Pilot Study Evaluate Efficacy of Grazoprevir + Elbasvir for 12 or 16 Weeks in Liver Transplant Recipients.

• Status: Withdrawn
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Pilot, single center, open-label study to evaluate the efficacy and tolerability of Grazoprevir and Elbasvir in HCV GT1 and 4 liver transplant recipients.30 liver transplant recipients with hepatitis C recurrence.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica
• Treatments: Grazoprevir; Ribavirin

Criteria

Inclusion Criteria:

• Age between 18 and 78 year-old.

• Previous liver transplantation(more than 6 month).

• Genotype 1 and 4 infection.

• Hepatitis C recurrence defined by the presence of abnormal liver function test, positive HCV-RNA, histological signs of hepatitis C recurrence.

• Viral load ≥10000UI/mL.

• Immunosuppression with tacrolimus and/or mycophenolate (Prednisone use is allowed at low dose, ≤10 mg/d).

• Treatment naïve or treatment experienced (Peg-RBV or triple therapy).

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.