An exploratory study to evaluate in vivo, ex vivo and clinical hypersensitivity reactions after first-time treatment with complement-reactogenic infusions

An exploratory study to evaluate in vivo, ex vivo and clinical hypersensitivity reactions after first-time treatment with complement-reactogenic infusions - In vivo and ex vivo complement activation

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56981

Enrollment

Registered

2024-08-30

Start date

2024-11-15

Completion date

Unknown

Last updated

2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CARPA hypersensitivity

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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).

Design outcomes

Primary

Measure	Time frame
May include, but not limited to: • Complement activation products in plasma: C3a, C3d, sC5b9. Will be evaluated against baseline. • Complement levels in serum after ex vivo incubation: sC5b9	—

Secondary

Measure	Time frame
• Adverse events (AEs) • Adverse Events of Special Interest (AESIs): symptoms of infusion-mediated reactions including: o Flushing o Itching o Alterations in heart rate and/or blood pressure o Respiratory symptoms (including dyspnoea, chest discomfort, wheezing) o Back- or abdominal pain o Gastrointestinal symptoms o Skin reactions (including urticaria) o Angioedema o Temperature changes o Dysgeusia (metallic taste)	—

Measure

Time frame

• Adverse events (AEs) • Adverse Events of Special Interest (AESIs): symptoms of infusion-mediated reactions including: o Flushing o Itching o Alterations in heart rate and/or blood pressure o Respiratory symptoms (including dyspnoea, chest discomfort, wheezing) o Back- or abdominal pain o Gastrointestinal symptoms o Skin reactions (including urticaria) o Angioedema o Temperature changes o Dysgeusia (metallic taste)

—

Countries

Netherlands

Outcome results