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Specified Drug-use Surveillance of Fabhalta Capsules

NCT ID: NCT06606314

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-18

Study Completion Date

2028-09-30

Brief Summary

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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.

Detailed Description

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The observation period will be 48 weeks after the start of treatment with Fabhalta.

For patients in whom treatment with Fabhalta is discontinued within 48 weeks after the start of the treatment, adverse events occurring by the last day of the treatment + 30 days and concomitant drugs will be monitored and recorded in CRFs.

Conditions

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Paroxysmal Nocturnal Hemoglobinuria

Keywords

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paroxysmal nocturnal hemoglobinuria PNH Fabhalta

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

All patients who received Fabhalta.

·

Exclusion Criteria

Patients receiving Fabhalta for an unapproved indication under the Clinical Trials Act or GCP.
Minimum Eligible Age

0 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Handa, Aichi-ken, Japan

Site Status RECRUITING

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status RECRUITING

Novartis Investigative Site

Okazaki, Aichi-ken, Japan

Site Status RECRUITING

Novartis Investigative Site

Toyohashi, Aichi-ken, Japan

Site Status RECRUITING

Novartis Investigative Site

Toyota, Aichi-ken, Japan

Site Status RECRUITING

Novartis Investigative Site

Hachinohe, Aomori, Japan

Site Status RECRUITING

Novartis Investigative Site

Kashiwa, Chiba, Japan

Site Status RECRUITING

Novartis Investigative Site

Matsuyama, Ehime, Japan

Site Status RECRUITING

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Site Status RECRUITING

Novartis Investigative Site

Kurume, Fukuoka, Japan

Site Status RECRUITING

Novartis Investigative Site

Aizu-Wakamatsu, Fukushima, Japan

Site Status RECRUITING

Novartis Investigative Site

Kohriyama, Fukushima, Japan

Site Status RECRUITING

Novartis Investigative Site

Maebashi, Gunma, Japan

Site Status RECRUITING

Novartis Investigative Site

Fukuyama, Hiroshima, Japan

Site Status RECRUITING

Novartis Investigative Site

Hakodate, Hokkaido, Japan

Site Status RECRUITING

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Site Status RECRUITING

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Site Status RECRUITING

Novartis Investigative Site

Amagasaki, Hyōgo, Japan

Site Status RECRUITING

Novartis Investigative Site

Kobe, Hyōgo, Japan

Site Status RECRUITING

Novartis Investigative Site

Kobe, Hyōgo, Japan

Site Status RECRUITING

Novartis Investigative Site

Nishinomiya, Hyōgo, Japan

Site Status RECRUITING

Novartis Investigative Site

Nishinomiya, Hyōgo, Japan

Site Status RECRUITING

Novartis Investigative Site

Tsukuba, Ibaraki, Japan

Site Status RECRUITING

Novartis Investigative Site

Tsukuba, Ibaraki, Japan

Site Status RECRUITING

Novartis Investigative Site

Kanazawa, Ishikawa-ken, Japan

Site Status RECRUITING

Novartis Investigative Site

Morioka, Iwate, Japan

Site Status RECRUITING

Novartis Investigative Site

Sakaidechō, Kagawa-ken, Japan

Site Status RECRUITING

Novartis Investigative Site

Kanoya, Kagoshima-ken, Japan

Site Status RECRUITING

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Isehara, Kanagawa, Japan

Site Status RECRUITING

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Site Status RECRUITING

Novartis Investigative Site

Kyoto, Kyoto, Japan

Site Status COMPLETED

Novartis Investigative Site

Uji, Kyoto, Japan

Site Status RECRUITING

Novartis Investigative Site

Ōsaki, Miyagi, Japan

Site Status RECRUITING

Novartis Investigative Site

Miyazaki, Miyazaki, Japan

Site Status RECRUITING

Novartis Investigative Site

Nobeoka, Miyazaki, Japan

Site Status RECRUITING

Novartis Investigative Site

Nagano, Nagano, Japan

Site Status RECRUITING

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Suwa, Nagano, Japan

Site Status RECRUITING

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Ōmura, Nagasaki, Japan

Site Status RECRUITING

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Nagaoka, Niigata, Japan

Site Status RECRUITING

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Beppu, Oita Prefecture, Japan

Site Status RECRUITING

Novartis Investigative Site

Uruma, Okinawa, Japan

Site Status RECRUITING

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Habikino, Osaka, Japan

Site Status RECRUITING

Novartis Investigative Site

Izumi, Osaka, Japan

Site Status RECRUITING

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Moriguchi, Osaka, Japan

Site Status RECRUITING

Novartis Investigative Site

Suita, Osaka, Japan

Site Status RECRUITING

Novartis Investigative Site

Saga, Saga-ken, Japan

Site Status RECRUITING

Novartis Investigative Site

Fukaya, Saitama, Japan

Site Status RECRUITING

Novartis Investigative Site

Kawagoe, Saitama, Japan

Site Status RECRUITING

Novartis Investigative Site

Tokorozawa, Saitama, Japan

Site Status RECRUITING

Novartis Investigative Site

Hikone, Shiga, Japan

Site Status RECRUITING

Novartis Investigative Site

Iwata, Shizuoka, Japan

Site Status RECRUITING

Novartis Investigative Site

Shimotsuke, Tochigi, Japan

Site Status RECRUITING

Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Higashimurayama, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Itabashi Ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Itabashi-ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Meguro City, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Minato-ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Nerima City, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Nerima City, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Ōta-ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Shinagawa Ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Shinjuku Ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Toyama, Toyama, Japan

Site Status RECRUITING

Novartis Investigative Site

Tanabe, Wakayama, Japan

Site Status RECRUITING

Novartis Investigative Site

Kofu, Yamanashi, Japan

Site Status RECRUITING

Novartis Investigative Site

Fukushima, , Japan

Site Status RECRUITING

Novartis Investigative Site

Kagoshima, , Japan

Site Status RECRUITING

Novartis Investigative Site

Kumamoto, , Japan

Site Status RECRUITING

Novartis Investigative Site

Kyoto, , Japan

Site Status RECRUITING

Novartis Investigative Site

Kyoto, , Japan

Site Status RECRUITING

Novartis Investigative Site

Niigata, , Japan

Site Status RECRUITING

Novartis Investigative Site

Osaka, , Japan

Site Status RECRUITING

Novartis Investigative Site

Shizuoka, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Phone: +81337978748

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

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CLNP023C11401

Identifier Type: -

Identifier Source: org_study_id