Safety and Efficacy Study in Hepatitis C Patients With PHN121
NCT ID: NCT01052090
Last Updated: 2013-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
12 participants
INTERVENTIONAL
2009-09-30
2013-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Lifestyle counseling
PHN121
a size 0 hard gel capsule containing 323.6 mg active ingredient, a complex mixture prepared from 5 commonly practiced botanical traditional Chinese medicines
Interventions
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PHN121
a size 0 hard gel capsule containing 323.6 mg active ingredient, a complex mixture prepared from 5 commonly practiced botanical traditional Chinese medicines
Eligibility Criteria
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Inclusion Criteria
* Non-Responder HCV patient who failed to achieve sustained viral response (SVR), either do not respond or relapse, to prior 24-week interferon based therapy
* Any antiviral agent discontinued at least 4 weeks before the screening visit.
* Presence of anti-HCV in serum
* Serum and PCR positive for HCV-RNA\*1 (Genotype 1)
* Elevated ALT (\> 1.3 x upper limit of normal) during last 6 months and (1.3 x to 10 x upper limit of normal) during the screening phase
* No evidence showing liver cirrhosis or hepatocellular carcinoma\*2
* Hematological, biochemical and serologic criteria at the screening phase is within normal limits (WNL):
* Hemoglobin values of \> 12gm/dl for females and \> 13gm/dl for males
* WBC \> 3,000/mm3
* Neutrophil \> 1,500/mm3
* Platelets count \> 90,000/mm3
* Normal PT (INR\< 1.2)
* Total bilirubin \< 2 mg/dl
* Albumin, WNL
* Serum creatinine, WNL
* Written informed consent
Exclusion Criteria
* Has participated in other investigational trials within 28 days prior to study enrollment
* Has taken botanical medications\*3 within 28 days prior to study enrollment
* Has an surgery within 28 days prior to study enrollment
* Has been diagnosed with any other cause for the liver disease other than chronic hepatitis C including the following conditions:
* Co-infection with HBV
* Hemochromatosis
* Alpha-1 antitrypsin deficiency
* Wilson's disease
* Autoimmune hepatitis
* Alcoholic liver disease
* Drug-related liver disease
* Other liver disease that was considered by the principal investigator
* Has been test positive for HIV
* Has been diagnosed with poor-controlled Diabetes Mellitus (HbA1C \> 9.0%)
* Active alcohol abuse of daily intake \> 30 g for male and \> 20 g for female within the previous 1 year
* Active substance abuse, such as inhaled or injection drugs within the previous 1 year \*4
* Female subjects of child bearing potential who are pregnant, nursing, do not agree to practice effective birth control during the time period from 14 days before administration of study drug to 28 days after administration of study drug
20 Years
ALL
No
Sponsors
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PhytoHealth Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Wan-Long Chuang, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Kaohsiung Municipal United Hospital
Ming-Lung Yu, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Kaohsiung Municipal United Hospital
Chia-Yen Dai, M.D., M.S.
Role: PRINCIPAL_INVESTIGATOR
Kaohsiung Municipal United Hospital
Locations
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Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
PhytoHealth
Taipei, , Taiwan
Countries
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References
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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.
Other Identifiers
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PH-CP015
Identifier Type: -
Identifier Source: org_study_id