NCT02890719

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_3

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 22, 2025

Status Verified

June 1, 2025

Enrollment Period

10 months

First QC Date

August 24, 2016

Last Update Submit

June 17, 2025

Conditions

Liver TransplantationHepatitis C

Outcome Measures

Primary Outcomes (1)

  • Sustained virological response

    Sustained virological response 12 w (SVR24) defined as HCV-RNA undetectable at post-treatment week 12.

    12 weeks post-treatment

Secondary Outcomes (4)

  • Sustained virological response

    4 weeks and 24 weeks post-treatment

  • To evaluate the beneficial effects of antiviral therapy on renal function.

    24 weeks post-treatment

  • To assess the impact of therapy in kidney function.

    24 weeks post-treatment

  • Tolerability of this combination in liver transplant recipients.

    Every visit

Study Arms (2)

Genotype 1B

EXPERIMENTAL

treatment 12 weeks

Drug: Grazoprevir 100 mg/dayDrug: Elbasvir 50 mg/d

Genotype 1A and 4

EXPERIMENTAL

treatment 16 weeks

Drug: Grazoprevir 100 mg/dayDrug: Elbasvir 50 mg/dayDrug: Ribavirin 1200 mg/day

Interventions

Grazoprevir 100 mg/dayDRUG

Grazoprevir 100 mg/ day 12 weeks

Also known as: J05AX68 100 mg
Genotype 1B
Elbasvir 50 mg/dDRUG

Elbasvir 50 mg/day 12 weeks

Also known as: J05AX68 50mg
Genotype 1B
Elbasvir 50 mg/dayDRUG

Elbasvir 50 mg/d 16 weeks

Also known as: 50mg J05AX68
Genotype 1A and 4
Ribavirin 1200 mg/dayDRUG

Ribavirin 1200 mg/day 16 weeks

Also known as: J05AB04 1200 mg/d
Genotype 1A and 4

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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):
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C

Interventions

grazoprevirelbasvirRibavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Xavier Forns

Study Record Dates

First Submitted

August 24, 2016

First Posted

September 7, 2016

Study Start

August 3, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

June 22, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share