Clinical trial NCT00623649: Safety,Tolerability and Pharmacokinetics of Multiple Ascending Doses of VCH 916 in Subjects With Chronic Hep C Infection
Official title: A Phase 1B, 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HCV Infection
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
Collaborators: name: ViroChem Pharma
name: Duke Clinical Research Institute
First posted: 2008-02-26
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Day 1 to Day 17 visits
Secondary outcomes:
measure: To evaluate the pharmacokinetic (PK) profile of VCH-916 in HCV-infected adults.
timeFrame: Day 1 visit
measure: To establish the relationship between VCH-916 plasma levels and corresponding HCV RNA reduction with the administered dosages of VCH-916 in adults.
timeFrame: Day 1 to Day 4 visits
measure: To study the kinetics of plasma HCV RNA following treatment for up to three(3) days with VCH-916.
timeFrame: Day 1 to Day 4 visits
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The Liver INstitute at Methodist Dallas
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Ottawa
country: Canada
facility: Ottawa Hospital - General Campus
state: Ontario
city: Montréal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Santurce
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
Study officials:
affiliation: Duke Clinical Research Institute
name: John McHutchison, MD
role: PRINCIPAL_INVESTIGATOR
References: