NCT02897596

Brief Summary

Evaluate the efficacy of 12 or 8 weeks treatment with Grazoprevir/Elbasvir in Early Chronic Hepatitis C GT1,4 in HIV co-infected patients and evaluate the safety and tolerability of Grazoprevir + Elbasvir in HIV-HCV co-infected patients.

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
62

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2017

Typical duration for phase_3

Geographic Reach
1 country

1 active site

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

August 22, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

April 28, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

2 years

First QC Date

August 22, 2016

Last Update Submit

February 13, 2019

Conditions

Hepatitis CHIV

Outcome Measures

Primary Outcomes (1)

  • Sustained virological response.

    Sustained virological response 12 (SVR12) defined as HCV-RNA undetectable at post-treatment.

    24 weeks

Secondary Outcomes (3)

  • Reinfection rate

    1 year

  • Evaluate the safety and tolerability by means of number of participants with treatment-related adverse events.

    2 years

  • Evaluate the emergence of of viral resistance-associated variants (RAV) resistant to MK-5172 and MK-8742. during the follow up.

    2 years

Study Arms (2)

Genotype 1b

EXPERIMENTAL

Grazoprevir 100 mg/d during 8 weeks. Elbasvir 50 mg/d during 8 weeks.

Drug: Grazoprevir 100 mg/d 8 weeksDrug: Elbasvir 50 mg/d 8 weeks

Genotype 1a and 4

EXPERIMENTAL

Grazoprevir 100 mg/d during 12 weeks. Elbasvir 50 mg/d during 12 weeks.

Drug: Grazoprevir 100 mg/d 12 weeksDrug: Elbasvir 50 mg/d 12 weeks

Interventions

Grazoprevir 100 mg/d 8 weeksDRUG

Patients with 1b HCV genotype will be received treatment with Grazoprevir (100 mg) during 8 weeks.

Also known as: MK-5172 100 mg
Genotype 1b
Elbasvir 50 mg/d 8 weeksDRUG

Patients with 1b HCV genotype will be received treatment with Elbasvir (50mg) during 8 weeks.

Also known as: MK-8742 50 mg
Genotype 1b
Grazoprevir 100 mg/d 12 weeksDRUG

Patients with 1a or 4 HCV genotype will be received treatment with Grazoprevir (100 mg) during 12 weeks.

Also known as: MK-5172 100 mg
Genotype 1a and 4
Elbasvir 50 mg/d 12 weeksDRUG

Patients with 1a or 4 HCV genotype will be received treatment with Elbasvir (50mg) during 12 weeks.

Also known as: MK-8742 50 mg
Genotype 1a and 4

Eligibility Criteria

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

You may qualify if:

  • ≥18 years of age
  • Patients with early chronic hepatitis C (Genotype 1 or 4) which is defined as chronic hepatitis C with known episode of AHC within the last 4 years including those who failed to PEG/RBV or those who never received therapy for AHC. AHC infection is diagnosed on the basis of documented HCV-RNA positivity (\> 10.000 IU/mL) and anti-HCV seroconversion.
  • No history of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs/symptoms of advanced liver disease
  • Have liver disease staging assessment as follows: Fibroscan performed within 3 previous months of Day 1 of this study showing result \<8 kPa
  • Be HIV-1 infected, documented by any licensed rapid HIV test and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 antigen, or plasma HIV-1 RNA viral load.
  • Be on stable HIV Antiretroviral Therapy (ART) for at least 8 weeks prior to study entry using a dual NRTI backbone of tenofovir or abacavir

You may not qualify if:

  • \< 18 years of age
  • Patients with chronic hepatitis C genotypes other than 1 or 4.
  • History of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs/symptoms of advanced liver disease
  • Have liver disease staging assessment as follows: Fibroscan performed within 3 previous months of Day 1 of this study showing result \> 8kPa
  • Not be HIV-1 infected, documented by any licensed rapid HIV test and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 antigen, or plasma HIV-1 RNA viral load.
  • Due to known or suspected drug-drug interactions, for the purpose of this study, the use of Non Nucleoside Reverse Transcriptase Inhibitors, Inhibitors or Protease Inhibitors against HIV will be not allow.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico y provincial de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

grazoprevirelbasvir

Condition Hierarchy (Ancestors)

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

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
Project manager

Study Record Dates

First Submitted

August 22, 2016

First Posted

September 13, 2016

Study Start

April 28, 2017

Primary Completion

April 28, 2019

Study Completion

October 30, 2019

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

ES(1)