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A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH (DAHLIA)

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ClinicalTrials.gov Identifier: NCT03818607
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

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

Condition or disease Intervention/treatment Phase
Paroxysmal Nocturnal Hemoglobinuria Drug: ABP 959 Drug: Eculizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : April 24, 2019
Estimated Primary Completion Date : July 28, 2020
Estimated Study Completion Date : February 3, 2021


Arm Intervention/treatment
T (ABP 959) / R (eculizumab)
ABP 959 for 52 weeks in Period 1 followed by eculizumab for 26 weeks in Period 2
Drug: ABP 959
intravenous infusion
Other Name: Treatment T

Drug: Eculizumab
intravenous infusion
Other Names:
  • Soliris
  • Treatment R

R (eculizumab) / T (ABP 959)
Eculizumab for 52 weeks in Period 1 followed by ABP 959 for 26 weeks in Period 2
Drug: ABP 959
intravenous infusion
Other Name: Treatment T

Drug: Eculizumab
intravenous infusion
Other Names:
  • Soliris
  • Treatment R




Primary Outcome Measures :
  1. Hemolysis as measured by Lactate dehydrogenas (LDH) (Parallel Comparison) [ Time Frame: 12 months ]
  2. Hemolysis as measured by LDH (Crossover Comparison) [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Total hemolytic complement (Total Complement) [ Time Frame: 18 months ]
  2. Total hemoglobin [ Time Frame: 18 months ]
  3. Serum-free hemoglobin [ Time Frame: 18 months ]
  4. Haptoglobin [ Time Frame: 18 months ]
  5. Bilirubin [ Time Frame: 18 months ]
  6. Degree of hemoglobinuria [ Time Frame: 18 months ]
  7. Type III erythrocytes [ Time Frame: 18 months ]
  8. Crossover comparison of hemolysis as measured by LDH [ Time Frame: 18 months ]
  9. Lactate dehydrogenase-time profile [ Time Frame: 18 months ]
  10. Incidence of red blood cell transfusion [ Time Frame: 18 months ]
  11. Pharmacokinetic area under the curve (AUC) of ABP 959 [ Time Frame: 18 months ]
  12. Pharmacokinetic area under the curve (AUC) of eculizumab [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818607


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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Germany
Research Site Recruiting
Göppingen, Baden-wuerttemberg, Germany, 73035
Italy
Research Site Recruiting
Cremona, Italy, 26100
Research Site Recruiting
Ravenna, Italy, 48121
Research Site Recruiting
Rimini, Italy, 47923
Netherlands
Research Site Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GA
Spain
Research Site Recruiting
Madrid, Spain, 28007
United Kingdom
Research Site Recruiting
London, England, United Kingdom, SE5 9RS
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03818607     History of Changes
Other Study ID Numbers: 20150168
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
URL: https://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amgen:
Marchiafava-Micheli Syndrome
Paroxysmal Cold Hemoglobinuria

Additional relevant MeSH terms:
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Hemoglobinuria
Hemoglobinuria, Paroxysmal
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Anemia, Hemolytic
Anemia
Hematologic Diseases
Myelodysplastic Syndromes
Bone Marrow Diseases