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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02634008




Registration number
NCT02634008
Ethics application status
Date submitted
9/12/2015
Date registered
17/12/2015

Titles & IDs
Public title
Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/P
Scientific title
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.
Secondary ID [1] 0 0
VHCRP1502
Universal Trial Number (UTN)
Trial acronym
TARGET3D
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Acute 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Cohort 1 - Paritaprevir/ritonavir/ombitasvir (75mg/50mg/12.5mg) and dasabuvir (250mg) with or without ribavirin (1000-1200mg) daily taken orally for 8 weeks.

Experimental: Cohort 2 - Three tablets of glecaprevir/pibrentasvir (100mg/40mg) daily taken orally for 6 weeks

Experimental: Cohort 3 - Three tablets of glecaprevir/pibrentasvir (100mg/40mg) daily taken orally for 4 weeks
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of treated subjects (intention-to-treat (ITT) population) demonstrating undetectable hepatitis C virus (HCV) RNA at 12 weeks following treatment (SVR 12).
Timepoint [1] 0 0
12 weeks post treatment
Secondary outcome [1] 0 0
The proportion of treated subjects overall with ETR, SVR4 and SVR24 defined as undetectable HCV RNA at end of therapy, 4 weeks and 24 weeks post therapy, respectively.
Timepoint [1] 0 0
End of treatment- week 6 or week 8 depending on the study arm; 4 weeks post treatment; 24 weeks post treatment
Secondary outcome [2] 0 0
Comparison of ETR, SVR4, SVR12 and SVR24 between those receiving 8 weeks treatment and those receiving 6 weeks treatment.
Timepoint [2] 0 0
End of treatment- week 6 or week 8 depending on the study arm; 4 weeks post treatment; 12 weeks post treatment; 24 weeks post treatment
Secondary outcome [3] 0 0
Comparison of adherence between those receiving 8 weeks treatment and those receiving 6 weeks treatment
Timepoint [3] 0 0
Baseline to week 6 or week 8 treatment duration
Secondary outcome [4] 0 0
Proportion with early treatment discontinuation
Timepoint [4] 0 0
Baseline through to 6 or 8 weeks depending on the study arm
Secondary outcome [5] 0 0
Proportion with adverse events (including serious adverse events)
Timepoint [5] 0 0
Baseline to week 6 or week 8 treatment duration
Secondary outcome [6] 0 0
Changes in laboratory parameters, including liver function tests (ALT, AST) and haematological indices (haemoglobin, neutrophil count, platelet count)
Timepoint [6] 0 0
Baseline to week 6 or week 8 treatment duration
Secondary outcome [7] 0 0
Emergence of resistance associated variants (RAVs)
Timepoint [7] 0 0
Baseline through to 6 or 8 weeks depending on the study arm
Secondary outcome [8] 0 0
HCV reinfection rate
Timepoint [8] 0 0
Week 208
Secondary outcome [9] 0 0
Changes in sexual and injecting drug use behaviour at SVR 12 and end of follow up
Timepoint [9] 0 0
12 weeks post treatment; week 208
Secondary outcome [10] 0 0
Serum cytokine and ISG expression at baseline and week 4
Timepoint [10] 0 0
Baseline; week 4 on treatment

Eligibility
Key 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*:

1. 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
2. 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 12 months prior to first positive HCV antibody or HCV RNA, with no other cause of acute hepatitis identifiable

OR
3. 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
4. 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 naïve with CD4 T cell count >500 cells/mm3
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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/µL.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/04/2021
Sample size
Target
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Grafton
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
United Kingdom
State/province [3] 0 0
London
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AbbVie
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gail Matthews, MBBS PhD
Address 0 0
Kirby Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02634008