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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
PhytoHealth Corporation
ClinicalTrials.gov Identifier:
NCT01052090
First received: January 17, 2010
Last updated: November 24, 2013
Last verified: January 2010
  Purpose

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


Condition Intervention Phase
Hepatitis C Virus Infection
Drug: PHN121
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by PhytoHealth Corporation:

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). [ Time Frame: 12-week treatment; 4-week safety followup ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 12-week treatment; 4-week safety followup ] [ Designated as safety issue: No ]

Enrollment: 12
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)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052090

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

Publications:
Responsible Party: PhytoHealth Corporation
ClinicalTrials.gov Identifier: NCT01052090     History of Changes
Other Study ID Numbers: PH-CP015
Study First Received: January 17, 2010
Last Updated: November 24, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by PhytoHealth Corporation:
HCV

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

ClinicalTrials.gov processed this record on November 27, 2014