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History of Changes for Study: NCT03818607
A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH (DAHLIA)
Latest version (submitted July 13, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 24, 2019 None (earliest Version on record)
2 February 21, 2019 Study Status and Contacts/Locations
3 March 26, 2019 Study Status and Contacts/Locations
4 May 1, 2019 Recruitment Status, Study Status and Contacts/Locations
5 May 22, 2019 Contacts/Locations and Study Status
6 June 5, 2019 Study Status and Contacts/Locations
7 July 24, 2019 Study Status and Contacts/Locations
8 September 4, 2019 Study Status and Contacts/Locations
9 October 24, 2019 Study Status, Oversight and Contacts/Locations
10 November 20, 2019 Study Status and Contacts/Locations
11 November 27, 2019 Contacts/Locations and Study Status
12 December 4, 2019 Study Status and Contacts/Locations
13 February 19, 2020 Study Status and Contacts/Locations
14 March 11, 2020 Study Status and Contacts/Locations
15 April 15, 2020 Contacts/Locations and Study Status
16 May 6, 2020 Study Status, IPDSharing and Contacts/Locations
17 May 13, 2020 Contacts/Locations and Study Status
18 May 27, 2020 Study Status
19 June 3, 2020 Study Status and Contacts/Locations
20 June 17, 2020 Contacts/Locations and Study Status
21 July 1, 2020 Study Status and Contacts/Locations
22 July 8, 2020 Contacts/Locations and Study Status
23 July 22, 2020 Contacts/Locations and Study Status
24 July 29, 2020 Study Status and Contacts/Locations
25 August 12, 2020 Study Status and Contacts/Locations
26 September 30, 2020 Study Status and Contacts/Locations
27 October 21, 2020 Study Status and Contacts/Locations
28 November 4, 2020 Study Status
29 November 26, 2020 Contacts/Locations and Study Status
30 January 13, 2021 Study Status and Contacts/Locations
31 January 19, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
32 September 22, 2021 Contacts/Locations and Study Status
33 November 15, 2021 Study Status and Contacts/Locations
34 January 11, 2022 Study Status and Contacts/Locations
35 March 17, 2022 Study Status
36 June 15, 2022 Study Status
37 July 13, 2022 Recruitment Status and Study Status
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Study NCT03818607
Submitted Date:  January 24, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: 20150168
Brief Title: A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH (DAHLIA)
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)
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2019
Overall Status: Not yet recruiting
Study Start: January 31, 2019
Primary Completion: February 3, 2021 [Anticipated]
Study Completion: February 3, 2021 [Anticipated]
First Submitted: January 17, 2019
First Submitted that
Met QC Criteria:
January 24, 2019
First Posted: January 28, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
January 24, 2019
Last Update Posted: January 28, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Amgen
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This is a randomized, double-blind, active-controlled phase 3 study of ABP 959 in participants with paroxysmal nocturnal hemoglobinuria.
Detailed Description:
Open or close this module Conditions
Conditions: Paroxysmal Nocturnal Hemoglobinuria
Keywords: Marchiafava-Micheli Syndrome
Paroxysmal Cold Hemoglobinuria
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Crossover Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 Names:
  • 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 Names:
  • Treatment T
Drug: Eculizumab
intravenous infusion
Other Names:
  • Soliris
  • Treatment R
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Amgen Call Center
Telephone: 866-572-6436
Email: medinfo@amgen.com
Study Officials: MD
Study Director
Amgen
Locations: Italy
Research Site
Ravenna, Italy, 48121
Open or close this module IPDSharing
Plan to Share IPD: Yes
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Information:
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
Open or close this module References
Citations:
Links: Description: AmgenTrials clinical trials website
Available IPD/Information:

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