A Study to Assess the Anti-viral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 in Participants Infected With Hepatitis C-Virus (HCV)
An Open-label Trial in Genotype 2, 3, 4, 5 and 6 Hepatitis C-infected Subjects to Evaluate the Antiviral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 Following 7 Days Once Daily Dosing as Monotherapy.
2 other identifiers
interventional
37
3 countries
10
Brief Summary
The purpose of this study is to assess anti-viral activity (inhibition of viral growth) of TMC435350 in genotype 2,3,4,5 and 6 hepatitis C virus infected participants who have never received treatment for their hepatitis C infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2009
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2008
CompletedFirst Posted
Study publicly available on registry
December 22, 2008
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
July 28, 2014
CompletedJuly 28, 2014
July 1, 2014
8 months
December 18, 2008
December 24, 2013
July 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels
The table below shows the mean changes from baseline in HCV RNA values (log10 IU/mL) per genotype on Day 3 and Day 7 during the TMC435 treatment period.
Baseline, Day 3, and Day 7
Secondary Outcomes (13)
Number of Participants With a Decrease From Baseline of Greater Than or Equal to 2 log10 IU/mL in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During the TMC435 Treatment Period
Baseline, Day 3, Day 5 and Day 7
Number of Participants With Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Below the Limit of Quantification (Less Than 25 IU/mL) and Limit of Detection (Less Than 25 IU/mL Undetectable) During the TMC435 Treatment Period
Baseline, Day 3, Day 5 and Day 7
Number of Participants Who Experienced Viral Breakthrough During TMC435 Treatment Period
During the 7-day of TMC435 treatment period
Predose Plasma Concentration (C0h) of TMC435
Predose on Day 7
Minimum Plasma Concentration (Cmin) of TMC435
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
- +8 more secondary outcomes
Study Arms (5)
Genotype 2
EXPERIMENTALParticipants with chronic genotype 2 hepatitis C virus (HCV) infection
Genotype 3
EXPERIMENTALParticipants with chronic genotype 3 HCV infection
Genotype 4
EXPERIMENTALParticipants with chronic genotype 4 HCV infection
Genotype 5
EXPERIMENTALParticipants with chronic genotype 5 HCV infection
Genotype 6
EXPERIMENTALParticipants with chronic genotype 6 HCV infection
Interventions
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
Eligibility Criteria
You may qualify if:
- Participants with documented chronic genotype 2, 3, 4, 5 or 6 hepatitis C virus (HCV) infection
- Participants who have never received treatment for their HCV infection
- Participants with either no cirrhosis or up to Child Pugh A liver disease
- Participants with plasma HCV genotype level of more than or equal to 100, 000 IU/mL at screening
You may not qualify if:
- Evidence of Child Pugh B or C liver disease at screening, decompensated liver disease defined as prior or current history of ascities, hepatic encephalopathy, esophageal or gastric varices
- Participants with diagnosed or suspected hepatocellular carcinoma
- Participants coinfected with human immunodeficiency virus type 1 or 2, or hepatitis A or B virus infection or active tuberculosis at screening
- Participants with any active clinically significant disease, or medical history or physical examination or electrocardiogram findings during screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Unknown Facility
Bruges, Belgium
Unknown Facility
Brussels, Belgium
Unknown Facility
Ghent, Belgium
Unknown Facility
Leuven, Belgium
Unknown Facility
Berlin, Germany
Unknown Facility
Frankfurt, Germany
Unknown Facility
Freiburg im Breisgau, Germany
Unknown Facility
Hanover, Germany
Unknown Facility
Bangkok, Thailand
Unknown Facility
Chiang Mai, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical DVLP Manager
- Organization
- Janssen Research & Development United States
Study Officials
- STUDY DIRECTOR
Tibotec Pharmaceuticals, Ireland Clinical Trial
Tibotec Pharmaceuticals, Ireland
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2008
First Posted
December 22, 2008
Study Start
March 1, 2009
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
July 28, 2014
Results First Posted
July 28, 2014
Record last verified: 2014-07