SOC NrtI for Hepatitis, Chronic

Phase-Based Estimates
1
Effectiveness
2
Safety
Westmead Hospital, Westmead, Australia
Hepatitis, Chronic+5 More
SOC NrtI - Drug
Eligibility
18 - 65
All Sexes
Eligible conditions
Hepatitis, Chronic

Study Summary

This study is evaluating whether a drug called vebicorvir (VBR) in combination with a drug called AB-729 is safe and effective in people with chronic hepatitis B infection (cHBV) receiving a standard of care nucleos(t)ide/reverse transcriptase inhibitor (S

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Eligible Conditions

  • Hepatitis, Chronic
  • Hepatitis A
  • Hepatitis B, Chronic
  • Hepatitis
  • Hepatitis B
  • Hepatitis B Chronic Infection

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether SOC NrtI will improve 3 primary outcomes and 11 secondary outcomes in patients with Hepatitis, Chronic. Measurement will happen over the course of Week 48.

Week 40
Plasma Levels of AB-729
Week 96
Change from Baseline in Mean log10 HBV RNA
Change from Baseline in Mean log10 Hepatitis B Core-related Antigen (HBcrAg)
Change from Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg)
Number of Participants with Normal Alanine Aminotransferase (ALT)
Week 48
Plasma Levels of SOC NrtI (ETV, TDF, TAF)
Week 52
Plasma Levels of VBR
Week 96
Number of Participants with Serum HBsAg Below the Lower Limit of Quantitation (<LLOQ)
Up to 96 weeks
Number of Participants With One or More Abnormal Laboratory Result
Number of Participants with One or More Adverse Events
Number of Participants with Premature Study Discontinuation
Week 48
Number of Participants with HBV Deoxyribonucleic Acid (DNA) not Detected (<5 International Units/mL)
Number of Participants with HBV Ribonucleic Acid (RNA) <LLOQ
Number of Participants with HBsAg Seroconversion

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
VBR + AB-729 + SOC NrtI

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. SOC NrtI is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

VBR + AB-729 + SOC NrtIParticipants with cHBV will receive VBR + AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: before dosing at baseline (day 1) and at pre-specified time points up to 48 weeks, and at week 52
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly before dosing at baseline (day 1) and at pre-specified time points up to 48 weeks, and at week 52 for reporting.

Closest Location

(G.I.R.I.) GI Research Institute - Vancouver, Canada

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
is the main determinant of outcome in patients with hepatitis C The main determinant of outcome in patients with hepatitis C is lack of bridging fibrosis or cirrhosis. show original
The patient is in good general health and is only infected with cHBV show original
of dosing This is a requirement for any female participants taking part in the study show original
The HBsAg level is greater than or equal to 100 international units per milliliter at screening. show original
is required of all personnel who will have contact with female Ebola patients in the United States show original
BMI ranges from 18 to 36 kg/m2, and a person's minimum body weight must be at least 45 kg. show original
HBV infection that has been present for at least six months prior to being screened is considered chronic. show original
The person has not had the Hepatitis B 'e' antigen (HBeAg) for at least 3 months prior to the Screening Visit, and they still do not have it at the Screening Visit. show original
: They had no detectable hepatitis B virus in their blood for at least six months before the test. show original
, the estimated probability of virologic failure (VLF) was <3% For more than 12 months, on a stable regimen of ETV, TDF, or TAF, the estimated probability of virologic failure was less than 3%. show original

Patient Q&A Section

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

How many people get hepatitis, chronic a year in the United States?

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There is an annual prevalence of hepatitis, chronic in the U.S. that far exceeds the prevalence of hepatitis, chronic in the WHO world. Further research in this area is warranted.

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What causes hepatitis, chronic?

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Hepatitis, chronic is more common in Asians and Ameras, and is due to HCV infection. It is estimated that about 7% of hepatitis, chronic individuals are carriers, that is, they have chronic HCV infection but are asymptomatic.

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Can hepatitis, chronic be cured?

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Although a cure may not be possible by any currently proven treatment modality, several factors seem to confer a reduced risk of progression to cirrhosis with time. These factors include a virologic control of the hepatitis C virus, a low level of ALT activity within the normal range, a long pretreatment duration, and lack of liver-related symptoms. Liver transplantation remains the ideal treatment for liver cirrhosis secondary to HCV-related cirrhosis.

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What is hepatitis, chronic?

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Chronic, or long-standing infection due to hepatitis B viruses, is the most significant risk factor for liver cancer. Other risk factors that contribute to liver cancer are cirrhosis, exposure to non-steroidal anti-inflammatory drugs, alcohol misuse, hepatitis C virus infection, and non-alcoholic fatty liver disease. In this article, we review the risk of hepatitis B virus as a contributor to liver cancer. Further, we describe the diagnosis and the treatment of hepatitis.

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What are the signs of hepatitis, chronic?

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Hepatitis is not usually noticed in this population. Symptoms such as abdominal pain and jaundice are often non-specific. Fever, an enlarged liver and a painful spleen are also suggestive of hepatitis. The presence of symptoms suggestive of coexistent diseases should prompt further investigation. Abnormal laboratory findings are the main signs associated with viral hepatitis.

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What are common treatments for hepatitis, chronic?

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There is no specific treatment for hepatitis. In addition, there is no cure for liver disease, so treatment is aimed toward management of symptoms and maintaining liver function. There is no definitive proof that antibiotics confer any benefit in the treatment of viral hepatitis.

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Have there been any new discoveries for treating hepatitis, chronic?

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Recently new drugs for treating hepatitis C have been introduced. Patients who are infected or have contracted hepatitis B will receive a more definitive approach than those infected with hepatitis C alone. Some patients with cirrhosis may benefit from transplantation with good quality patient-survival rates.

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Is soc nrti typically used in combination with any other treatments?

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The data collected from this study show that an individual from the general Indian population will need to carry a total of 9 drugs (5+1+3) a day to get treatment for NRTI. There are also other hurdles like cost to be overcome in the treatment of NRTI.

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Does hepatitis, chronic run in families?

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The incidence of chronic HCV in a family is associated with a high frequency of PDA. In particular, PDA in a boy with chronic HCV is likely to be caused by the interaction of the male X chromosome with the viral genome. Although gender predisposition alone cannot be considered enough to explain the high female to male HCV prevalence, we propose that it may be partly connected to HCV-related X chromosomal conditions, which may interact with gender and/or hepatitis C virus-related modifiers. To our knowledge, this report is the first to show genetic associations of PDA and HCV infection in an Indian population.

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Has soc nrti proven to be more effective than a placebo?

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In this small study, we can show that soc only significantly improved liver enzymes, however, this improvement was neither significantly better nor worse than the control group. This is a new finding, and we need to explore this further before adopting the method at the general population. This method could prove useful at the beginning and for all the patients with chronic viral hepatitis.

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What is the primary cause of hepatitis, chronic?

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Hepatitis is a spectrum of diseases with different causes and manifestations, varying from asymptomatic and subclinical to frank overt disease. Chronic hepatitis is a heterogeneous, complex, and often chronic disease with many possible causes. The main causative factors are viral (hepatitis B virus [HBV] and hepatitis C virus [HCV]), immunologic (such as with autoimmune hepatitis), and idiopathic. These factors cause hepatocellular carcinoma, hepatic fibrosis, and immune mediated hepatitis. Other causes include non-hepatic causes (chronic myelogenous leukemia, multiple sclerosis, thalassemia, sickle cell disease, and others).

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Is soc nrti safe for people?

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Data from a recent study of this study show that social nrti may increase the risk of liver damage and death in HIV/HCV coinfectious patients.

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