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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01052090
Recruitment Status : Terminated
First Posted : January 20, 2010
Last Update Posted : November 26, 2013
Information provided by (Responsible Party):
PhytoHealth Corporation

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

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Drug: PHN121 Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Study in Non-Responder Hepatitis C Genotype 1 Patients With PHN121
Study Start Date : September 2009
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lifestyle counseling Drug: 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

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01052090

Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan
Taipei, Taiwan
Sponsors and Collaborators
PhytoHealth Corporation
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

Responsible Party: PhytoHealth Corporation Identifier: NCT01052090     History of Changes
Other Study ID Numbers: PH-CP015
First Posted: January 20, 2010    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: January 2010

Keywords provided by PhytoHealth Corporation:

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections