FDA halts alisporivir (Novartis) Phase III trial - 24-Apr-2012

The FDA has placed a clinical hold on a Phase III trial testing alisporivir (DEB025), from Novartis/Debiopharm, plus pegylated interferon and ribavirin in treatment naive genotype 1 patients with Hepatitis C, after a study participant died potentially of pancreatitis.The death was the first and only fatality in the overall alisporivir clinical study programme involving about 1,800 patients. Results of an earlier Phase II study of alisporivir showed that the drug significantly reduced HCV replication when used alone, and had an important additive anti-HCV effect in combination with pegylated interferon alfa-2a in treatment-naïve patients, with no serious adverse events reported