Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Apellis Pharmaceuticals, Inc.
Study ID
NCT03500549
Phase
PHASE3
Status
Completed

Conditions

  • Paroxysmal Nocturnal Hemoglobinuria

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pegcetacoplan — DRUG
    Complement (C3) Inhibitor
  • Soliris — DRUG
    Complement (C5) Inhibitor

Study Details

Evaluation of the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria

Key Dates

Start date
Jun 14, 2018
Status verified
Mar 2022
Primary completion
Nov 14, 2019
Completion
Aug 13, 2020

Study Design

Enrollment
80 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Pegcetacoplan
    1080 mg pegcetacoplan administered subcutaneously twice-weekly or every three days.
  • Active Comparator: Eculizumab
    Complement (C5) Inhibitor.

Primary Outcome Measure

Least Squares (LS) Mean Change From Baseline to Week 16 in Hemoglobin (Hb) Level During the RCP [ Time Frame: Baseline and Week 16 ]

Locations (19)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90033-
Sarcoma Oncology Research CenterSanta MonicaCalifornia90403-
Denver HealthDenverColorado80204-
Georgetown University HospitalWashington D.C.District of Columbia20057-
Cancer Specialists of North FloridaJacksonvilleFlorida32256-
Lakes ResearchMiami LakesFlorida33014-
Mid Florida Hematology and OncologyOrange CityFlorida32763-
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611-
Investigative Clinical Research of IndianaIndianapolisIndiana46260-
Cancer & Hematology Centers of Western MichiganGrand RapidsMichigan49503-
Roswell Park Cancer InstituteBuffaloNew York14263-
New York Cancer & Blood SpecialistsEast SetauketNew York11733-
New York Cancer & Blood SpecialistsThe BronxNew York10469-
Duke University Medical CenterDurhamNorth Carolina27710-
Good Samaritan HospitalCorvallisOregon97330-
University of Tennessee Medical CenterKnoxvilleTennessee37920-
Baptist Cancer CenterMemphisTennessee38120-
HOPE Cancer Center of East TexasTylerTexas75701-

Find similar trials in Los Angeles, CA

By research site
University of Southern California· Los Angeles, CASarcoma Oncology Research Center· Santa Monica, CADenver Health· Denver, COGeorgetown University Hospital· Washington D.C., DCCancer Specialists of North Florida· Jacksonville, FLLakes Research· Miami Lakes, FL

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