Clinical Trials

Phase 2a trials reopened as U.S. FDA, pharmaceutical company reach agreement

Published in Hepatitis Weekly, September 20th, 2004

XTL Biopharmaceuticals Ltd (XTLbio) announced that it has reached agreement with the U.S. Federal Drug Administration (FDA), to reopen the phase 2a HepeX-C trial for prevention of re-infection in liver transplant patients with pre-existing hepatitis C (HCV) infection to enroll 8 new patients.

The additional safety and efficacy data from this 8 patient cohort will enable a re-evaluation of the decision to resume the highest dosing arm of the trial.

Enrollment of new patients was halted by the company in May after 1 patient in the highest dosing arm of the trial did not survive the transplant operation.

The medical examiner...

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Source: Hepatitis Weekly (2004-09-20)

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