The extensive clinical trials of a new hepatitis B drug involving human beings is launched

05.12.2014

The company Panacea Infarm continues to work on a clinical trial for patients suffering from chronic viral hepatitis B with the delta agent. This modified, more serious infection of the hepatitis D virus occurs in 5% of cases and may significantly interfere with a treatment course. Patients with such infection type have twice more often serious consequences and mortality cases by comparing them with patients diagnosed with a monoinfection.

The project includes the extensive laboratory tests focused on the thorough study of pharmacological features of the new FABI256 medication. The clinical trial (CT) of the drug reached the 4th phase. During the preclinical studies held in 2013, the scientists from the Walter and Eliza Hall Institute of Medical Research managed to save hundreds of laboratory rodents from hepatitis B.

At the present time, the recruitment of volunteers for CT of the experimental drug is in progress. Panacea Infarm includes the first patient with chronic viral hepatitis B with a delta agent in the clinical trials of the innovative drug.

According to the “FAB 256” protocol, the purpose of CT is to evaluate the efficacy and safety of a medical product, to gather the information about side effects, their potential danger to human health and life. Based on the gathered data, the authorized health organizations (FDA, WHO) make a decision on the registration of a new medical product or explain their denial to register a drug for sale on the pharmaceutical market.

The company Panacea Infarm is recruiting 60 patients by the end of 2015 in collaboration with the largest medical centers. Volunteers are divided into 2 groups. One group gets the medical product and placebo, i.e. the treatment without any active components. The second group gets only the placebo. Such clinical trials help to evaluate the drug’s effect on the patient’s condition.

Participation in clinical trials

The whole process of a clinical trial is described in the research protocol:

• criteria for acceptance and exclusion of participants;
• duration;
• schedule of the drug admission;
• possible risks and benefits;
• the list of analyses and tests that every patient must do.

A doctor interviews every patient and tells about all aspects of a clinical trial. If there are no objections, a volunteer is included in the trial program. The protocol is offered for detailed research for the patient after he or she agrees in writing that his/her participation is comprehended and voluntary. At any time, a participant can quit the program without explaining the reasons for his or her decision.

According to Marc Pellegrini’s comments, the CT results of the 4th phase are expected with anticipation and great hopes. The new product has a great potential to get approval from all organizations and become the new standard for chronic hepatitis B treatment.