This is an open randomized multi-center phase II clinical trial of daily administration of the investigational drug in comparison to the well-known medicinal product in patients with HBeAg-negative chronic virus hepatitis.
17 medicinal centers (15 centers in Russia and 2 centers in some of the CIS countries) were planned to be included in the current clinical study in order to enroll 48 patients and randomize them into 6 therapeutic groups. However, enrollment was completed by the strength of just 9 investigative sites. Close and trust relationships with principal investigators and key opinion leaders in a great number of therapeutic areas, including infectious diseases like hepatitis B, helps us guarantee the highest enrollment rates in all the studies we conduct for our sponsors in Central and Eastern Europe and the United States.
The population of patients involved in this study includes patients with HBeAg-negative chronic virus hepatitis B, with mild or medium disease activity.
The primary objective of the current study is to evaluate therapeutic effect of the investigational medicinal product in comparison to the well-known drug used to cure similar indications. Among secondary objectives we can mark out evaluation of the pharmacokinetic profile and the immunogenicity of the investigational drug as well its safety and tolerability.
Hepatitis B is a potentially life-threatening liver infection which is generated by hepatitis B virus (HBV), which causes chronic liver disease and can end up with liver cancer or liver cirrhosis and death.
The number of people who die every year due to the consequences of hepatitis B is estimated by the World Health Organization at about 600 000. There is no doubt that hepatitis B is a serious world healthcare problem and is rated at the 10th place among the reasons of death worldwide. Without appropriate medical treatment, about 25% of patients with chronic hepatitis B die untimely due to the liver disease complications.
Despite the availability of the medicinal products to treat the current disease, including viricides, immunomodulators (interferons), or combined therapies, there is still a huge unrealized medical need for the cure of infection caused by HBV, to be exact, for the long-term eradication of the virus during a limited course of treatment. At the moment, patients suffering from infections caused by HBV generally have to receive long-term or lifelong antiviral therapy, which only corroborates the acuteness of the current clinical trial.
OCT is happy to be of help to its clients providing full support in conducting any type of a clinical trial that might aid patients and safe their lives.