Safety and Efficacy Study in Hepatitis C Patients With PHN121

NCT01052090 | Terminated Phase 1 DMC

• 1 other identifier: PH-CP015
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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

Conditions

Hepatitis C Virus Infection

Keywords

HCV

Outcome Measures

Primary Outcomes (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).

  12-week treatment; 4-week safety followup

Secondary Outcomes (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.

  12-week treatment; 4-week safety followup

Study Arms (1)

Lifestyle counseling

EXPERIMENTAL

Drug: PHN121

Interventions

PHN121 DRUG

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

Lifestyle counseling

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%)

Sponsors & Collaborators

• PhytoHealth Corporation: lead

Study Sites (2)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

PhytoHealth

Taipei, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 18666250 BACKGROUND

• 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.

  PMID: 18605932 BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2010
• First Posted: January 20, 2010
• Study Start: September 1, 2009
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 26, 2013

Record last verified: 2010-01

Locations

TW (2)