Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
3 participants
INTERVENTIONAL
2013-05-31
2014-09-30
Brief Summary
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For a number of reasons, paroxetine may be a good candidate for use together with telaprevir-containing HCV treatment.
The interaction between paroxetine and telaprevir has not been studied before.
Detailed Description
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The introduction of Direct Acting Antivirals such as telaprevir has greatly improved treatment outcome of HCV infected patients. Telaprevir, however, causes some significant drug-drug interactions and hence co-administration of other medications should preferably only be done based on clinical evidence that such a combination is safe.
Telaprevir has been studied with one antidepressant, escitalopram: plasma concentrations of the antidepressant were reduced by 35% and without dose adjustment this may lead to inadequate treatment of depressive symptoms. Dose titration of escitalopram may be needed but it may take several weeks before a patient has reached a therapeutic dose.
There is a need for more data on telaprevir drug interactions with other antidepressants. First, the data above show that a negative interaction occurs with escitalopram and dose-titration of the antidepressant may take too long to prevent the (re-)occurrence of depressive symptoms. Second, not all patients benefit from escitalopram and those with (prior) treatment failure on escitalopram may require an alternative agent. Third, although escitalopram is generally well-tolerated, side effects may occur and necessitate treatment discontinuation. Finally, especially in the previous intravenous drug users on methadone, escitalopram might not be the antidepressant of choice, since escitalopram as well as methadone are drugs that can lead to QTc interval prolongation and have a risk of Torsades de Pointes.
For a number of reasons, paroxetine may be a good candidate for use together with telaprevir-containing HCV treatment. First, paroxetine has been shown to prevent depressive symptoms in patients initiating HCV treatment with elevated depressive symptoms at baseline. Second, paroxetine is an inhibitor of and is metabolized by CYP2D6 while telaprevir is an inhibitor of and is metabolized by CYP3A, and therefore no drug-drug interaction is expected. Third, paroxetine is one of the most widely prescribed antidepressants with a well-established efficacy and safety profile.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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paroxetine alone
paroxetine 20 mg tablet once daily oral
Paroxetine
paroxetine 20 mg once daily
paroxetine + telaprevir
paroxetine 20 mg tablet once daily + telaprevir 1125 mg (3 tablets 375mg) twice daily oral
Paroxetine
paroxetine 20 mg once daily
telaprevir
telaprevir 1125 mg twice daily
Interventions
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Paroxetine
paroxetine 20 mg once daily
telaprevir
telaprevir 1125 mg twice daily
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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)
18 Years
65 Years
ALL
No
Sponsors
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Janssen, LP
INDUSTRY
Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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David Burger, PharmD, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Academic Medical Centre Amsterdam
Amsterdam, , Netherlands
GGD Amsterdam
Amsterdam, , Netherlands
Reinier de Graaf Groep
Delft, , Netherlands
University Medical Centre Groningen
Groningen, , Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, , Netherlands
Maasstadziekenhuis
Rotterdam, , Netherlands
University Medical Centre Utrecht
Utrecht, , Netherlands
Countries
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Related Links
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dissertation page 185-192
Other Identifiers
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AKF UMCN 12.02
Identifier Type: -
Identifier Source: org_study_id