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Hepatitis C Virus InfectionPhase 1/2ENCHAMPNCT01052090

Safety and Efficacy Study in Hepatitis C Patients With PHN121

A Phase 1/2 study testing PHN121 in people with Hepatitis C Virus Infection, run by PhytoHealth Corporation at 2 sites in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 20 years and older
Conditions the study is for
Hepatitis C Virus Infection
What is being tested?
PHN121
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesTaiwan
Study dates
Sep 2009to Dec 2013
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

  • PhytoHealth

    Taipei

Other trials in Taiwan

About this study

Official title: Safety and Efficacy Study in Non-Responder Hepatitis C Genotype 1 Patients With PHN121

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

Read the 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.

Being tested
PHN121
Keywords
HCV
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PHN121Drug

    a size 0 hard gel capsule containing 323.6 mg active ingredient, a complex mixture prepared from 5 commonly practiced botanical traditional Chinese medicines

Study groups in NCT01052090
Study groupRoleWhat they receive
Lifestyle counselingExperimentalNot described
Receives: Drug: PHN121

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 12-week treatment; 4-week safety followup

Secondary outcomes (1)

  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.

    Measured: 12-week treatment; 4-week safety followup

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2010 (estimated)
  2. Study startSep 2009
  3. Primary completionNov 2013 (estimated)
  4. Study completionDec 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01052090
Sponsor's protocol ID
PH-CP015
Acronym
ENCHAMP
Status last verified
Jan 2010
First submitted
17 Jan 2010
Last updated
26 Nov 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18666250

  • 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.

    PubMed 18605932

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PHN121 in people with Hepatitis C Virus Infection, run by PhytoHealth Corporation at 2 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01052090, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2013.

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