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

Hepatitis C Clinical Trial

— EGRADICATE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02890719
• Other study ID #: EGRADICATE
• Status: Withdrawn
• Phase: Phase 3
• First received: August 24, 2016
• Last updated: November 2, 2017
• Start date: May 2, 2017
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 78 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis C
• Liver Transplantation

Intervention

Drug:
• Grazoprevir 100 mg/day
Grazoprevir 100 mg/ day 12 weeks
• Elbasvir 50 mg/d
Elbasvir 50 mg/day 12 weeks
• Grazoprevir 100 mg/day
Grazoprevir 100 mg/day 16 weeks
• Elbasvir 50 mg/day
Elbasvir 50 mg/d 16 weeks
• Ribavirin 1200 mg/day
Ribavirin 1200 mg/day 16 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinic per a la Recerca Biomédica

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response	Sustained virological response 12 w (SVR24) defined as HCV-RNA undetectable at post-treatment week 12.	12 weeks post-treatment
Secondary	Sustained virological response	Sustained virological response 12 ( SVR12) defined as HCV-RNA undetectable at post-treatment weeks 4 and , 24 respectively.	4 weeks and 24 weeks post-treatment
Secondary	To evaluate the beneficial effects of antiviral therapy on renal function.	creatinine sample analyses blood analyses in all visits	24 weeks post-treatment
Secondary	To assess the impact of therapy in kidney function.	Elevation Transaminases blood analyses in all visits	24 weeks post-treatment
Secondary	Tolerability of this combination in liver transplant recipients.	Serious advers events evaluation	Every visit