These may include:
- Helping to test an investigational new medication with the potential for self-administration during the time of the clinical trial
- Helping to develop new medicines or treatments that can potentially benefit patients with acromegaly in the future
- Helping to support medical science and improve knowledge about the treatment of acromegaly
- Receiving no-cost health examinations
What is the purpose of the HS-18-633 and HS-19-647 clinical trials?
The purpose of these clinical trials is to evaluate CAM2029, a new investigational product for self-administration and home use (HS-19-647) in the treatment of patients with acromegaly.
What is the difference between the HS-18-633 and HS-19-647 clinical trials?
HS-18-633 and HS-19-647 are both phase 3 clinical trials in acromegaly patients but HS-18-633 is a double-blind placebo-controlled trial and HS-19-647 is an open-label trial. The trials differ slightly in the patient population. Patients in HS-18-633 have well-controlled disease. Trial HS-19-647 allows also patients with not that well controlled IGF-1 levels and patients that have undergone radiotherapy.
How long will the HS-18-633 and HS-19-647 clinical trials last?
The HS-18-633 trial treatment period consist of 6 monthly doses and the total duration of the trial will be about 7-8 months including a screening period. The screening period will include laboratory tests and interview to judge if you are eligible to participate in the trials.
For HS-19-647, the treatment period will last for 12 months (13 monthly doses) and 1-2 months of screening for those only participating in the HS-19-647 trial. However, the participation in HS-19-647 will only be 6 months for those patients that first participated in HS-18-633 trial.
The screening period will include laboratory tests together with an interview to judge if you are eligible to participate in the trials.
What is a double-blind trial?
What is a placebo-controlled trial?
What happens if my condition worsens in the placebo controlled trial?
As a patient in the HS-18-633 trial you will be closely followed. It is possible to switch back to standard of care treatment (rescue therapy) if you experience worsening of clinical signs and symptoms together with an increase of IGF-1 levels above a defined threshold. You should then stay in the trial for all safety follow up and if you fulfill all visits you are welcome to continue into the follow up trial HS-19-647.
What is an open-label trial?
An open-label trial is one in which the patients and the medical staff treating them know which treatment the patient is receiving.
Will I be compensated for participating in the trials?
Local and site specific compensations for covering for example meals, over-night stays and travel may be granted. Rescue therapy will be provided in case of need.