FIRMAGON Intensive Drug Monitoring Protocol
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| FIRMAGON Cohort
|
Other: FIRMAGON Cohort
Non-interventional
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of subjects with any adverse events (AEs) [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.
- Percentage of subjects with serious AEs [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.
Eligibility Criteria
Criteria
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
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The patients are taking the marketed drug FIRMAGON
Exclusion Criteria:
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | China Primary Healthcare Foundation | Beijing | China |
Sponsors and Collaborators
- Ferring Pharmaceuticals
Investigators
- Study Director: Global Clinical Compliance, Ferring Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 000351