Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/P

  • STATUS
    Recruiting
  • End date
    Dec 2, 2024
  • participants needed
    90
  • sponsor
    Kirby Institute
Updated on 2 July 2021

Summary

An open label, multicentre, international pilot study of paritaprevir/ritonavir, ombitasvir, dasabuvir with or without ribavirin or glecaprevir/pibrentasvir for people with recently acquired hepatitis C virus infection with or without HIV co-infection.

Description

The use of a highly potent IFN-sparing drug combination in the setting of recently acquired 1 HCV infection is hypothesised to result in the vast majority of patients achieving SVR. In this setting, it is anticipated that therapy can be shortened relative to that used in established chronic infection. A short course IFN-free strategy is likely to be highly attractive to both patients and clinicians and if proven may further encourage early HCV testing and diagnosis.

In this pilot study, the investigators plan to explore the safety, efficacy and feasibility of the IFN-sparing combination for treatment of recently acquired HCV infection.

Cohort One: paritaprevir/ritonavir/ombitasvir, dasabuvir with/without ribavirin (HCV genotype 1 only) Cohort Two (and Three): glecaprevir/pibrentasvir (HCV genotypes 1-6)

Details
Condition Hepatitis C, Acute, Hepatitis C, Acute, Hepatitis C, Acute, Hepatitis C, Acute, Hepatitis C, Acute, Hepatitis C, Acute, Hepatitis C, Acute, Hepatitis C, Acute, Hepatitis C, Acute
Treatment Ribavirin, dasabuvir, Glecaprevir/Pibrentasvir, Paritaprevir/ritonavir/ombitasvir
Clinical Study IdentifierNCT02634008
SponsorKirby Institute
Last Modified on2 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Provision of written informed consent
Male and female patients aged 18 years and over
For Cohort One: willing to use two effective methods of contraception during the treatment period and 24 weeks post
For Cohort Two and Three: If female and of childbearing potential, willing to use at least one effective method of contraception during the treatment period and 4 weeks post; women not of childbearing potential include those who are postmenopausal or permanently surgically sterile (no contraception is required for male participants)
For Cohort One, Two and Three: Females of child-bearing potential must have a negative pregnancy test at screening and immediately prior to first dose of study drugs
HCV genotype 1 infection at screening (Cohort 1 only)
Detectable HCV RNA at screening (>10,000 IU/ml), and in the opinion of the investigator is unlikely to demonstrate spontaneous viral clearance
Absence of cirrhosis, as defined by one of the following
Liver biopsy within 24 months prior to or during screening demonstrating absence of cirrhosis (eg, METAVIR fibrosis score 3, Ishak fibrosis score 4); or
FibroScan score < 12.5 kPa within 6 months of screening or during screening period; or
Medically stable on the basis of physical examination, medical history and vital signs
Adequate English to provide reliable responses to the study questionnaires
Recently acquired HCV infection (estimated duration of infection 12 months) as defined by
i) First anti-HCV Ab or HCV RNA positive within the previous 6 months and ii) Documented anti-HCV Ab negative within the 18 months prior to anti-HCV antibody positive result
OR
\. i) First anti-HCV Ab or HCV RNA positive within the previous 6 months and
ii) Acute clinical hepatitis (jaundice or ALT> 10 X ULN) within the previous
months prior to first positive HCV antibody or HCV RNA, with no other cause
of acute hepatitis identifiable
OR
\. i) First anti-HCV Ab or HCV RNA positive within the previous 6 months and
ii) Acute asymptomatic hepatitis (acute rise in ALT> 5 X ULN) within the
previous 12 months prior to first positive HCV antibody or HCV RNA and
documented normal ALT within the previous 12 months with no othercause of
acute hepatitis identifiable (In individuals with a previously high ALT, an
acute rise to >3.5 x their previous peak ALT in last 12 months is acceptable)
OR
\. For cases of recent HCV reinfection the following criteria are required
Documented prior HCV antibody positive with HCV RNA negative on at least 2
occasions 6 months apart AND new HCV RNA positive within the previous 6
months
Estimated duration of infection based on midpoint between last antibody or RNA negative and first antibody or HCV RNA positive in the case of seroconversion and 6 weeks prior to date of maximum ALT in the case of acute hepatitis
If co-infection with HIV is documented, the subject must meet the following
criteria
Cohort One
On a stable qualifying ARV regimen for >8 weeks prior to screening visit, with CD4 T cell count >200 cells/mm3 and a plasma HIV RNA below the limit of detection
Cohort Two
On a stable qualifying ARV regimen for >8 weeks prior to screening visit, with
CD4 T cell count >200 cells/mm3 and a plasma HIV RNA below the limit of
detection
OR
ARV nave with CD4 T cell count >500 cells/mm3

Exclusion Criteria

Pregnancy/lactation
Infection or co-infection with an HCV genotype other than 1 (Cohort 1 only)
Subject has current or past clinical evidence of decompensated liver disease, such as ascites, hepatic encephalopathy, oesophageal varices, and/or any of the following screening laboratory results
International Normalized Ration (INR) > 1.5
Patients with a known inherited blood disorder and INR > 1.5 may be enrolled after discussion with the Principal Investigator
Serum albumin <3.3 g/dL
Serum total bilirubin >1.8 x upper limit of normal (ULN), unless isolated in subjects with Gilbert's syndrome
Subject shows evidence of significant liver disease in addition to hepatitis C, which may include but is not limited to drug- or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, non-alcoholic steatohepatitis (NASH), or primary biliary cirrhosis
Subject has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma)
History of chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
Poorly controlled diabetes mellitus as evidenced by haemoglobin A1c (HbA1c) 8.5%
Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug
Prior treatment failure with an HCV protease inhibitor
Any investigational drug 6 weeks prior to the first dose of study drug
Positive test at screening for anti-HAV IgM Ab, anti-HBc IgM Ab or HBsAg
Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to screening or on an ultrasound performed at screening (a positive ultrasound result will be confirmed with CT scan or MRI)
Subject has history of organ transplant that requires chronic immunosuppression
Corneal, skin, and hair grafts are allowed
History of severe psychiatric disease that in the opinion of the investigator is unstable enough to compromise treatment adherence
Subject has evidence of serious or severe bacterial or fungal infection(s), including active tuberculosis
Prohibited medications and herbal remedies as detailed in section 5.5
Screening laboratory tests showing any of the following abnormal results
Haemoglobin <100 g/L
Calculated creatinine clearance <50mL/min
Platelets <100,000 cells/mm3
Absolute neutrophil count (ANC) <1,500 cells/L
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

0/250
Preferred Language
Other Language
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