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Trial · Observational

CompletedPhase not statedResults postedRegistry data

FIRMAGON® Intensive Drug Monitoring

NCTNCT05181800 (opens ClinicalTrials.gov in a new tab)Other id000351
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
1,454 participants (actual)
Sponsor
Ferring Pharmaceuticals · Industry
Design
Not stated
Countries
1 country

China

Start
20 Aug 2019
Primary completion
31 Dec 2022
Completion
31 Dec 2022
First posted
6 Jan 2022
Last update posted
27 Sept 2024
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20192020202120222023
  1. Ph –

    FIRMAGON® Intensive Drug Monitoring

    NCT05181800

    20 Aug 2019 to 31 Dec 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

To evaluate the safety profile of FIRMAGON® (to fulfill the regulatory authority's requirement of Intensive Drug Monitoring in Chinese participants 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 participants with prostate cancer in need of ADT, receiving treatment with FIRMAGON®. This program provided the minimum 6 doses and maximum 12 doses of FIRMAGON® to enrolled participants during one-year follow-up. Participants who met the inclusion criteria would or were accepting at least 6 self-financed doses of treatment in a hospital. Participants should return to the hospital for medical assessment every three months. The prescription of 6 (3 doses × 2 times) self-financed doses will be given by doctors after assessment, and the direct-to-participant pharmacy will distribute FIRMAGON® to eligible participants (participants should bring the prescriptions and the last FIRMAGON® boxes to get other doses). All enrolled participants were 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 came first.

Interventions

  • Degarelix CohortOther

Arms1

  • Other

    FIRMAGON® Cohort

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Percentage of Participants With Any Adverse Events (AEs)

    Time frame · From the signing of the informed consent up to the end-of-trial (12 months)

    Registry description

    An AE was defined as any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with treatment.

  2. Percentage of Participants With Serious AEs

    Time frame · From the signing of the informed consent up to the end-of-trial (12 months)

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· From the signing of the informed consent up to the end-of-trial (12 months)

Percentage of Participants With Any Adverse Events (AEs)

GroupValue (Participants)
FIRMAGON Cohort95
Primary outcomeCount of participants· From the signing of the informed consent up to the end-of-trial (12 months)

Percentage of Participants With Serious AEs

GroupValue (Participants)
FIRMAGON Cohort63

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
FIRMAGON CohortFIRMAGON Cohort: Non-interventional55 / 145463 / 145495 / 1454

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Diagnosed with prostate cancer and in need of ADT * Decision made to prescribe FIRMAGON® prior to enrollment * Willingness and ability to provide written informed consent * The participants are taking the marketed drug FIRMAGON® Exclusion Criteria: * Not signed informed consent * Any participants who are unsuitable to participate in this study because of any other reasons will not be qualified to participate in this study.

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