Specified Drug-use Surveillance of Fabhalta Capsules
Launched by NOVARTIS PHARMACEUTICALS · Sep 18, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying Fabhalta capsules, a treatment for a rare blood condition called Paroxysmal Nocturnal Hemoglobinuria (PNH). The trial is designed to gather information about how well this medication works and to keep track of any side effects over a period of 48 weeks. It is open to all patients who have received Fabhalta, regardless of their age or gender, as long as they are using the drug for approved reasons.
If you or a family member have been prescribed Fabhalta, you may be eligible to participate in this study. Participants will be monitored closely throughout the 48-week period to ensure their safety and to collect important health information. This trial is currently recruiting new participants, and being part of it can help contribute to a better understanding of how Fabhalta works for patients with PNH.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • All patients who received Fabhalta.
- • ·
- Exclusion Criteria:
- • Patients receiving Fabhalta for an unapproved indication under the Clinical Trials Act or GCP.
About Novartis Pharmaceuticals
Novartis Pharmaceuticals is a global healthcare company dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovation, Novartis engages in the research, development, and commercialization of a broad range of therapies across various therapeutic areas, including oncology, cardiology, dermatology, and neuroscience. The company is committed to advancing scientific knowledge and patient care through clinical trials that prioritize safety and efficacy. Novartis leverages cutting-edge technology and collaborative partnerships to address unmet medical needs and deliver transformative treatments that enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nagoya, Aichi, Japan
Sapporo, Hokkaido, Japan
Shinagawa Ku, Tokyo, Japan
Niigata, , Japan
Suwa, Nagano, Japan
Itabashi Ku, Tokyo, Japan
Minato Ku, Tokyo, Japan
Matsuyama, Ehime, Japan
Shizuoka, , Japan
Isehara, Kanagawa, Japan
Kawagoe, Saitama, Japan
Fukushima City, Fukushima, Japan
Sakaide City, Kagawa, Japan
Iwata, Shizuoka, Japan
Saga City, Saga, Japan
Kurume City, Fukuoka, Japan
Yokohama City, Kanagawa, Japan
Fukuyama, Hiroshima, Japan
Toyota, Aichi, Japan
Toyohashi, Aichi, Japan
Hakodate, Hokkaido, Japan
Kobe, Hyogo, Japan
Tsukuba, Ibaraki, Japan
Osaka, , Japan
Fukaya, Saitama, Japan
Miyazaki, , Japan
Moriguchi, Osaka, Japan
Kanoya, Kagoshima, Japan
Beppu, Oita, Japan
Toyama, , Japan
Handa, Aichi, Japan
Uruma, Okinawa, Japan
Kanazawa, Ishikawa, Japan
Shinjuku Ku, Tokyo, Japan
Okazaki, Aichi, Japan
Habikino City, Osaka, Japan
Osaki, Miyagi, Japan
Hikone, Shiga, Japan
Nerima, Tokyo, Japan
Kyoto, , Japan
Patients applied
Trial Officials
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported