Cold Agglutinin Disease

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Cold Agglutinin Disease

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Do you have Cold Agglutinin Disease (CAgD)?

We are looking for individuals who have been medically diagnosed with Primary CAgD to participate in a study to see whether a new investigational product can increase haemoglobin (Hgb) levels in order to eliminate the need for blood transfusions in the treatment of CAgD.

There is currently no cure for CAgD. Patients with severe CAgD can require numerous blood transfusions to manage their anaemia.

We are currently recruiting study participants who:

  • Are 18 years of age or older.
  • Have been medically diagnosed with Primary Cold Agglutinin Disease (CAgD).

The study will be split into two parts. For part A of the study, participants will need to attend 16 clinic visits over a 6-month period. For part B, participants will need to attend fortnightly clinic visits for up to 2 years.

You will be reimbursed for your time.

To see if you are eligible complete the questionnaire or call the Clinical Trials Centre on 07 5456 3797.

Full titles:

Cardinal Study: A Pivotal, Open-Label, Multicenter Study to Assess the Efficacy and Safety of BIVV009 in Patients with Primary Cold Agglutinin Disease who have a Recent History of Blood Transfusion.

Cadenza Study: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of BIVV009 in Patients with Primary Cold Agglutinin Disease Without a Recent History of Blood Transfusion.

Ethics approval – Bellberry Human Research Ethics Committee

If you experience difficulty completing the survey please email trials@usc.edu.au

Start Questionnaire?
Are you 18 years of age or older?
Have you been medically diagnosed with Primary Cold Agglutinin Disease (CAgD)?
Do you have active symptoms of CAgD? These include – Symptomatic anaemia (fatigue, weakness, shortness of breath, palpitations, fast heartbeat, light headedness and/or chest pain), acrocyanosis, Raynaud’s syndrome, hemoglobinuria, disabling circulatory symptoms and/or major adverse vascular events (including thrombosis).
Is your CAgD secondary to infection, rheumatologic disease, or active hematologic malignancy?
If female, are you pregnant or lactating?
If male, are you willing to refrain from sperm donation for the duration of the trial and for at least 90 days after?
Are you willing to use contraception for the duration of the clinical trial?
Do you have a history of Hepatitis B, Hepatitis C or HIV?
Would you be willing to attend up to 16 clinic visits over a 6-month period during part A, and fortnightly visits for up to 2 years during part B, of this study?
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