See comments at the Dutch section
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
See comments at the Dutch section
Secondary outcome
See comments at the Dutch section
Background summary
See comments at the Dutch section
Study objective
See comments at the Dutch section
Study design
See comments at the Dutch section
Intervention
See comments at the Dutch section
Study burden and risks
See comments at the Dutch section
Dr. Paul Janssenweg 150
5026 RH Tilburg
Nederland
Dr. Paul Janssenweg 150
5026 RH Tilburg
Nederland
Listed location countries
Age
Inclusion criteria
Healthy subjects aged between 18 and 55 years.
Non-smokers for at least 3 months prior to selection
Normal weight as defined by a BMI of 18.0 to 30.0 kg/m2. Normal 12-lead ECG
Patients:
Subjects aged between 18 and 70 years, extremes included
Able to comply with protocol requirements and having good accessible veins.
Subjects with chronic Genotype 1 HCV infection, non-responders to previous treatment regimens (being interferon/ ribavirin or pegylated interferon/ribavirin)
Exclusion criteria
Past history of heart arrhythmias or having baseline prolongation of QTc interval > 450 ms, history of risk factors for Torsade de Pointes syndrome or evidence of cardiomyopathy as evidenced by a grade 1 or higher decrease in EF/SF.
Female, except if postmenopausal since more than 2 years, or post-hysterectomy, or post tubal ligation.
Confirmed Hepatitis A, B, or C infection, or cancer or HIV/AIDS.
Participation in an investigational drug trial within 30 days prior to the first intake of trial medication.
Donation of blood or plasma within 60 days preceding the first intake of trial medication.
Patients:
Subjects co-infected with HIV-1, HIV-2 or any hepatitis infection other than HCV.
Male subjects with female partners of childbearing potential not agreeing to use a reliable birth control method for 90 days after the last dosing in the study.
Subjects on non stable methadone use, on non stable anti-hypertensive treatment or on non stable antidepressant treatment.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2006-006455-12-NL |
CCMO | NL15888.056.06 |