From: Expanded Access Programme: looking for a common definition
Case model 3 Therapeutic area: Viral diseases | ||||
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Clinical study design | Target | Endpoints | Italian or international | Phase |
Multicentre, open-label, single-arm, early-access | Patients with chronic hepatitis C, acute fibrosis and cirrhosis | Primary: make possible early use of the drug for patients who cannot participate in the clinical trial | International | Phase 3 |
Patients with similar features to those in the clinical trial but unable to participate because the trial is closed or the trial site is not geographically accessible, or because not eligible under ongoing trial protocols | Secondary: assess the safety and tolerability of the treatment |