An exploratory study to evaluate in vivo, ex vivo and clinical hypersensitivity reactions after first-time treatment with complement-reactogenic infusions
- Conditions
- CARPAhypersensitivity1000170810027656
- Registration Number
- NL-OMON56981
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 60
1. Patients who have an indication for receiving potentially complement
reactogenic treatments (e.g. paclitaxel or liposomal doxorubicin (Caelyx))
according to their clinical treatment protocol as prescribed by their treating
medical specialist. Patients eligible for participation may include, but will
not be limited to, patients with breast cancer or ovarian cancer.
2. Able and willing to give written informed consent and to comply with the
study restrictions.
3. Has the ability to communicate well with the Investigator in the Dutch or
English language and willing to comply with the study restrictions.
1. Previous treatment with same complement reactogenic treatment (e.g.
paclitaxel or liposomal doxorubicin (Caelyx) (e.g. in case of reintroduction)
2. Subjects with poor venous access limiting phlebotomy.
3. Patients with known complement deficiencies.
4. Patients who received plasma infusions within a week of the first infusion
day.
5. Any condition that would, in the opinion of the investigator, potentially
compromise the safety of the patient or may preclude the patient*s successful
completion of the clinical trial.
6. Patients receiving chemotherapeutic combination therapy during the study
period (first treatment day).
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method