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

November 2, 2017 updated by: Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Genotype 1B
treatment 12 weeks
Drug: Grazoprevir 100 mg/day
Grazoprevir 100 mg/ day 12 weeks
Other Names:
  • J05AX68 100 mg
Drug: Elbasvir 50 mg/d
Elbasvir 50 mg/day 12 weeks
Other Names:
  • J05AX68 50mg
Drug: Grazoprevir 100 mg/day
Grazoprevir 100 mg/day 16 weeks
Other Names:
  • J05AX68 100 mg
Experimental: Genotype 1A and 4
treatment 16 weeks
Drug: Grazoprevir 100 mg/day
Grazoprevir 100 mg/ day 12 weeks
Other Names:
  • J05AX68 100 mg
Drug: Grazoprevir 100 mg/day
Grazoprevir 100 mg/day 16 weeks
Other Names:
  • J05AX68 100 mg
Drug: Elbasvir 50 mg/day
Elbasvir 50 mg/d 16 weeks
Other Names:
  • 50mg J05AX68
Drug: Ribavirin 1200 mg/day
Ribavirin 1200 mg/day 16 weeks
Other Names:
  • J05AB04 1200 mg/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained virological response
Time Frame: 12 weeks post-treatment
Sustained virological response 12 w (SVR24) defined as HCV-RNA undetectable at post-treatment week 12.
12 weeks post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained virological response
Time Frame: 4 weeks and 24 weeks post-treatment
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
To evaluate the beneficial effects of antiviral therapy on renal function.
Time Frame: 24 weeks post-treatment
creatinine sample analyses blood analyses in all visits
24 weeks post-treatment
To assess the impact of therapy in kidney function.
Time Frame: 24 weeks post-treatment
Elevation Transaminases blood analyses in all visits
24 weeks post-treatment
Tolerability of this combination in liver transplant recipients.
Time Frame: Every visit
Serious advers events evaluation
Every visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Clinic per a la Recerca Biomédica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2017

Primary Completion (Actual)

June 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

August 24, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 2, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGRADICATE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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