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Hepatitis B, ChronicPhase 4NCT04070079

Tenofovir Alafenamide With Fine Needle Aspiration Biopsy in Chronic Hepatitis B:

A Phase 4 study testing Tenofovir Alafenamide in people with Hepatitis B, Chronic, run by University Health Network, Toronto at 1 site in Canada.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The objective of this study is to identify immunological mechanisms that contribute to normalization of liver inflammation in chronic hepatitis B (CHB) patients starting the antiviral nucleoside analogue, Tenofovir alafenamide (TAF). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
Tenofovir Alafenamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteCanada
Study dates
29 Jan 2019to 31 Dec 2022
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

  • • Age >18 years
  • Chronic hepatitis B (HBsAg positive ≥ six months)
  • HBeAg positive or negative
  • ALT >19 for females and >30 for males (AASLD criteria)
  • HBV DNA>4 log IU/mL for HBeAg positive and >3 log for HBeAg negative patients
  • No oral antiviral treatment or IFN for ≥6 months
  • Adequate contraception. For males, at least one method of contraception should be used and for females, a barrier contraception method should be used in combination with one other form of contraception.
  • Written informed consent

Who cannot join

  • • Treatment with any investigational drug within 60 days of entry into this protocol
  • Immune-suppressive treatment within the previous 6 months
  • History of decompensated cirrhosis (defined as direct (conjugated)
  • bilirubin > 1.2 × ULN,
  • prothrombin time (PT) > 1.2 × ULN
  • platelets < 100,000/mm3
Show all 17Show fewer
  • serum albumin < 3.5 g/dL
  • prior history of clinical hepatic decompensation (jaundice in the presence of cirrhosis, ascites, gastric bleeding, oesophageal varices or encephalopathy)
  • Liver transplantation
  • Co-infection with hepatitis C virus, hepatitis D virus or HIV
  • Other significant liver disease: alcoholic liver disease, drug-related liver disease, auto-immune hepatitis, hemochromatosis, Wilson's disease or alpha-1 antitrypsin deficiency
  • Estimated glomerular filtration rate <50 mL/min/1.73m2 or any significant renal disease.
  • Alpha-fetoprotein > 50 ng/ml
  • Pregnancy, breast-feeding
  • Other significant medical illness that might interfere with this study: significant pulmonary dysfunction in previous 6 months, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g. HIV positivity, auto-immune diseases, organ transplants other than cornea and hair transplant)
  • Substance abuse, such as alcohol (≥80 g/day), I.V. drugs and inhaled drugs in past 2 years. Current methadone usage is allowed.
  • Any other condition which in the opinion of the investigator would make the patient unsuitable for enrolment, or could interfere with the patient participating in and completing the study

Trial locations and contacts

1 site in 1 country.

Canada1 site, 1 recruiting

  • Toronto General Hospital

    Toronto, Ontario, M3G 2C4

    Pujitha Rao, 4163404800 ext. 6651, pujitha.rao@uhn.ca

    Recruiting

Other trials in Canada

About this study

Official title: Evaluation of Intrahepatic Immune and Virological Response to Tenofovir Alafenamide With Fine Needle Aspiration Biopsy in Chronic Hepatitis B: an Investigator-Initiated, Cohort Study

The objective of this study is to identify immunological mechanisms that contribute to normalization of liver inflammation in chronic hepatitis B (CHB) patients starting the antiviral nucleoside analogue, Tenofovir alafenamide (TAF).

Read the detailed description

Investigator-initiated, phase 4 study in which recruited patients will receive, TAF 25mg once daily, for 48 weeks (Figure 1 and Table 1). The total duration of the study to End of Follow-up (EOF) will be 48 weeks. After Week 48, participants will be offered 2 years of TAF therapy. Sample collection 0, 12, 24 w was chosen to analyze immune responses based on ALT normalization rates. This mono-center study will be conducted at Toronto Centre for Liver Disease, Canada.

Being tested
Tenofovir Alafenamide
Medical subject headings
Hepatitis B, Chronic

What participants receive

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

  • Tenofovir AlafenamideDrug

    TAF 25mg once daily orally, for 48 weeks

Study groups in NCT04070079
Study groupRoleWhat they receive
Tenofovir AlafenamideOtherTenofovir Alafenamide 25mg, Dosed orally, once daily with or without food.
Receives: Drug: Tenofovir Alafenamide

What is being measured

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

  1. TAF-mediated reduction of inflammatory gene expression in intraheaptic immune cells

    Longitudinal samples collected from each patient will be used to measure changes in intrahepatic and peripheral innate and adaptive immune composition, function and gene expression from baseline to ALT normalization after starting TAF.

    Measured: 3 years

  2. TAF-mediated reduction of serological markers of HBV replication

    Existing and experimental biomarkers of HBV replication will be measured to compare the viral response to the immune response

    1. HBsAg/HBeAg seroclearance
    2. HBsAg/HBeAg seroconversion,
    3. Serum quantitative HBsAg/HBeAg levels,
    4. Serum HBV DNA levels
    5. HBV RNA levels
    6. Hepatitis B core-related Antigen (HBcrAg) levels;
    7. ALT levels.

    Measured: 3 years

  3. TAF-mediated reduction of intrahepatic HBV replication intermediates and cccDNA levels

    HBV replication intermediates and cccDNA measured as copies/mg of liver tissue

    Measured: 3 years

Timeline

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

  1. First posted28 Aug 2019
  2. Study start29 Jan 2019
  3. Primary completion30 Aug 2022 (estimated)
  4. Study completion31 Dec 2022 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04070079
Sponsor's protocol ID
CO-US-320-4667
Status last verified
Aug 2019
First submitted
29 Mar 2019
Last updated
28 Aug 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: It is undecided yet.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tenofovir Alafenamide in people with Hepatitis B, Chronic, run by University Health Network, Toronto at 1 site in Canada.

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 8 inclusion and 17 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TAF-mediated reduction of inflammatory gene expression in intraheaptic immune cells (time frame: 3 years). The study lists 3 primary outcomes in all. 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 NCT04070079.

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 28 Aug 2019.

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