EICHORCondition: Paroxysmal Nocturnal Hemoglobinuria · Sponsor: Novartis Pharmaceuticals
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
This study is an open-label, single arm, multicenter, roll-over extension study to characterize long-term safety, tolerability and efficacy of iptacopan and to provide access to iptacopan to patients with PNH who have completed Novartis-sponsored Phase 2 or 3 studies with iptacopan
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Inclusion criteria: * Male and female participants ≥ 18 years of age with a diagnosis of PNH who have completed the treatment extension period (without tapering down) of Phase II iptacopan studies (CLNP023X2204, CLNP023X2201), Period 4 of LFG316X2201 or Phase III (CLNP023C12302 and CLNP023C12301) clinical studies at the time point of enrollment visit in this roll over extension. * Prior vaccinations against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections * Per investigator's clinical judgement benefit from continued treatment with iptacopan and has been clinically stable on iptacopan monotherapy for at least 3 months Exclusion Criteria: * Any comorbidity or medical condition (including but not limited to any active systemic bacterial, viral or fungal infection or malignancy) that, in the opinion of the investigator, could put the subject at increased risk or potentially confound study data. * History of recurrent invasive infections caused by encapsulated organisms, such as Neisseria meningitidis, Streptococcus pneumoniae or Haemophilus influenzae * History of hematopoietic stem cell transplantation Other protocol-defined inclusion/exclusion criteria may apply.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| City Of Hope National Med Center | Duarte, California, United States | — |
| City Of Hope | Duarte, California, United States | — |
| USC Norris Cancer Center | Los Angeles, California, United States | — |
| Univ Cali Irvine ALS Neuromuscular | Orange, California, United States | — |
| Univ of California Irvine (Chao Family Comprehensive Cancer Center) | Orange, California, United States | — |
| Lakes Research | Miami Lakes, Florida, United States | — |
| Augusta University Georgia | Augusta, Georgia, United States | — |
| Augusta University | Augusta, Georgia, United States | — |
| Montefiore Medical Center | The Bronx, New York, United States | — |
| Cleveland Clinic Foundation | Cleveland, Ohio, United States | — |
| Prisma Health Upstate | Greenville, South Carolina, United States | — |
| Novartis Investigative Site | Santo André, São Paulo, Brazil | — |
+ 48 more locations — full list on the registry record.
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This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT04747613