Specified Drug-use Surveillance of Fabhalta Capsules

Last updated: January 12, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aplastic Anemia

Anemia

Proteinuria

Treatment

N/A

Clinical Study ID

NCT06606314
CLNP023C11401
  • Ages < 100
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

All patients who received Fabhalta.

·

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 100
Study Start date:
September 19, 2024
Estimated Completion Date:
September 30, 2028

Study Description

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.

Connect with a study center

  • Novartis Investigative Site

    Okazaki, Aichi 444-8553
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Toyota, Aichi 471-8513
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kobe, Hyogo 650-0047
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kanoya, Kagoshima 893-0024
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Isehara, Kanagawa 259-1193
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Habikino City, Osaka 583-0872
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Shinagawa ku, Tokyo 141 8625
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Osaka, 542-0081
    Japan

    Active - Recruiting

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