Treatment for Chronic Hepatitis B

Toronto General Hospital, Toronto, Canada
Chronic Hepatitis B
Eligibility
18+
All Sexes

Study Summary

This trial will help researchers understand how the antiviral drug Tenofovir alafenamide helps to reduce liver inflammation in patients with chronic hepatitis B.

Eligible Conditions
  • Chronic Hepatitis B

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

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HA35 Treatment Group
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Study Objectives

3 Primary · 0 Secondary · Reporting Duration: 3 years

3 years
TAF-mediated reduction of inflammatory gene expression in intraheaptic immune cells
TAF-mediated reduction of intrahepatic HBV replication intermediates and cccDNA levels
TAF-mediated reduction of serological markers of HBV replication

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
HA35 Treatment Group
2
Selgantolimod
2
GSK3228836

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

0 Treatment Group

15 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · Phase 4

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,396 Previous Clinical Trials
474,368 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are over 18 years of age.
You have chronic hepatitis B, with a positive HBsAg for at least six months.
You have tested either positive or negative for Hepatitis B e Antigen.
You have given written consent.
Females should have an ALT value higher than 19 and males should have a greater-than 30 level, according to American Association for the Study of Liver Diseases criteria.
Males should employ at least one form of contraception and females should use a barrier method in conjunction with an additional contraceptive option.
You have not received oral antiviral treatment or interferon therapy for a period of at least 6 months.
You have an HBV DNA level of at least 4 log IU/mL if you are HBeAg positive, or 3 log IU/mL if you are HBeAg negative.
References

Frequently Asked Questions

Are there any antecedent investigations into this therapeutic approach?

"Presently, 73 studies investigate this therapeutic intervention. Of which, 16 are in Phase 3 of their trials. Primarily situated near Myslowice, Maryland; 1430 locations facilitate research related to this treatment regimen." - Anonymous Online Contributor

Unverified Answer

What safety assessments have been made to ensure this treatment is secure for individuals?

"As this is a Phase 4 trial, with an approved treatment protocol and existing data supporting safety, it was assigned the highest rating of 3." - Anonymous Online Contributor

Unverified Answer

How many human participants are being evaluated in this clinical research?

"Verified. Reports from clinicaltrials.gov demonstrate that this particular trial is actively recruiting patients, having first been posted on 29th January 2019 and last updated 23rd August 2019. It requires 15 participants to be admitted across one site." - Anonymous Online Contributor

Unverified Answer

Are there openings presently available in this clinical trial?

"Affirmative. Reports on clinicaltrials.gov show that the trial, which was first advertised in January of 2019 is currently seeking participants. In total, 15 patients are sought to be recruited from a single medical site." - Anonymous Online Contributor

Unverified Answer

What indications is this treatment typically prescribed for?

"This medication is commonly prescribed for people without a prior history of treatment. Furthermore, it may be recommended to those with HIV-1 and weight at least 35 kg who have not developed resistance to darunavir." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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