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Safety and Efficacy Study in Hepatitis C Patients With PHN121 (ENCHAMP)

Primary Purpose

Hepatitis C Virus Infection

Status
Terminated
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
PHN121
Sponsored by
PhytoHealth Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C Virus Infection focused on measuring HCV

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Nonsmoking adult subjects age 20 years or above, male or female
  • 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 evidence of significant renal, cardiovascular, hematopoetic, neurological, pulmonary or gastrointestinal pathology, or any other medical reason or disease that might interfere with the study objectives, as determined by the investigator
  • 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

Sites / Locations

  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • PhytoHealth

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lifestyle counseling

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
January 17, 2010
Last Updated
November 24, 2013
Sponsor
PhytoHealth Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01052090
Brief Title
Safety and Efficacy Study in Hepatitis C Patients With PHN121
Acronym
ENCHAMP
Official Title
Safety and Efficacy Study in Non-Responder Hepatitis C Genotype 1 Patients With PHN121
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Terminated
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PhytoHealth Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the safety, tolerability and efficacy of escalating dose of PHN121 when administered orally in non-responder hepatitis C genotype 1 patients
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus Infection
Keywords
HCV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PHN121
Intervention Description
a size 0 hard gel capsule containing 323.6 mg active ingredient, a complex mixture prepared from 5 commonly practiced botanical traditional Chinese medicines
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Nonsmoking adult subjects age 20 years or above, male or female 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 evidence of significant renal, cardiovascular, hematopoetic, neurological, pulmonary or gastrointestinal pathology, or any other medical reason or disease that might interfere with the study objectives, as determined by the investigator 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wan-Long Chuang, M.D., Ph.D.
Organizational Affiliation
Kaohsiung Municipal United Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ming-Lung Yu, M.D., Ph.D.
Organizational Affiliation
Kaohsiung Municipal United Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chia-Yen Dai, M.D., M.S.
Organizational Affiliation
Kaohsiung Municipal United Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
PhytoHealth
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
18666250
Citation
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.
Results Reference
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PubMed Identifier
18605932
Citation
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.
Results Reference
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Safety and Efficacy Study in Hepatitis C Patients With PHN121

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