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Safety,Tolerability and Pharmacokinetics of Multiple Ascending Doses of VCH 916 in Subjects With Chronic Hep C Infection
This study is currently recruiting participants.
Verified by ViroChem Pharma, August 2008
First Received: February 14, 2008   Last Updated: August 22, 2008   History of Changes
Sponsors and Collaborators: ViroChem Pharma
Duke University
Information provided by: ViroChem Pharma
ClinicalTrials.gov Identifier: NCT00623649
  Purpose

The purpose of this study is to determine whether a 3-day course of therapy with orally administered VCH-916 given at different dosages can effectively reduce the amount of circulating virus (i.e., viral load) in patients with early-stage chronic hepatitis C-infection. This study will also evaluate the safety and tolerability of treatment with VCH-916. Blood samples will also be taken to measure the levels of VCH-916 present in plasma at various time points during the treatment period.


Condition Intervention Phase
HCV Infection
Drug: VCH 916
Drug: Placebo
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment
Official Title: A Phase IB, Multicentre, Randomized, Double-Blinded, and PLacebo-Controlled Study of the Antiviral Activity, Safety, Tolerability, and PK of Multiple Ascending Doses of VCH-916 in the Treatment Naive or Experienced Subjects With Chronic Hep C-Infection.

Further study details as provided by ViroChem Pharma:

Primary Outcome Measures:
  • The primary objective of this trial is to assess the antiviral activity, safety, and tolerability of VCH-916 monotherapy in adult subjects with chronic HCV-infection. [ Time Frame: Day 1 to Day 17 visits ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the pharmacokinetic (PK) profile of VCH-916 in HCV-infected adults. [ Time Frame: Day 1 visit ] [ Designated as safety issue: No ]
  • To establish the relationship between VCH-916 plasma levels and corresponding HCV RNA reduction with the administered dosages of VCH-916 in adults. [ Time Frame: Day 1 to Day 4 visits ] [ Designated as safety issue: No ]
  • To study the kinetics of plasma HCV RNA following treatment for up to three(3) days with VCH-916. [ Time Frame: Day 1 to Day 4 visits ] [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: November 2007
Estimated Study Completion Date: October 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cohort 1 to 4: Experimental
This will be a 4 doses escalation study comparing VCH 916 to Placebo treatment.
Drug: VCH 916
Dose escalation study with a full review of all safety data following each cohort.
Drug: Placebo
Dose escalation study with a full review of all safety data following each cohort.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females 18 to 60 years of age
  • No evidence of cirrhosis or have liver fibrosis corresponding to Metavir Stages 0 to 3
  • Subject's liver disease is stable with ALT values < 5 X ULN
  • Serologic evidence of detectable plasma HCV-RNA of ≥ 100,000 IU/ml at screening
  • Documented HCV Genotype 1 chronic hepatitis C.
  • Judged to be in good health on the basis of medical history and physical examination
  • All other hematology and clinical chemistry must be within normal limits or show no clinically significant abnormalities.
  • Be treatment-naïve or experienced.
  • For female subjects, must not be pregnant or breastfeeding and must be postmenopausal, surgically sterile, abstinent, or using two proven methods of birth control.
  • Sexually active male subjects, must be practicing acceptable methods of contraception during the treatment period
  • Female subjects of childbearing potential must have a negative serum ß-HCG pregnancy test at screening and a negative urine pregnancy test on Day 1 before the first dose of study drugs.
  • Agree not to participate in other clinical trials for the duration of his/her participation in this clinical trial.

Exclusion Criteria:

  • Be participating in any other clinical studies or have participated in another clinical trial within the last 30 days before study drug administration, or participation in more than 2 drug studies in the last 12 months (exclusive of the current study).
  • Be actively taking hard illicit drugs within 12 months prior to the screening visit or alcohol.
  • Have a Child-Pugh score > than 5.
  • Have evidence of liver cirrhosis including histological evidence of hepatic cirrhosis on any liver biopsy.
  • Have any cause of liver disease other than chronic hepatitis C-infection
  • Active or malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma).
  • Have clinically significant electrocardiogram abnormalities and/or cardiovascular dysfunction within the previous 6 months
  • Have significant renal, pulmonary, gastrointestinal absorption, or neurological diseases, or neoplasia.
  • Have a history of psychiatric disorders determined by the investigator to contraindicate therapy.
  • Have uncontrolled Type 1 or Type II diabetes.
  • Antinuclear antibody titer ≥1:320.
  • Coinfection with hepatitis B and/or HIV 1 or HIV 2.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623649

Contacts
Contact: John McHutchison, MD 919-668-7177 mchut001@mc.duke.edu

Locations
United States, Florida
Center for Liver Diseases, Miller School of Medicine, University of miami Not yet recruiting
Miami, Florida, United States, 33136
Contact: Chakradhar Reddy, MD     305-243-4615     chakram_reddy@hotmail.com    
Principal Investigator: Chakradhar Reddy, MD            
United States, Texas
Alamo Medical Research Recruiting
San Antonio, Texas, United States, 78215
Contact: Eric Lawitz, MD     210-253-3426 ext 261     lawitz@alamomedicalresearch.com    
Principal Investigator: Eric Lawitz, MD            
The Liver INstitute at Methodist Dallas Recruiting
Dallas, Texas, United States, 75208
Contact: Reem Ghalib, MD     214-947-4449     reemghalib@mhd.com    
Principal Investigator: Reem Ghalib, MD            
Canada, Ontario
Ottawa Hospital - General Campus Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Curtis Cooper, MD     613-737-8924     ccooper@ottawahospital.on.ca    
Principal Investigator: Curtis Cooper, MD            
Canada, Quebec
Royal Victoria Hospital Recruiting
Montréal, Quebec, Canada, H3A 1A1
Contact: Richard Lalonde, MD     514-934-1934 ext 36347     richard.lalonde@muhc.mcgill.ca    
Principal Investigator: Richard Lalonde, MD            
Puerto Rico
Fundacion de Investigacion de Diego Recruiting
Santurce, Puerto Rico, 00909
Contact: Maribel Rodriguez-Torres, MD     787-722-1248     rodztorres@coqui.net    
Principal Investigator: Maribel Rodriguez-Torres, MD            
Sponsors and Collaborators
ViroChem Pharma
Duke University
Investigators
Principal Investigator: John McHutchison, MD Duke University
  More Information

No publications provided

Responsible Party: ViroChem Pharma Inc. ( Louise Proulx, Vice President Product Development )
Study ID Numbers: VCH 916-103
Study First Received: February 14, 2008
Last Updated: August 22, 2008
ClinicalTrials.gov Identifier: NCT00623649     History of Changes
Health Authority: United States: Food and Drug Administration;   Canada: Health Canada

Study placed in the following topic categories:
Antiviral Agents

Additional relevant MeSH terms:
Communicable Diseases
Infection

ClinicalTrials.gov processed this record on September 03, 2009