NCT03037151

Brief Summary

This study will evaluate the safety and efficacy of combination treatment with grazoprevir + elbasvir for compensated cirrhotic participants with chronic genotype 1 (GT1) and genotype 6 (GT6) hepatitis C virus (HCV) infection with or without human immunodeficiency virus (HIV) infection.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2018

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

January 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
1.5 years until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

2.4 years

First QC Date

January 27, 2017

Last Update Submit

February 11, 2020

Conditions

Compensated Cirrhosis

Keywords

SafetyEfficacygrazoprevirelbasvircompensated cirrhosisgenotype 1 (GT1)genotype 6 (GT6)hepatitis virus C (HCV)human immunodeficiency virus (HIV)

Outcome Measures

Primary Outcomes (1)

  • Rate of SVR12

    To evaluate the rate of sustained virological response (SVR) at 12 weeks after the end of treatment (SVR12) in compensated cirrhotic participants with GT1 and GT6 HCV infection with or without HIV infection treated with the combination of grazoprevir and elbasvir

    12 weeks post-treatment

Secondary Outcomes (3)

  • Rate of SVR24

    24 weeks post-treatment

  • Decline of liver stiffness

    5 years post-treatment

  • changes in liver stiffness

    5 years

Study Arms (4)

HCV mono-infection Treatment naives

EXPERIMENTAL

HCV treatment-naïve patients will be treated with the combination of grazoprevir plus elbasvir for 12 weeks.

Drug: Grazaoprevir/Elbasavir

HCV mono-infection Treatment experienced

EXPERIMENTAL

HCV treatment-experienced patients, including null responders, partial responders or post-treatment relapsers, will be assigned to treat with the combination plus weight-based RBV for 16 weeks.

Drug: Grazaoprevir/Elbasavir/RBV

HCV/HIV co-infection Treatment naives

EXPERIMENTAL

HCV/HIV coinfected, treatment-naïve patients will be treated with the combination of grazoprevir plus elbasvir for 12 weeks.

Drug: Grazaoprevir/Elbasavir

HCV/HIV co-infection Treatment experienced

EXPERIMENTAL

HCV/HIV co-infected treatment-experienced patients, including null responders, partial responders or post-treatment relapsers, will be assigned to treat with the combination plus weight-based RBV for 16 weeks.

Drug: Grazaoprevir/Elbasavir/RBV

Interventions

Grazaoprevir/ElbasavirDRUG

treatment naive

HCV mono-infection Treatment naivesHCV/HIV co-infection Treatment naives
Grazaoprevir/Elbasavir/RBVDRUG

treatment experienced

HCV mono-infection Treatment experiencedHCV/HIV co-infection Treatment experienced

Eligibility Criteria

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

You may qualify if:

  • Men and women aged 18 years or older
  • Documented chronic HCV GT1 or GT6 (positive for anti-HCV antibody and HCV RNA at least 6 months prior to screening)
  • HCV RNA of at least 10,000 IU/ml
  • Cirrhosis defined by: liver biopsy showing cirrhosis METAVIR F4; or TE showing cirrhosis with a result of \>13.0 kPa
  • Treatment-naïve individuals for chronic HCV infection
  • Treatment-experienced individuals (Previous treatment failure with PEG-IFN plus RBV) for chronic HCV infection
  • HIV-infected participants enrolled in this study must meet following criteria:
  • Documented HIV infection 7.2 Naïve to treatment with any antiretroviral therapy (ART) or on HIV ART for at least 8 weeks prior to study entry using a dual nucleoside reverse transcriptase inhibitor (NRTI) backbone of tenofovir or abacavir and either emtricitabine or lamivudine plus raltegravir (or dolutegravir or rilpivirine) 7.3 CD4+ T-cell count \>200 cells/mm3 if on ART or \>500 cell/mm3 if ART treatment naïve 7.4 Undetectable plasma HIV-RNA at least 8 weeks prior to screening if on ART or \<50,000 copies/mL if ART treatment naïve
  • Agree to use two acceptable methods of birth control from at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations (for female subject who is of childbearing potential or male subject with female sexual partner who is of childbearing potential).

You may not qualify if:

  • Evidence of decompensated liver disease (Child-Pugh Class B or C or Child-Pugh score \>6, platelets less than 75 × 10³/μL, serum albumin \< 3·0 g/dL, presence of or history of ascites, gastric or variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease)
  • Co-infected with hepatitis B virus
  • Has cirrhosis and liver imaging within 6 months showing evidence of HCC or is under evaluation for HCC
  • Pregnant or breast-feeding from day 1 or anytime during treatment, and 14 days after the last dose of study medication
  • Any medical condition requiring or likely to require chronic systemic administration of corticosteroids or other immunosuppressant drugs during the course of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Location

HIV-NAT, Thai Red Cross AIDS Research Centre

Bangkok, 10330, Thailand

Location

Related Links

MeSH Terms

Conditions

Hepatitis CAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHIV InfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Anchalee Avihingsanon, MD, PhD

    HIV-NAT, Thai Red Cross - AIDS Research Centre

    PRINCIPAL INVESTIGATOR

  • Pisit Tangkijvanich, MD

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2017

First Posted

January 31, 2017

Study Start

August 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 13, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

only when needed as per the auditing/monitoring processes and requirement

Locations

TH(2)