Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of LFG316 in Patients With Paroxysmal Nocturnal Hemoglobinuria

PHASE2CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

September 9, 2015

Primary Completion Date

May 24, 2022

Study Completion Date

May 24, 2022

Conditions
Paroxysmal Nocturnal Hemoglobinuria
Interventions
BIOLOGICAL

LFG316

"LFG316 20 mg/kg was administered to all patients enrolled in the study:~* Treatment Periods 1 to 3: LFG316 20 mg/kg as i.v. infusion every 2 weeks~* Treatment Period 4: LFG316 20 mg/kg as i.v. infusion every 2 weeks for 4 weeks (total 2 infusions)."

DRUG

LNP023

Treatment Period 4: LNP023 200 mg b.i.d. for approximately 20 weeks. Four capsules (each 50 mg) were administered each time study medication was taken.

Trial Locations (7)

625 00

Novartis Investigative Site, Brno Bohunice

960 1295

Novartis Investigative Site, Fukushima

259-1193

Novartis Investigative Site, Isehara

565 0871

Novartis Investigative Site, Suita

160-0023

Novartis Investigative Site, Shinjuku Ku

951 8520

Novartis Investigative Site, Niigata

LT-08661

Novartis Investigative Site, Vilnius

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY