A Study to Evaluate the Safety and Effect of three experimental drugs ABT-450, ABT-267 and ABT-333 with Ritonavir and sometimes with Ribavirin in people who have had a Transplant and have Hepatitis C Virus (HCV) infection.
- Conditions
- Chronic Hepatitis C InfectionMedDRA version: 17.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2012-004792-39-DE
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 175
1. Male or female, at least 18 years of age at the time of screening.
2. Currently taking an immunosuppressant regimen based on either tacrolimus or cyclosporine.
Corticosteroids such as prednisone or prednisolone are permitted as components of the immunosuppressant regimen providing the dose is not more than 10 mg / day.
3. HCV IFN therapy treatment-naïve or experienced, either pre or post liver or renal transplant.
4. Screening HCV genotype testing indicating infection with genotype 1 HCV only.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
1. Use of everolimus or sirolimus as part of the immunosuppressive regimen within 2 months of Screening Visit.
2. Use of any medications listed below as well as those that are contraindicated for use with either ritonavir or RBV within 2 weeks prior to study drugs administration or 10 half-lives (if known), whichever is longer, including but not limited to:
Alfuzosin
Amiodarone
Astemizole
Atorvastatin
Carbamazepine
Conivaptan
Enzalutamide
Systemic estrogen-containing medications
Etravirine
Fusidic acid
Gemfibrozil
Pimozide
Posaconazole
Quetiapine
Quinidine
Rifampin
Salmeterol
Cisapride
Clarthromycin
Cobicistat
Colchicine in patients with renal or hepatic impairment
Ergot derivatives (Dihydroergotamine, Ergotamine, Ergonovine,
Methylergometrine)Efavirenz
Indinavir
Itraconazole
Ketoconazole
Lopinavir/ritonavir
Lovastatin
Midazolam (oral)Mitotane
Nevirapine
Phenobarbital
Phenytoin
Saquinavir
Sildenafil*
Simvastatin
St. John's Wort
Telithromycin
Terfenadine
Ticagrelor
Tipranavir
Triazolam
Voriconazole
* When used for the treatment of pulmonary arterial hypertension.Note: Not all medications contraindicated with ritonavir and ribavirin arelisted above. Refer to themost current package inserts or product labelling of ritonavir and ribavirin for a complete list ofcontraindicated medications.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objectives of this study are to assess safety and efficacy (the percentage of subjects achieving a 12-week sustained virologic response, SVR12 (HCV ribonucleic acid [RNA] < lower limit of quantification [LLOQ] 12 weeks following treatment) of coformulated ABT-450/r and ABT-267 (ABT-450/r/ABT-267) and ABT-333 coadministered with or without RBV for 24 weeks in HCV genotype 1-infected adult liver transplant recipients.;Secondary Objective: The secondary objectives of this study are to assess the percentage of subjects achieving a 24-week sustained virologic response, SVR24 (HCV RNA < LLOQ 24 weeks following treatment), the percentage of subjects with virologic failure during treatment, and the percentage of subjects with relapse post-treatment.;Primary end point(s): The primary endpoint is the percentage of subjects with SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drugs).;Timepoint(s) of evaluation of this end point: 12 weeks after last dose of study drugs
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary endpoints are:<br>? The percentage of subjects with SVR24 (HCV RNA < LLOQ 24 weeks after the last actual dose of study drugs);<br>? The percentage of subjects with virologic failure during treatment;<br>? The percentage of subjects with post-treatment relapse.;Timepoint(s) of evaluation of this end point: Treatment Day 1 to end of treatment and end of treatment to 48 weeks post treatment.