FIRMAGON Intensive Drug Monitoring Protocol

February 6, 2023 updated by: Ferring Pharmaceuticals

A Multi-center, Single-arm, Non-interventional Study to Describe the Safety of FIRMAGON® (Degarelix Acetate for Injection) in Chinese Patients With Prostate Cancer and Need Androgen Deprivation Therapy

To evaluate the safety profile of FIRMAGON (to fulfill the regulatory authority's requirement of Intensive Drug Monitoring in Chinese patients with prostate cancer need androgen deprivation therapy [ADT] treated with FIRMAGON).

Study Design

This study is a multi-center, single-arm, non-interventional, prospective study among Chinese patients with prostate cancer and need ADT receiving treatment with FIRMAGON. This program will provide the minimum 6 doses and maximum 12 doses of FIRMAGON to enrolled patients during one-year follow-up. Patients who meet inclusion criteria and will or are accepting at least 6 self-financed doses treatment in hospital. Patients should return to the hospital for medical assessment every three months. The prescription of 6 (3 dose × 2 times) self-financed doses will be given by doctors after assessment, and the direct-to-patient pharmacy will distribute FIRMAGON to eligible patients (patients should bring the prescriptions and the last FIRMAGON boxes to get other doses). All enrolled patients will be followed up to collect safety information for one year from the 1st dose unless withdrawal of Informed Consent Form, discontinuation for 2 months, lost to follow-up, death, or termination due to other reasons, whichever comes first.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2193

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • China Primary Healthcare Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Adult patients with diagnosis of prostate cancer needing ADT.

Description

Inclusion Criteria:

  • Diagnosis as prostate cancer and need ADT
  • Decision made to prescribe FIRMAGON prior to enrollment
  • Willingness and ability to provide written informed consent
  • The patients are taking the marketed drug FIRMAGON

Exclusion Criteria:

  • Not signed informed consent
  • Any patients who is unsuitable to participate in this study because of any other reasons will not be qualified to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
FIRMAGON Cohort
Other: FIRMAGON Cohort
Non-interventional
Other Names:
  • Degarelix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of subjects with any adverse events (AEs)
Time Frame: From the signing of the informed consent up to the end-of-trial (12 months)
An AE was defined as any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have to have a causal relationship with treatment.
From the signing of the informed consent up to the end-of-trial (12 months)
Percentage of subjects with serious AEs
Time Frame: From the signing of the informed consent up to the end-of-trial (12 months)
An SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event or reaction.
From the signing of the informed consent up to the end-of-trial (12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2019

Primary Completion (ACTUAL)

December 31, 2022

Study Completion (ACTUAL)

December 31, 2022

Study Registration Dates

First Submitted

December 20, 2021

First Submitted That Met QC Criteria

December 20, 2021

First Posted (ACTUAL)

January 6, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000351

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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