Safety and Efficacy Study in Hepatitis C Patients With PHN121 (ENCHAMP)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy Study in Non-Responder Hepatitis C Genotype 1 Patients With PHN121|
- Safety: Safety assessments will include ALT, aspartate aminotransferase (AST), other clinical laboratory tests, HCV RNA quantitation, vital signs, physical examinations, concomitant medications, and adverse events (AEs). [ Time Frame: 12-week treatment; 4-week safety followup ] [ Designated as safety issue: Yes ]
- Efficacy: Efficacy will be assessed by evaluating the plasma concentrations of ALT and viral load through calculating the percent change from Baseline on a per-subject and by-cohort basis, normalizing to the baseline measurement. [ Time Frame: 12-week treatment; 4-week safety followup ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
|Experimental: Lifestyle counseling||
a size 0 hard gel capsule containing 323.6 mg active ingredient, a complex mixture prepared from 5 commonly practiced botanical traditional Chinese medicines
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052090
|Kaohsiung Medical University Chung-Ho Memorial Hospital|
|Principal Investigator:||Wan-Long Chuang, M.D., Ph.D.||Kaohsiung Municipal United Hospital|
|Principal Investigator:||Ming-Lung Yu, M.D., Ph.D.||Kaohsiung Municipal United Hospital|
|Principal Investigator:||Chia-Yen Dai, M.D., M.S.||Kaohsiung Municipal United Hospital|