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OpenTrials
Completed

NCT Number: NCT03844464

Safety and Efficacy of Lorbrena

To investigate the following matters under post-marketing use of Lorbrena in patients who received this drug

1. Factors affecting the onset of central nervous system disorder 2. Effect of Lorbrena in combination with CYP3A inducers on the onset of hepatic dysfunction

Completed

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Key information

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

3-22-7, Yoyogi, Shibuya-ku

Tokyo, 151-8589, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All administered patients

Exclusion criteria

  • Nothing

Treatment and study plan

Primary outcomes

  1. Incidence of adverse drug reactions of central nervous system disorder and hepatic dysfunction

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Special Investigation for LORBRENA Tablets

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Feb 18, 2019
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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