Clinical trial NCT02890719: Pilot Study Evaluate Efficacy of Grazoprevir + Elbasvir for 12 or 16 Weeks in Liver Transplant Recipients.
Official title: Pilot Study Evaluate Efficacy of Grazoprevir + Elbasvir for 12 or 16 Weeks in Liver Transplant Recipients.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Liver Transplantation
Hepatitis C
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Sustained virological response
timeFrame: 12 weeks post-treatment
Secondary outcomes:
measure: Sustained virological response
timeFrame: 4 weeks and 24 weeks post-treatment
measure: To evaluate the beneficial effects of antiviral therapy on renal function.
timeFrame: 24 weeks post-treatment
measure: To assess the impact of therapy in kidney function.
timeFrame: 24 weeks post-treatment
measure: Tolerability of this combination in liver transplant recipients.
timeFrame: Every visit
Other outcomes:
Locations:
Study officials:
References: