EUCTR2012-004792-39-GBActive, not recruitingPhase 1
Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of the Combination of ABT-450/Ritonavir/ABT-267 With ABT-333 and With or Without RBV in HCV Genotype 1 and ABT-450/r/ABT-267 with RBV in HCV GT4-Infected Adult Liver or Renal Transplant Recipients With Hepatitis C Virus (HCV) Infection (CORAL-I) - Coral-I
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 129
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
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:
- •Atorvastatin
- •Carbamazepine
- •Enzalutamide
- •Ethinyl estradiol-containing medications
- •Fusidic acid
- •Gemfibrozil
- •Posaconazole
- •Clarthromycin
- •Colchicine in patients with renal or hepatic impairment
- •Ergot derivatives (Dihydroergotamine, Ergotamine, Ergonovine, Methylergometrine)
- •Itraconazole
- •Ketoconazole
- •Lopinavir/ritonavir
- •Midazolam (oral)
- •Phenobarbital
- •Sildenafil*
- •Simvastatin
- •St. John's Wort
- •Telithromycin
- •Terfenadine
- •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.
Investigators
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