Hepatitis C Virus Infection Clinical Trial
Official title:
Safety and Efficacy Study in Non-Responder Hepatitis C Genotype 1 Patients With PHN121
To evaluate the safety, tolerability and efficacy of escalating dose of PHN121 when administered orally in non-responder hepatitis C genotype 1 patients
This is a Phase I/II, open-label, multicenter (2 centers), dose-escalation, multidose study
in non-responder hepatitis C genotype 1 patients. Three escalating dose levels will be
evaluated. Each cohort of 6 subjects will enroll sequentially. Each cohort will be
administered PHN121 orally daily for 12 weeks. Subjects will be requested to return on Week
2, Week 4, Week 6, and Week 9 for evaluation and medication. Subjects will also be asked to
return for follow-up evaluation for adverse events on Week 12 and Week 16.
Three doses are planned and include: 2.91, 4.85, and 7.77 g/day. Subjects will be assigned
to a dose level in the order of study entry. Initially, 6 subjects will be enrolled at each
dose level; up to 8 subjects may be assigned to each dose level, depending upon
dose-limiting toxicities (DLTs) seen.
Six subjects will be started on treatment with dose level 1. After the sixth subject
completes 84 days of treatment, if no dose-limiting toxicity occurs, then the next group of
6 subjects will be treated at the next higher dose regimen. If 1 of the 6 initial subjects
experiences a DLT, the cohort of subjects will be expanded to 8 subjects. If fewer than two
DLTs occur in 8 subjects, then the next higher dose group will be initiated. If 2 of the 6
initial subjects or 3 or more (of a cohort of up to 8) subjects experience DLTs, no further
dose escalations will occur; the study will be discontinued and the MTD will have been
exceeded.
No subject may participate in more than 1 cohort.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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