問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol Number20150168

2019-01-22 - 2022-07-12

Phase III

Recruiting3

ICD-10R82.3

Hemoglobinuria

ICD-9791.2

Hemoglobinuria

A Randomized, Double-blind, Active-controlled, Phase 3 Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)

  • Trial Applicant

    Pharmaceutical Research Associates Taiwan Inc.

  • Sponsor

    Amgen Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 蕭聖諺 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 沈銘鏡 Division of Hematology & Oncology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hui-Hua Hsiao 無
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Objectives

This is a randomized, double-blind, active-controlled phase 3 study of ABP 959 in participants with paroxysmal nocturnal hemoglobinuria.

Test Drug

ABP 959

Active Ingredient

ABP 959

Dosage Form

Solution

Dosage

10

Endpoints

Hemolysis as measured by Lactate dehydrogenas (LDH) (Parallel Comparison) [ Time Frame: 12 months ]
Hemolysis as measured by LDH (Crossover Comparison) [ Time Frame: 18 months ]

Inclution Criteria

Inclusion Criteria:

Men and women ≥ 18 years of age.
Historical diagnosis of PNH.
Administration of eculizumab for ≥ 6 months and currently receiving 900 mg of eculizumab.
Hemoglobin ≥ 9.0 g/dL for at least 6 weeks before randomization.
Lactate dehydrogenase < 1.5 × the upper limit of normal at screening.
Platelet count ≥ 50 × 10^9/L.
Absolute neutrophil count (ANC) > 0.5 x 10^9/L (500/μL).
Participants must be vaccinated against Neisseria meningitidis.
Participants must sign an IRB/IEC-approved ICF before participation in any procedures.

Exclusion Criteria

Exclusion Criteria:

Known or suspected hereditary complement deficiency.
Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure [New York Heart Association ≥ Class III], serious uncontrolled cardiac arrhythmia), peripheral vascular disease, cerebrovascular accident, or transient ischemic attack in the previous 6 months.
Evidence of acute thrombosis (liver Doppler ultrasound of hepatic and portal veins).
Known to be positive for human immunodeficiency virus.
Woman who is pregnant or breastfeeding.
Participant is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or participant is receiving other investigational agent(s).
Participant has known sensitivity to any of the products to be administered during the study, including mammalian cell-derived drug products.
History of meningococcal infection.
Presence or suspicion of active bacterial infection, or recurrent bacterial infection.
History of bone marrow transplantation.
Red blood cell transfusion required within 12 weeks before randomization.
Participant experienced ≥ 2 breakthrough events, (ie, signs and symptoms of intravascular hemolysis, that require dose and/or schedule adjustments of eculizumab) in the previous 12 months before screening.

The Estimated Number of Participants

  • Taiwan

    9 participants

  • Global

    40 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB