

    Unknown Status PHASE2

    Status: Active Not RecruitingUnknown Status

  2. Feb 2017 — Aug 2017 [monthly]

    Active Not Recruiting PHASE2

  3. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE2

    First recorded

Jan 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Institute of Hematology & Blood Diseases Hospital, China
Data source: Institute of Hematology & Blood Diseases Hospital, China

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations