Date: 2014-11-10
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the Congress of the American Association of the Study of Liver Disease (AASLD) in Boston, Massachusetts, USA.
Company: Biotest (Germany)
Product: Civacir®
Action
mechanism: Civacir® is an intravenous immune globulin preparation with high titer of hepatitis C (HVC) antibodies. It is currently being investigated for the prevention of HCV recurrence in patients undergoing liver transplantation. Civacir® is administered during the critical time after liver transplantation, when patients are receiving immunosuppressive therapy and treatment with approved antiviral therapies is not indicated.
Disease: hepatitis C
Therapeutic area: Infectious diseases
Country: USA
Trial
details: This randomized, open-label Phase III trial conducted in 24 clinical centers in the United States is to evaluate the efficacy, safety and pharmacokinetics in the hepatitis C positive transplant population. All patients in the study received antiviral treatment prior to transplantation, including new recently approved virostatics. Patients were randomly assigned to the study drug or the control group. Patients who received the study drug received either 200 mg/kg or 300 mg/kg body weight in the peri- and post transplant periods. The control group received no study drug. (NCT01804829)
Latest
news: * On November 10, 2014, Biotest announced in an oral presentation the efficacy and safety interim results from its ongoing US Phase III study (Study 988) with Civacir® at the Congress of the American Association of the Study of Liver Disease (AASLD) in Boston, Massachusetts, USA. Biotest Pharmaceuticals Corporation (BPC) (a subsidiary of Biotest AG) is the only manufacturer of an investigational Hepatitis C immune globulin (Civacir®) worldwide. In the ongoing Phase III trial, Civacir® is being investigated in patients who receive a liver transplant due to chronic hepatitis C infection. This randomized, open-label Phase III trial conducted in 24 clinical centers in the United States is to evaluate the efficacy, safety and pharmacokinetics in the hepatitis C positive transplant population. More than half of the planned patient number has been enrolled in the study. To date, none (0%) of the patients in the higher dosage group have experienced HCV recurrence. Control subjects have a 35% HCV recurrence rate.
