EUCTR2016-004120-39-SE
Active, not recruiting
Phase 1
An experimental pilot study on immune and inflammatory biomarkers in patients with advanced prostatecancer treated with degarelix vs. GnRH agonist and with cardiovascular disease
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with advanced prostate cancer and pre-existing cardiovascular disease
- Sponsor
- Region Skåne
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years of age or above
- •Patients with advanced prostate cancer and scheduled for androgen deprivation treatment for at least 8 weeks
- •Patients with a history of cardiovascular disease according to specified criteria
- •Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 10
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 20
Exclusion Criteria
- •Current or prior use in the past 6 months of androgen deprivation therapy
- •Prior use of dutasteride/finasteride or antiandrogen in the past 6 months
- •Ongoing diagnosed chronic or immune disease
- •Known or suspected allergy to medications used in the study
- •QT\-interval at ECG\>450 ms
- •Subject has total bilirubin \>\= 1\.5 x ULN (except subjects with Gilberts disease), or alanine aminotransferase (ALT) or aspartate aminotransferase \>\= 2\.5 x ULN at screening
- •Creatine \> 2 mg/dL (177 umol) at screening
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Not Applicable
Acupuncture and reproductive health outcomes: building evidence in an integrated care setting.Immune System HealthReproductive HealthReproductive Health and Childbirth - Fertility including in vitro fertilisationInflammatory and Immune System - Normal development and function of the immune systemAlternative and Complementary Medicine - Other alternative and complementary medicineACTRN12609000923268niversity of Western Sydney40
Active, not recruiting
Not Applicable
Exploratory study on inflammatory immune response related to endothelial dysfunction in HIV-infected na?ve patients treated with abacavir compared to tenofovir-based regimens. - ABRACADABRAEUCTR2009-011662-28-ITAZIENDA OSPEDALIERA SAN GERARDO DI MONZA
Recruiting
Not Applicable
A pilot study to investigate the immunological regulation of preeclampsiaO14Pre-eclampsiaDRKS00025864Carl von Ossietzky Universität Oldenburg/Klinikum Oldenburg; Universitätsklinik für Gynäkologie und Geburtshilfe200
Not yet recruiting
Phase 1
A Pilot Study: Safety and Immunological Response following Intradermal COVID-19 vaccination in The Booster (3rd dose)healthy volunteerSafety and Immunological Response Intradermal COVID-19 vaccinationTCTR20210907003Faculty of Medicine Siriraj Hospital, Mahidol University60
Not yet recruiting
Phase 1
A Pilot Study: Safety and Immunological Response following Intradermal COVID-19 vaccination with Accelerate RegimeHealthy volunteerCOVID-19vaccinesafetyimmunological responseintradermalAccelerate RegimenTCTR20210904004Health Systems Research Institute (HSRI)60