Status:
TERMINATED
Interaction Between Paroxetine and Telaprevir
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Janssen, LP
Conditions:
Hepatitis C Infection
Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Hepatitis C (HCV) infected patients are often in need for an antidepressant. The introduction of Direct Acting Antivirals such as telaprevir has greatly improved treatment outcome of HCV infected pati...
Detailed Description
HCV infected patients are often in need for an antidepressant. Inadequate treatment of depression during HCV treatment has a negative effect on adherence to HCV treatment, with suboptimal response as ...
Eligibility Criteria
Inclusion
- Subject is at least 18 and not older than 65 years at screening.
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
- Subject has a chronic HCV infection with genotype 1.
- Subject is eligible for telaprevir containing HCV treatment.
- Subject is on a stable dose of 20 mg paroxetine once daily for at least 4 weeks.
Exclusion
- Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
- Pregnant female (as confirmed by a human chorionic gonadotropin (HCG) test performed less than 6 weeks before Day -1) or breast-feeding female. Female subjects of childbearing potential without adequate contraception, e.g. hysterectomy, bilateral tubal ligation, (non-hormonal) intrauterine device, total abstinence, double barrier methods, or two years post-menopausal. They must agree to take precautions in order to prevent a pregnancy throughout.
- Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
- Inability to understand the nature and extent of the trial and the procedures required.
- Participation in a drug trial within 60 days prior to the first dose of telaprevir.
- Use of relevant concomitant medication, as assessed by a hospital pharmacist (member of the study team).
- Hemoglobin \< 12 g/dL (females) or \< 13 g/dL (males) (7.4 respectively 8.0 mM).
- Poor- or ultrarapid metabolizer CYP2D6 (based on genetic testing)
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01841502
Start Date
May 1 2013
End Date
September 1 2014
Last Update
December 8 2020
Active Locations (7)
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1
Academic Medical Centre Amsterdam
Amsterdam, Netherlands
2
GGD Amsterdam
Amsterdam, Netherlands
3
Reinier de Graaf Groep
Delft, Netherlands
4
University Medical Centre Groningen
Groningen, Netherlands