Clinical Trials

Hansa Biopharma is currently evaluating imlifidase in HLA-sensitized kidney transplant patients. Full details of the clinical program are available through a central database.

Visit clinicaltrials.gov for clinical study information on imlifidase.

 

Interested in being involved?
If you are interested in getting involved in a clinical study, please talk to your physician. They will be able to advise you on whether you would be eligible to enroll into a study and if participation could be right for you.

Hansa Biopharma Expanded Access Policy

Under the 21st Century Cures Act, the manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make available its policy on how it evaluates and responds to requests submitted under section 561(b) of the Federal Food, Drug, and Cosmetic Act for provision of such a drug. 

The following is Hansa’s expanded access policy for drugs that are intended to treat serious diseases:

 

  1. General Criteria. Hansa is not making its unapproved drugs available on an expanded access basis at this time.  In the event that we decide to consider expanded access requests for our investigational drugs, we will evaluate and respond to each expanded access request on a case-by-case basis. 
  2. Clinicaltrials.gov Hansa is not currently making its unapproved drugs available for expanded access use.  In the event that we decide to make our products available on an expanded access basis, this policy will be updated with a hyperlink to the relevant expanded access record(s) on clinicaltrials.gov after such record(s) becomes active.   

As authorized by the 21st Century Cures Act, Hansa may revise this expanded access policy at any time.  Additionally, the posting of this policy by Hansa shall not serve as a guarantee of access to any specific investigational drug by any individual patient.