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

Fundacion Clinic per a la Recerca Biomédica

Status and phase: Withdrawn; Phase 3

Conditions: Liver Transplantation; Hepatitis C

Treatments: Drug: Elbasvir 50 mg/d; Drug: Elbasvir 50 mg/day; Drug: Ribavirin 1200 mg/day; Drug: Grazoprevir 100 mg/day

Study type: Interventional

Funder types: Other

Identifiers

NCT02890719

2015-005453-13 (EudraCT Number)

EGRADICATE

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Genotype 1B

Experimental group

Description:

treatment 12 weeks

Treatment:

Drug: Grazoprevir 100 mg/day

Drug: Elbasvir 50 mg/d

Drug: Grazoprevir 100 mg/day

Genotype 1A and 4

Experimental group

Description:

treatment 16 weeks

Treatment:

Drug: Grazoprevir 100 mg/day

Drug: Ribavirin 1200 mg/day

Drug: Elbasvir 50 mg/day

Drug: Grazoprevir 100 mg/day