Clinical Trials

MainTitle

Safety and Efficacy of Grazoprevir and Elbasvir for GT1ang GT6 With and Without HIV

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified August 2017 by The HIV Netherlands Australia Thailand Research Collaboration

Sponsor
The HIV Netherlands Australia Thailand Research Collaboration

Collaborator
Chulalongkorn University
Merck Sharp & Dohme Corp.

Information provided by (Responsible Party)
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier
NCT03037151

First received: January 27, 2017
Last updated: August 9, 2017
Last Verified: August 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Compensated Cirrhosis

Drug : Grazaoprevir/Elbasavir
Drug : Grazaoprevir/Elbasavir/RBV
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Fibrosis Improvement of Grazoprevir and Elbasvir for HCV GT1 and GT6 With or Without HIV

Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures

  • Rate of SVR12 [ Time Frame: 12 weeks post-treatment ]
    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
Secondary Outcome Measures:
  • Rate of SVR24 [ Time Frame: 24 weeks post-treatment ]
    To evaluate the rate of sustained virological response (SVR) at 24 weeks after the end of treatment (SVR24)
  • Decline of liver stiffness [ Time Frame: 5 years post-treatment ]
    To evaluate the percentage of participants achieving a significant decline in liver stiffness (LS) values (defined as a ≥30% decrease from baseline) up to 240 weeks (5 years) after treatment
  • changes in liver stiffness [ Time Frame: 5 years ]
    To compare the longitudinal changes in LS values over time between participants and untreated historical controls

Estimated Enrollment: 100
Study Start Date: November 1, 2017
Estimated Study Completion Date: January 19, 2022
Estimated Primary Completion Date: January 19, 2022 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: HCV mono-infection Treatment naives
HCV treatment-naïve patients will be treated with the combination of grazoprevir plus elbasvir for 12 weeks.
Drug: Grazaoprevir/Elbasavir

treatment naive

Experimental: HCV mono-infection Treatment experienced
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

treatment experienced

Experimental: HCV/HIV co-infection Treatment naives
HCV/HIV coinfected, treatment-naïve patients will be treated with the combination of grazoprevir plus elbasvir for 12 weeks.
Drug: Grazaoprevir/Elbasavir

treatment naive

Experimental: HCV/HIV co-infection Treatment experienced
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

treatment experienced

Detailed Description:

Total 100 patients with compensated cirrhosis, chronically infected with HCV GT1 or GT6 with or without HIV infection will be included. Patients with HCV GT1 and GT6 will be enrolled on a 1:1 basis (approximately 50 patients with GT1 and 50 patients with GT6). Treatment-naïve patients will be treated with the combination of grazoprevir plus elbasvir for 12 weeks. 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. The dosages of study drugs are 100 mg of grazoprevir once daily and 50 mg of elbasvir once daily. All patients will follow up to assess SVR (defined by HCV RNA level <12 IU/mL) at week12 and week 24 after treatment (SVR12 and SVR24, respectively). Additionally, participants will be evaluated the longitudinal changes in LS values by TE up to 240 weeks (5 years) after treatment

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

    1. Men and women aged 18 years or older
    2. Documented chronic HCV GT1 or GT6 (positive for anti-HCV antibody and HCV RNA at least 6 months prior to screening)
    3. HCV RNA of at least 10,000 IU/ml
    4. Cirrhosis defined by: liver biopsy showing cirrhosis METAVIR F4; or TE showing cirrhosis with a result of >13.0 kPa
    5. Treatment-naïve individuals for chronic HCV infection
    6. Treatment-experienced individuals (Previous treatment failure with PEG-IFN plus RBV) for chronic HCV infection
    7. HIV-infected participants enrolled in this study must meet following criteria:
      1. 1 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
    8. 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).


Exclusion Criteria:
    1. 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)
    2. Co-infected with hepatitis B virus
    3. Has cirrhosis and liver imaging within 6 months showing evidence of HCC or is under evaluation for HCC
    4. Pregnant or breast-feeding from day 1 or anytime during treatment, and 14 days after the last dose of study medication
    5. Any medical condition requiring or likely to require chronic systemic administration
    of corticosteroids or other immunosuppressant drugs during the course of the study

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03037151

Contacts

Contact:   June Ohata, BS 662 652 3040 ext 147 juneohata4@gmail.com

Locations

Thailand
Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand, 10330
HIV-NAT, Thai Red Cross AIDS Research Centre Not yet recruiting
Bangkok, Thailand, 10330
Contact: Anchalee Avihingsanon, MD, PhD    662 652 3040    anchaleea2009@gmail.com

Sponsors and Collaborators

The HIV Netherlands Australia Thailand Research Collaboration
Chulalongkorn University
Merck Sharp & Dohme Corp.

Investigators

Principal Investigator: Anchalee Avihingsanon, MD, PhD HIV-NAT, Thai Red Cross - AIDS Research Centre
Principal Investigator: Pisit Tangkijvanich, MD Chulalongkorn University
More Information

More Information

Additional Information:

Related Info

Responsible Party: The HIV Netherlands Australia Thailand Research Collaboration  
ClinicalTrials.gov Identifier: NCT03037151   History of Changes  
Other Study ID Numbers: HIV-NAT 245  
Study First Received: January 27, 2017  
Last Updated: August 9, 2017  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:

Safety
Efficacy
grazoprevir
elbasvir
compensated cirrhosis
genotype 1 (GT1)
genotype 6 (GT6)
hepatitis virus C (HCV)
human immunodeficiency virus (HIV)

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.