PILOT STUDY TO EVALUATE THE EFFICACY AND TOLERABILITY OF GRAZOPREVIR + ELBASVIR FOR 12 OR 16 WEEKS IN LIVER TRANSPLANT RECIPIENTS

Phase 1

• Conditions: HCV infection and liver trasplant; MedDRA version: 19.0Level: LLTClassification code 10019752Term: Hepatitis C virus (HCV)System Organ Class: 100000004848; MedDRA version: 19.0Level: LLTClassification code 10024716Term: Liver transplantationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-005453-13-ES
• Lead Sponsor: Fundació clínic per a la Recerca Biomèdica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-04
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

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

Inclusion Criteria

-Age between 18 and 78 year-old.
-Previous liver transplantation (more than 6 months).
-Genotype 1 and 4 infection.
-Hepatitis C recurrence defined by the presence of abnormal liver function tests, positive HCV-RNA, histological signs of hepatitis C recurrence.
-Viral load = 10000 UI/mL.
-Immunosuppression with tacrolimus and/or mycophenolate (Prednisone use is allowed at low dose, =10mg/d).
-Treatment naïve or treatment experienced (Peg-RBV or triple therapy)
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 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

-Genotype 2, 3, 5 or 6 infection.
-Decompensated cirrhosis defined by the presence of actual or previous history of clinical decompensation including ascites, hepatic encephalopathy, variceal bleeding or spontaneous bacterial peritonitis, or a Child-Pugh B or C.
-Hepatocellular carcinoma after liver transplantation.
-Total bilirubin > 3 mg/dL.
-Immunosuppression with cyclosporine or an mTOR inhibitor (everolimus or sirolimus).
-Severe extrahepatic diseases: cardiovascular, respiratory, cerebrovascular and poorly controlled diabetes.
-Platelets < 75 x 109 cells/L.
-Neutrophil count < 0.5 x 109 cells/L.
-Hemoglobin < 9 g/dL.
-Albumin < 3g/dL.
-HIV infection.
-Hepatitis B infection.
-Active intake of toxic amounts of alcohol or recreational drugs.
-Females who are pregnant, become to be pregnant or breastfeeding or males whose partners are pregnant, become to be pregnant or breastfeeding.
-Intake of disallowed medications including(but not limited to):
1.Antibiotics: clarithromycin, erythromycin, telithromycin, nafcillin, rifampin
2.Antifungals: itraconazole, ketoconazole, voriconazole
3.Antihypertensives: nifedipine
4.Anticonvulsants: carbamazepine, phenytoin, phenobarbital
5.Bosentan
6.Modafinil
7.St.Jonh’s Wort
8.Immunosuppressants: cyclosporin, everolimus, sirolimus
9.Diabetes agents: glibenclamide, glyburide
10.Lipid lowering agents: gemfibrozil
11.Eltrombopag
12.Lapatinib
13.HIV medications: efavirenz, etravirine, all ritonavir boosted and unboosted HIV protease inhibitors
14.Statins: simvastatin, fluvastatin, rosuvastatin at doses greater than 10 mg/d, atorvastatin at doses greater than 10 mg/d.

Study & Design

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