AzTrials
AzTrials

Chronic Hepatitis cPhase 4NCT03723824

Grazoprevir/Elbasvir for Genotype 1b Chronic Hepatitis C After Liver or Kidney Transplantation

A Phase 4 study testing grazoprevir 100 mg/ elbasvir 50 mg, Zepatier® in people with Chronic Hepatitis c and Liver Transplant Infection, run by Taichung Veterans General Hospital at 2 sites in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Grazoprevir/elbasvir combination therapy is highly effective in the treatment of genotype 1b chronic hepatitis C, and the drug-drug interaction with central immunosuppressant, such as tacrolimus, should be manageable. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
grazoprevir 100 mg/ elbasvir 50 mg, Zepatier®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
2 sitesTaiwan
Study dates
14 Feb 2019to 13 Mar 2021
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 20 years of age
  • Chronically infected with genotypes 1b HCV
  • Underwent liver and/ or kidney transplantation
  • Without clinical or pathologic evidence of moderate or severe rejection

Who cannot join

  • HCV genotype other than 1b
  • Liver decompensation (Child-Pugh score > 6)
  • Co-infected with human immunodeficiency virus: Positive HIV1/2 or hepatitis B virus : Positive HBsAg and detected HBV DNA
  • Prior exposure to an NS5A inhibitor
  • Any active malignancies
  • Hemoglobin level less than 10 g/dl
Show all 14Show fewer
  • Platelet level of 75,000/mm3 or less
  • Alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase level 10 times or more the upper limit of normal
  • Total bilirubin level greater than 3 times or more the upper limit of normal
  • Albumin less than 3 g/dL
  • Using medication that is not considered safe to co-administer with , such as cyclosporine
  • Pregnant or breast-feeding women
  • Known allergy to grazoprevir or elbasvir
  • (Unregistered liver or kidney transplant in other countries is illegal in Taiwan)

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

  • Taichung Veterans General Hospital

    Taichung, 40705

  • China Medical University Hospital

    Taichung

Other trials in Taiwan

About this study

Official title: An Open-label, Cohort Study of Grazoprevir/Elbasvir Combination Therapy for Patients With Genotype 1b Chronic Hepatitis C After Liver or Kidney Transplantation

Grazoprevir/elbasvir combination therapy is highly effective in the treatment of genotype 1b chronic hepatitis C, and the drug-drug interaction with central immunosuppressant, such as tacrolimus, should be manageable. The aim of this study is to assess the efficacy and tolerability of grazoprevir/elbasvir combination therapy in treating genotype 1b chronic hepatitis C after liver or kidney transplantation.

Read the detailed description

Grazoprevir/elbasvir combination therapy (grazoprevir 100 mg/ elbasvir 50 mg, Zepatier®, MSD) has been recommended as the 1st-line treatment for genotype 1b chronic hepatitis C by the updated international guidelines, and the rates of sustained virologic response (SVR) can be higher than 95% in either treatment-naïve or peginterferon-experienced patients with genotype 1b chronic hepatitis C. Moreover, even among patients with liver cirrhosis, the efficacy of grazoprevir/elbasvir combination therapy remains very high. In addition, drug-related adverse effects (AEs) were quite low in previous studies, and less than 1% of cirrhotic patients discontinued this therapy during treatment period (4). Grazoprevir/elbasvir combination therapy is an effective and safe treatment for chronic hepatitis C.

Chronic hepatitis C is one of the most common indications for liver transplantation. Patients underwent liver or kidney transplantation always suffer from recurrent chronic hepatitis C. Recurrent chronic hepatitis C can result in liver cirrhosis, liver decompensation, and death. Chronic hepatitis C is also associated with a higher incidence of chronic rejection, graft failure and mortality after kidney transplantation. Treating hepatitis C virus (HCV) infection after liver or kidney transplantation was a big challenge before the development of new direct-acting antiviral (DAA). Not only a low SVR rate but also a high rate of severe adverse effects results in the hesitation of peginterferon-ribavirin combination therapy. Although some new DAAs can be used in organ transplantation, the cost remains quite high. More new DAA choices for patients underwent organ transplantation are needed.

The clinical data of grazoprevir/elbasvir combination therapy on the treatment for patients with chronic hepatitis C after liver or kidney transplantation remain lacking. With high virologic response rates and low adverse effects in the management for chronic hepatitis C, grazoprevir/elbasvir combination therapy could be a good option for patients underwent liver or kidney transplantation. No drug-drug interaction (DDI) was noted between grazoprevir/elbasvir combination therapy and steroid, and the DDI with the most commonly-used immunosuppressant, tacrolimus, was also not significant, The drug levels of immunosuppressants can be carefully monitored and adjusted during treatment period. The aim of this study is to assess the efficacy and tolerability of grazoprevir/elbasvir combination therapy in treating genotype 1b chronic hepatitis C after liver or kidney transplantation.

Being tested
grazoprevir 100 mg/ elbasvir 50 mg, Zepatier®
Medical subject headings
Hepatitis C, Chronic

What participants receive

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

  • grazoprevir 100 mg/ elbasvir 50 mg, Zepatier®Drug

    Also called Zepatier

    grazoprevir 100 mg/ elbasvir 50 mg (Zepatier®, MSD) once daily for 12 weeks

Study groups in NCT03723824
Study groupRoleWhat they receive
Zepatier therapyExperimentalgrazoprevir 100 mg/ elbasvir 50 mg (Zepatier®, MSD) once daily for 12 weeks
Receives: Drug: grazoprevir 100 mg/ elbasvir 50 mg, Zepatier®

What is being measured

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

  1. Sustained virologic response (SVR)

    The HCV viral load (IU/mL) in blood at post-treatment week 12 (SVR12)

    Measured: At post-treatment week 12

Secondary outcomes (2)

  1. Adverse effects (AEs)

    Any AEs during the treatment period

    Measured: During the treatment period (the 1st, 2nd, 4th, 6th, 8th, 10th, 12th weeks)

  2. Used immunosuppressant blood levels

    The immunosuppressant concentration (ng/mL) in blood during the treatment period

    Measured: During the treatment period (the 1st, 2nd, 4th, 6th, 8th, 10th, 12th weeks)

Timeline

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

  1. First posted30 Oct 2018
  2. Study start14 Feb 2019
  3. Primary completion30 Nov 2020
  4. Study completion13 Mar 2021

Why it stopped: COV-19 pandemic

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
Not applicable
Intervention model
Single group
Model description
grazoprevir 100 mg/ elbasvir 50 mg, Zepatier®, 1# qd for 12 weeks
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03723824
Sponsor's protocol ID
SF18281A
Status last verified
Mar 2021
First submitted
26 Oct 2018
Last updated
16 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zeuzem S, Ghalib R, Reddy KR, Pockros PJ, Ben Ari Z, Zhao Y, Brown DD, Wan S, DiNubile MJ, Nguyen BY, Robertson MN, Wahl J, Barr E, Butterton JR. Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial. Ann Intern Med. 2015 Jul 7;163(1):1-13. doi: 10.7326/M15-0785.

    PubMed 25909356

  • Kwo P, Gane EJ, Peng CY, Pearlman B, Vierling JM, Serfaty L, Buti M, Shafran S, Stryszak P, Lin L, Gress J, Black S, Dutko FJ, Robertson M, Wahl J, Lupinacci L, Barr E, Haber B. Effectiveness of Elbasvir and Grazoprevir Combination, With or Without Ribavirin, for Treatment-Experienced Patients With Chronic Hepatitis C Infection. Gastroenterology. 2017 Jan;152(1):164-175.e4. doi: 10.1053/j.gastro.2016.09.045. Epub 2016 Oct 5.

    PubMed 27720838

  • Jacobson IM, Lawitz E, Kwo PY, Hezode C, Peng CY, Howe AYM, Hwang P, Wahl J, Robertson M, Barr E, Haber BA. Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis. Gastroenterology. 2017 May;152(6):1372-1382.e2. doi: 10.1053/j.gastro.2017.01.050. Epub 2017 Feb 11.

    PubMed 28193518

  • Lai PC, Chen CH, Jeng LB, Yu TM, Tsai SF, Wu MJ, Cheng SB, Yang SS, Lee TY. Grazoprevir/Elbasvir Treatment in Liver or Kidney Transplant Recipients with Genotype 1b Hepatitis C Virus Infection. Antimicrob Agents Chemother. 2022 Feb 15;66(2):e0200321. doi: 10.1128/AAC.02003-21. Epub 2021 Dec 13.

    PubMed 34902265

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing grazoprevir 100 mg/ elbasvir 50 mg, Zepatier® in people with Chronic Hepatitis c and Liver Transplant Infection, run by Taichung Veterans General Hospital at 2 sites in Taiwan.

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 4 inclusion and 14 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: stopped early, as of the sponsor's last update on 16 Mar 2021. 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 Taiwan. 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?

The study was stopped early (reason given: COV-19 pandemic). 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?

Sustained virologic response (SVR) (time frame: At post-treatment week 12). 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 NCT03723824, which also lists 4 linked publications.

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 16 Mar 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in