NCT01052090|TerminatedPhase 1/2DMC
Safety and Efficacy Study in Hepatitis C Patients With PHN121
ENCHAMP
Safety and Efficacy Study in Non-Responder Hepatitis C Genotype 1 Patients With PHN121
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Sponsor study identifier
interventional
12
1 country
2
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To evaluate the safety, tolerability and efficacy of escalating dose of PHN121 when administered orally in non-responder hepatitis C genotype 1 patients
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
January 17, 2010
Actual (reported)January 20, 2010
Actual (reported)November 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
12-week treatment; 4-week safety followup
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.
12-week treatment; 4-week safety followup
a size 0 hard gel capsule containing 323.6 mg active ingredient, a complex mixture prepared from 5 commonly practiced botanical traditional Chinese medicines
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
PhytoHealth
Taipei, Taiwan
Dai CY, Chuang WL, Huang JF, Hsieh MY, Yu ML. Rapid virological response in hepatitis C virus genotype 1 and early ribavirin exposure. Hepatology. 2008 Aug;48(2):692-3; author reply 693-4. doi: 10.1002/hep.22409. No abstract available.
Huang JF, Dai CY, Lin YY, Yu ML, Liu SF, Lin IL, Hsieh MY, Lee LP, Lin ZY, Chen SC, Hsieh MY, Chang WY, Chuang WL. Performance characteristics of a real-time RT-PCR assay for quantification of hepatitis C virus RNA in patients with genotype 1 and 2 infections. Clin Chem Lab Med. 2008;46(4):475-80. doi: 10.1515/CCLM.2008.082.
Wan-Long Chuang, M.D., Ph.D.
Kaohsiung Municipal United Hospital
Ming-Lung Yu, M.D., Ph.D.
Kaohsiung Municipal United Hospital
Chia-Yen Dai, M.D., M.S.
Kaohsiung Municipal United Hospital
12 participants (actual enrollment reported by the registry).
First Submitted
January 17, 2010
First Posted
January 20, 2010
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
November 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 26, 2013
Record last verified: 2010-01
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Source: ClinicalTrials.gov.
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