A Study to Evaluate the Safety and Effect of three 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.

Phase 1

• Conditions: Chronic Hepatitis C Infection; MedDRA version: 20.0 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-004792-39-GB
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-06
• Study Completion: 2017-07-13
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 129

Inclusion Criteria

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 or 4 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 165
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

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
Ethinyl estradiol-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 are listed above. Refer to the most current package inserts or product labelling of ritonavir and ribavirin for a complete list of contraindicated medications.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified