Last Update: Nov 25, 2024
Specified Drug-use Surveillance of Fabhalta Capsules (Paroxysmal Nocturnal Hemoglobinuria, CLNP023C11401)
ClinicalTrials.gov Identifier:
NCT06606314
Novartis Reference Number:CLNP023C11401
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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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. 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.

Paroxysmal Nocturnal Hemoglobinuria
Recruiting
100
Sep 19, 2024
Sep 30, 2028
All
0 Years - 100 Years (Child, Adult, Older Adult)

Eligibility Criteria

Inclusion Criteria:

All patients who received Fabhalta.

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Exclusion Criteria:

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

Novartis Investigative Site

Recruiting

Shinagawa ku,Tokyo,141 8625,Japan

Worldwide Contacts

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Novartis Pharmaceuticals

+81337978748