Pilot Study Evaluate Efficacy of Grazoprevir + Elbasvir for 12 or 16 Weeks in Liver Transplant Recipients.
NCT ID: NCT02890719
Last Updated: 2025-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2016-08-03
2017-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Genotype 1B
treatment 12 weeks
Grazoprevir 100 mg/day
Grazoprevir 100 mg/ day 12 weeks
Elbasvir 50 mg/d
Elbasvir 50 mg/day 12 weeks
Genotype 1A and 4
treatment 16 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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
78 Years
ALL
No
Sponsors
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Fundacion Clinic per a la Recerca Biomédica
OTHER
Responsible Party
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Anna Cruceta
Xavier Forns
Other Identifiers
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2015-005453-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EGRADICATE
Identifier Type: -
Identifier Source: org_study_id
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