Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing Care Linkage in People Who Inject Drugs

  • STATUS
    Recruiting
  • End date
    Feb 12, 2022
  • participants needed
    60
  • sponsor
    Kirby Institute
Updated on 1 March 2021

Summary

This study will evaluate the proportion of patients achieving confirmed SVR12 (undetectable HCV RNA at time point 12 weeks plus post treatment commencement) in patients hospitalised for IRID (injecting related infectious diseases) and commencing inpatient DAA treatment within public hospital services.

Description

This study will be conducted as a Phase IV, multicentre, sequential cohort trial.

60 participants will be enrolled from participating hospital inpatient services. They will be evaluated for eligibility by the use of rapid point-of-care (POC) confirmation of viraemia in people who inject drugs (PWID) hospitalised for IRID. The period of hospitalisation for management of IRID, particularly when prolonged, may represent an ideal opportunity to engage HCV-infected PWID and a potential important strategy for broader HCV elimination.

Eligible patients will be enrolled into one of two treatment cohorts A and B.

  1. 30 patients will immediately commence treatment whilst an inpatient of G/P (glecaprevir/pibrentasvir) with continuation of therapy and follow-up in viral hepatitis services post discharge (standard duration therapy).

Following the successful completion of Cohort A, eligible patients will be enrolled into Cohort B.

B) 30 patients will immediately commence treatment whilst an inpatient of 4 weeks of SOF/G/P (sofosbuvir/glecaprevir/pibrentasvir) with continuation of therapy and follow-up in viral hepatitis services post discharge (short duration therapy).

Any patient with recurrent viraemia during follow-up will be genotyped +/- sequenced to exclude re-infection. If relapse is confirmed the patient will be offered re-treatment with standard of care (SOC) salvage therapy based on results of resistance testing.

Details
Condition Cirrhosis, LIVER DISEASE, Hepatitis, Hepatitis C, Hepatitis C virus, Hepatic Fibrosis, Liver Disorders
Treatment Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet, Sofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
Clinical Study IdentifierNCT03981211
SponsorKirby Institute
Last Modified on1 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Hepatitis C virus or LIVER DISEASE or Liver Disorders or Hepatitis or Hepatitis C or Hepatic Fibrosis or Cirrhosis?
Do you have any of these conditions: Hepatitis C virus or Hepatic Fibrosis or Liver Disorders or LIVER DISEASE or Hepatitis C or Cirrhosis or Hepatitis?
Participants must meet all of the following inclusion criteria to be eligible
to participate in this study
Have voluntarily signed the informed consent form
18 years of age or older
Injected drugs within the last 6 months
Hospitalised with an IRID with an anticipated inpatient stay of > 1 week
Participants must meet the following additional inclusion criteria to be
treated in this study
\. HCV RNA positive
\. Compensated liver disease
\. Documented non-cirrhotic at enrolment with a qualifying liver FibroScan
5 kpA
\. If co-infection with HIV is documented, the subject must meet the
following criteria
ART nave with CD4 T cell count >500 cells/mm3; OR
On a stable ART regimen (containing only permissible ART) for >4 weeks prior to screening visit, with CD4 T cell count 200 cells/mm3 and a plasma HIV RNA level below the limit of detection

Exclusion Criteria

Participants who meet any of the exclusion criteria are not to be enrolled in
this study
Inability or unwillingness to provide informed consent or abide by the requirements of the study
Actively intoxicated
Participants that meet any of the additional exclusion criteria are not to be
treated in this study
\. History of any of the following
b. Clinical hepatic compensation (i.e. ascites, encephalopathy or variceal
haemorrhage) c. Solid organ transplant d. History of severe, life-threatening
or other significant sensitivity to study drugs
(glecaprevir/pibrentasvir/sofosbuvir) or any excipients of the study drugs
\. Creatinine clearance (CLcr) < 30 mL/min at screening (Cohort B only)
\. Pregnant or nursing female
\. Decompensated liver disease
\. Use of prohibited concomitant medications
\. Chronic use of systemically administered immunosuppressive agents (e.g
prednisone equivalent > 10 mg/day for >2 weeks)
\. Prior treatment failure with an NS5A based DAA regimen
Patients without an IRID but who fulfill all other criteria and are admitted
with an expected duration of stay > 1 week may also be included at discretion
of study team
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note