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Clinical Trials in Japan / NCT06606314
Active, not recruiting Observational

Specified Drug-use Surveillance of Fabhalta Capsules

NCT06606314 · tracked via the Priya Life Science Japan tracker
Sponsor
Novartis Pharmaceuticals
Phase
Observational
Started
2024-09-18
Last updated
2026-09-10

Condition(s) studied

Paroxysmal Nocturnal Hemoglobinuria

Study summary

This is a multicenter, single-arm, non-interventional study (NIS) with a central registration system and an all-case surveillance system. The observation period is 48 weeks after the start of treatment with Fabhalta.

Eligibility

Sex
ALL
Min age
0 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: All patients who received Fabhalta. · Exclusion Criteria: Patients receiving Fabhalta for an unapproved indication under the Clinical Trials Act or GCP.

Primary outcome measure(s)

  • Occurrence status of infections. — 48weeks
    Type, incidence, seriousness, severity, clinical course, factors affecting onset (status of vaccination, name of vaccine administered, complications, baseline white blood cell count/neutrophil count, etc.), and causative organism (including serotype) of adverse events/adverse drug reactions of infections during the treatment period.

Trial sites (91)

FacilityCityRegionStatus
Novartis Investigative Site Handa Aichi-ken
Novartis Investigative Site Nagoya Aichi-ken
Novartis Investigative Site Nagoya Aichi-ken
Novartis Investigative Site Okazaki Aichi-ken
Novartis Investigative Site Toyohashi Aichi-ken
Novartis Investigative Site Toyota Aichi-ken
Novartis Investigative Site Toyota Aichi-ken
Novartis Investigative Site Hachinohe Aomori
Novartis Investigative Site Chiba Chiba
Novartis Investigative Site Funabashi Chiba
Novartis Investigative Site Kashiwa Chiba
Novartis Investigative Site Narita Chiba
Novartis Investigative Site Matsuyama Ehime
Novartis Investigative Site Fukuoka Fukuoka
Novartis Investigative Site Kurume Fukuoka
Novartis Investigative Site Aizu-Wakamatsu Fukushima
Novartis Investigative Site Kohriyama Fukushima
Novartis Investigative Site Maebashi Gunma
Novartis Investigative Site Fukuyama Hiroshima
Novartis Investigative Site Hakodate Hokkaido
Novartis Investigative Site Sapporo Hokkaido
Novartis Investigative Site Sapporo Hokkaido
Novartis Investigative Site Amagasaki Hyōgo
Novartis Investigative Site Ashiya Hyōgo
Novartis Investigative Site Himeji Hyōgo
Novartis Investigative Site Kobe Hyōgo
Novartis Investigative Site Kobe Hyōgo
Novartis Investigative Site Nishinomiya Hyōgo
Novartis Investigative Site Nishinomiya Hyōgo
Novartis Investigative Site Tsukuba Ibaraki
Novartis Investigative Site Tsukuba Ibaraki
Novartis Investigative Site Tsukuba Ibaraki
Novartis Investigative Site Morioka Iwate
Novartis Investigative Site Sakaidechō Kagawa-ken
Novartis Investigative Site Kanoya Kagoshima-ken
Novartis Investigative Site Isehara Kanagawa
Novartis Investigative Site Yokohama Kanagawa
Novartis Investigative Site Kumamoto Kumamoto
Novartis Investigative Site Kyoto Kyoto
Novartis Investigative Site Uji Kyoto

+ 51 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in Japan

Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease Active, not recruiting
An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Active, not recruiting
Fabhalta Capsules Specified Drug-use Survey Active, not recruiting
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. Recruiting
Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP Recruiting

Other trials for the same condition

Long-term Safety and Tolerability of Iptacopan in Patients With Paroxysmal Nocturnal Hemoglobinuria Active, not recruiting
A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment Active, not recruiting
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors Active, not recruiting
A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to Complement Component 5 Inhibitor (C5i) in Participants With PNH Active, not recruiting
A Study in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate How Safe Long-term Treatment With Pozelimab + Cemdisiran Combination Therapy is and How Well it Works Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06606314 on ClinicalTrials.gov ↗ ← All trials in Japan