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Compensated CirrhosisPhase 4NCT03037151

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

A Phase 4 study testing Grazaoprevir/Elbasavir and Grazaoprevir/Elbasavir/RBV in people with Compensated Cirrhosis, run by The HIV Netherlands Australia Thailand Research Collaboration at 2 sites in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Compensated Cirrhosis
What is being tested?
Grazaoprevir/Elbasavir and Grazaoprevir/Elbasavir/RBV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesThailand
Study dates
1 Aug 2018to 31 Dec 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • HIV-infected participants enrolled in this study must meet following criteria:
  • 7.1 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
  • 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).

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Thailand2 sites

  • Faculty of Medicine, Chulalongkorn University

    Bangkok, 10330

  • HIV-NAT, Thai Red Cross AIDS Research Centre

    Bangkok, 10330

Other trials in Thailand

About this study

Official title: Safety and Fibrosis Improvement of Grazoprevir and Elbasvir for HCV GT1 and GT6 With or Without HIV

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.

Read the 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

Being tested
Grazaoprevir/Elbasavir, Grazaoprevir/Elbasavir/RBV
Keywords
Safety, Efficacy, grazoprevir, elbasvir, compensated cirrhosis, genotype 1 (GT1), genotype 6 (GT6), hepatitis virus C (HCV), human immunodeficiency virus (HIV)
Medical subject headings
Hepatitis C, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Grazaoprevir/ElbasavirDrug

    treatment naive

  • Grazaoprevir/Elbasavir/RBVDrug

    treatment experienced

Study groups in NCT03037151
Study groupRoleWhat they receive
HCV mono-infection Treatment naivesExperimentalHCV treatment-naïve patients will be treated with the combination of grazoprevir plus elbasvir for 12 weeks.
Receives: Drug: Grazaoprevir/Elbasavir
HCV mono-infection Treatment experiencedExperimentalHCV 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.
Receives: Drug: Grazaoprevir/Elbasavir/RBV
HCV/HIV co-infection Treatment naivesExperimentalHCV/HIV coinfected, treatment-naïve patients will be treated with the combination of grazoprevir plus elbasvir for 12 weeks.
Receives: Drug: Grazaoprevir/Elbasavir
HCV/HIV co-infection Treatment experiencedExperimentalHCV/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.
Receives: Drug: Grazaoprevir/Elbasavir/RBV

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 weeks post-treatment

Secondary outcomes (3)

  1. Rate of SVR24

    To evaluate the rate of sustained virological response (SVR) at 24 weeks after the end of treatment (SVR24)

    Measured: 24 weeks post-treatment

  2. Decline of liver stiffness

    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

    Measured: 5 years post-treatment

  3. changes in liver stiffness

    To compare the longitudinal changes in LS values over time between participants and untreated historical controls

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2017 (estimated)
  2. Study start1 Aug 2018
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03037151
Sponsor's protocol ID
HIV-NAT 245
Status last verified
Feb 2020
First submitted
27 Jan 2017
Last updated
13 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: only when needed as per the auditing/monitoring processes and requirement

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Grazaoprevir/Elbasavir and Grazaoprevir/Elbasavir/RBV in people with Compensated Cirrhosis, run by The HIV Netherlands Australia Thailand Research Collaboration at 2 sites in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of SVR12 (time frame: 12 weeks post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03037151.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.

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