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ACTIVE NOT RECRUITING

NCT03531255

PHASE3

Pegcetacoplan Long Term Safety and Efficacy Extension Study

Sponsor: Apellis Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

This is an Open-label, Non-Randomized, Multi-Center Extension Study. Eligible subjects will have previously completed a pegcetacoplan study.

Official title: An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegcetacoplan in the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2018-08-27

Completion Date

2026-07

Last Updated

2026-04-06

Healthy Volunteers

Conditions

PNH

Interventions

DRUG

Pegcetacoplan

Complement (C3) Inhibitor

Inclusion criteria: 1. Subjects at least 18 years of age with PNH who have participated in a pegcetacoplan clinical trial. Subjects who received treatment with pegcetacoplan must have experienced clinical benefit and adequate tolerability in the opinion of the investigator. Note: Subjects with PNH who completed a pegcetacoplan clinical trial without receiving pegcetacoplan (or without receiving pegcetacoplan for long enough to demonstrate clinical benefit) may be enrolled in this study if, in the opinion of the Investigator, the subject is expected to demonstrate clinical benefit upon the initiation or continuation of pegcetacoplan therapy. 2. Vaccination against Neisseria meningitidis types A, C, W, Y and B, Streptococcus pneumoniae and Haemophilus influenzae Type B (Hib) either within 2 years prior to Day 1 dosing of this study, or within 14 days after starting treatment with pegcetacoplan. Vaccination is mandatory unless documented evidence exists that subjects are nonresponders to vaccination as evidenced by titers or display titer levels within acceptable local limits. Immunization status checks will be performed to determine whether subjects require primary or booster vaccinations. 3. Willing and able to give written informed consent. 4. Willing and able to self-administer pegcetacoplan (administration by caregiver will be allowed) 5. Women of childbearing potential (WOCBP) defined as any females who have experienced menarche and who are NOT permanently sterile or postmenopausal must have a negative pregnancy test and must agree to continue to use an approved method of contraception for the duration of the study and 90 days after their last dose of study drug. Note: Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. 6. Males must agree to continue to use an approved method of contraception and must agree to refrain from donating sperm for the duration of the study and 90 days after their last dose of study drug. Exclusion Criteria: 1. Subjects who have withdrawn from a pegcetacoplan clinical study. 2. Any condition that could increase the subject's risk by participating in the study. 3. Any comorbidity or condition (such as malignancy) that, in the opinion of the investigator, could put the subject at increased risk or potentially confound study data. 4. History or presence of hypersensitivity or idiosyncratic reaction to compounds related to the investigational product or SC administration. 5. Known infection with hepatitis B, C, or HIV. 6. Hereditary complement deficiency. 7. History of bone marrow transplant. 8. Concurrent severe aplastic anemia (SAA), defined as currently receiving immunosuppressive therapy for SAA including but not limited to cyclosporin A, tacrolimus, mycophenolate mofetil or anti-thymocyte globulin. 9. History of meningococcal disease. 10. Concomitant treatment with any complement inhibitor (eg, eculizumab, ravulizumab). 11. Pregnancy, breastfeeding, or positive pregnancy test.

Locations (62)

University of Southern California

Los Angeles, California, United States

Denver Health Medical Center

Denver, Colorado, United States

Cancer Specialists of North Florida

Jacksonville, Florida, United States

Lakes Research

Miami, Florida, United States

Northwestern University

Chicago, Illinois, United States

Investigative Clinical Research of Indiana

Indianapolis, Indiana, United States

Duke University Medical Center

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Baptist Cancer Center

Memphis, Tennessee, United States

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Cliniques Universitaires Saint-luc

Brussels, Belgium

AZ Delta

Roeselare, Belgium

Acibadem City Clinic Tokuda Hospital

Sofia, Bulgaria

National Specialized Hospital for Active Treatment of Haematologic Diseases

Sofia, Bulgaria

University of Calgary

Calgary, Alberta, Canada

Alberta Health Services

Edmonton, Alberta, Canada

Toronto General Hospital

Toronto, Ontario, Canada

IPS Centro Medico Julian Coronel SAS

Cali, Valle del Cauca Department, Colombia

Hospital Center Chalon Sur Saone William Morey

Chalon-sur-Saône, France

CHRU de Lille

Lille, France

Hopital Saint-Louis

Paris, France

Lyon Sud Hospital Center

Pierre-Bénite, France

Centre Hospitalier Annecy Genevois - Site Annecy

Pringy, France

Centre Hospitalier de Saint-Quentin

Saint-Quentin, France

Universitatsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Uniklinik RWTH Aachen

Aachen, North Rhine-Westphalia, Germany

Essen University Hospital Department of Hematology

Essen, North Rhine-Westphalia, Germany

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Prince of Wales Hospital

Hong Kong, Hong Kong

Queen Mary Hospital

Hong Kong, Hong Kong

Japanese Red Cross Nagoya Daini Hospital

Showa-ku, Aichi-ken, Japan

Shinshu University Hospital

Matsumoto, Nagano, Japan

Juntendo University Hospital

Bunkyō-Ku, Tokyo, Japan

Kinan Hospital

Tanabe, Wakayama, Japan

Okayama University Hospital

Okayama, Japan

NTT Medical Center Tokyo

Tokyo, Japan

University Malaya Medical Centre

Lembah Pantai, Kuala Lumpur, Malaysia

Hospital Ampang

Ampang, Selangor, Malaysia

Hospital Universitario "José Eleuterio González", UANL

Monterrey, Mexico

Hospital Nacional Dos De Mayo - Centro de Investigación

Lima Cercado, Lima region, Peru

Centro de Investigacion en Hematologia Clinica del Centro Medico Corpac

San Isidro, Lima region, Peru

Hospital Edgardo Rebagliatti

Jesús María, Lima, Peru

Perpetual Succour Hospital

Cebu, National Capital Region, Philippines

Mary Mediatrix Medical Centre

Lipa City, National Capital Region, Philippines

Makati Medical Centre

Makati City, National Capital Region, Philippines

The Medical City

Pasig, National Capital Region, Philippines

St. Lukes Medical Centre

Quezon City, National Capital Region, Philippines

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, Russia

Therapeutic hospital of regional clinical hospital #1

Tyumen, Russia

Clinical Center of Serbia

Belgrade, Serbia

Singapore General Hospital

Singapore, Singapore

Chungnam National University Hospital

Junggu, Daejeon, South Korea

Hospital Univ. de Gran Canaria Dr.Negrin

Las Palmas de Gran Canaria, Canary Islands, Spain

Hospital Universitario Politecnico La Fe

Valencia, Spain

Phramongkutklao Hospital

Bangkok, Thailand

Ramathibodi Hospital

Bangkok, Thailand

Siriraj Hospital

Bangkok, Thailand

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, Thailand

Srinagarind Hospital

Khon Kaen, Thailand

Thammasat University Hospital

Pathum Thani, Thailand

Songklanagarind Hospital

Songkhla, Thailand

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Clinical Research Directory

Pegcetacoplan Long Term Safety and Efficacy Extension Study

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (62)