Clinical trial • Phase IV • Oncology
TINZAPARIN SODIUM for Pancreatic cancer
Phase IV trial of TINZAPARIN SODIUM for Pancreatic cancer. Randomised. 214 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Pancreatic cancer
- Trial Stage
- Phase IV
- Drug Modality
- Other
Key dates
- Initial CTIS Submission Date
- 30-10-2024
- First CTIS Authorization Date
- 27-11-2024
Trial design
Randomised Phase IV trial in Finland.
- Randomised
- Yes
- Target Sample Size
- 214
- Trial Duration For Participant
- 1825
Eligibility
Recruits 214 No vulnerable population selected (isVulnerablePopulationSelected=false). A Subject information and informed consent form document is listed ('Tiedote+suostumus kliinisesta laaketutkimuksesta NAT+tintsapariini'); consent is provided by adult participants. No assent or paediatric consent described..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected=false). A Subject information and informed consent form document is listed ('Tiedote+suostumus kliinisesta laaketutkimuksesta NAT+tintsapariini'); consent is provided by adult participants. No assent or paediatric consent described.
Inclusion criteria
- {"criterion_text":"- An adult pancreatic cancer patient for whom neoadjuvant treatments are being planned due to pancreatic cancer."}
Exclusion criteria
- {"criterion_text":"- The study excludes patients, if they have contraindications for using tinzaparin, are already on anticoagulant medication, have had any other active cancer in the past five years or have severe kidney failure or bleeding tendencies."}
Endpoints
Primary endpoints
- {"endpoint_text":"- As primary endpoints, we collect venous and arterial thrombotic events, bleeding complications, as well as information on disease progression and feasible time and cause of death. Patients are followed for at least five years or until death.","definition_or_measurement_approach":"Collection of venous and arterial thrombotic events, bleeding complications, disease progression, and time and cause of death; patients followed for at least five years or until death."}
Secondary endpoints
- {"endpoint_text":"- We will observe changes in the patient's coagulation activation from venous blood samples during neoadjuvant treatment and disease follow-up. Blood samples will be taken before the start of neoadjuvant treatments, between chemotherapy cycles, after neoadjuvant treatments, and (or after the start of palliative treatments if surgery is not feasible) at months 1, 3, 6, 12, 15, 24, and 36 along with other scheduled blood tests.","definition_or_measurement_approach":"Serial venous blood sampling to measure coagulation-related laboratory variables: before neoadjuvant treatment, between chemotherapy cycles, after neoadjuvant treatments, and at months 1, 3, 6, 12, 15, 24, and 36 (and/or after start of palliative treatments if applicable)."}
Recruitment
- Planned Sample Size
- 214
- Recruitment Window Months
- 120
- Consent Approach
- Subject information and informed consent form is listed (document titled 'Tiedote+suostumus kliinisesta laaketutkimuksesta NAT+tintsapariini'); consent to be provided by adult participants. No details provided on assent, age-specific documents, or languages in the available record.
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 214
Finland
- Earliest CTIS Part Ii Submission Date
- 30-10-2024
- Latest Decision Or Authorization Date
- 27-11-2024
- Processing Time Days
- 28
- Number Of Sites
- 4
- Number Of Participants
- 214
Sites
- Site Name
- HUS-Yhtymae
- Department Name
- Abdominal Center
- Principal Investigator Name
- Hanna Seppänen
- Principal Investigator Email
- hanna.seppanen@hus.fi
- Contact Person Name
- Hanna Seppänen
- Contact Person Email
- hanna.seppanen@hus.fi
- Site Name
- Tampere University Hospital
- Department Name
- Gastroenterology
- Principal Investigator Name
- Johanna Laukkarinen
- Principal Investigator Email
- Johanna.Laukkarinen@pirha.fi
- Contact Person Name
- Johanna Laukkarinen
- Contact Person Email
- Johanna.Laukkarinen@pirha.fi
- Site Name
- Oulu University Hospital
- Department Name
- Abdominal Center
- Principal Investigator Name
- Minna Nortunen
- Principal Investigator Email
- minna.nortunen@pohde.fi
- Contact Person Name
- Minna Nortunen
- Contact Person Email
- minna.nortunen@pohde.fi
- Site Name
- Turku University Hospital
- Department Name
- Department of Digestive Surgery and Urology
- Principal Investigator Name
- Saila Kauhanen
- Principal Investigator Email
- saila.kauhanen@varha.fi
- Contact Person Name
- Saila Kauhanen
- Contact Person Email
- saila.kauhanen@varha.fi
Sponsor
Primary sponsor
- Full Name
- HUS-Yhtymae
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Finland
Co-sponsors
- University Of Helsinki
Investigational products
- Investigational Product Name
- innohep® 3500 anti-Xa IU injektioneste, liuos, kerta-annosruiskussa
- Active Substance
- TINZAPARIN SODIUM
- Modality
- Other
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- Marketing authorised (marketingAuthNumber 33265, country FI)
- Starting Dose
- 3500 anti-Xa IU
- Maximum Dose
- 3500 anti-Xa IU
- Investigational Product Name
- Inhixa 6,000 IU (60 mg)/0.6 mL solution for injection in pre-filled syringe
- Active Substance
- ENOXAPARIN SODIUM
- Modality
- Other
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- Marketing authorised (marketingAuthNumber EU/1/16/1132/016, EU)
- Starting Dose
- 60 mg (6,000 IU)
- Maximum Dose
- 60 mg
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