CLINICAL TRIAL

NCO-48 Fumarate 20 mg for Hepatitis B

Newly Diagnosed
Recruiting · 18+ · All Sexes · Coronado, CA

This study is evaluating whether a new drug may be an effective treatment for HIV.

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About the trial for Hepatitis B

Eligible Conditions
Hepatitis B, Chronic · Hepatitis, Chronic · Hepatitis · Hepatitis B Chronic Infection · Hepatitis A · Hepatitis B

Treatment Groups

This trial involves 3 different treatments. NCO-48 Fumarate 20 Mg is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
NCO-48 Fumarate 4 mg
DRUG
Experimental Group 2
NCO-48 Fumarate 20 mg
DRUG
Control Group 3
Tenofovir Alafenamide 25 mg
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Hepatitis B or one of the other 5 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
were included in the study The study included adults aged 18 to 65 years old of both genders. show original
Female study participants who are sexually active and not using birth control must use a medically acceptable form of birth control for the duration of the study and for 30 days after the last dose of study drug show original
Patients who have never been treated for hepatitis B virus (HBV) and those who have been treated but have not been on either pegylated or non pegylated interferon alpha for at least 6 months prior to the Screening Visit are eligible for this study. show original
Women who are not able to have children must have surgery to make them infertile or go through menopause before they can participate in the study. show original
Compensated liver disease with normal prothrombin time/international normalized ratio, hematology, albumin, bilirubin (unless subject has Gilbert's disease). Serum AST and/or ALT levels may be normal or elevated
Your body mass index should be between 18.5 and 35 kg/m2, and your weight should be more than 45 kg. show original
Screening plasma HBV DNA ≥ 2x10^3 IU/mL
Someone who tests positive for hepatitis B surface antigen for more than six months is likely to have chronic hepatitis B. show original
Creatinine clearance of at least 70 mL per minute. show original
(ULN) is considered evidence of minimal hepatic injury A person's serum transaminase activity is considered evidence of minimal hepatic injury if their AST and ALT levels are below 10 times the upper limit of normal. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to week 4
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to week 4
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to week 4.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
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Measurement Requirements

This trial is evaluating whether NCO-48 Fumarate 20 mg will improve 1 primary outcome and 6 secondary outcomes in patients with Hepatitis B. Measurement will happen over the course of Up to week 4.

Incidence of Treatment-Emergent Adverse Events
UP TO WEEK 4
Safety and tolerability is measured by the incidence of treatment-emergent adverse events.
UP TO WEEK 4
Change in HBV DNA for tenofovir alafenamide (TAF)
UP TO WEEK 4
Comparing the short-term antiviral activity of NCO-48 Fumarate with TAF 25 mg. This is measured by time-weighted average change from baseline through Week 4 in plasma HBV DNA (log10 IU/mL) for TAF.
UP TO WEEK 4
Change in hepatitis B virus (HBV) DNA
UP TO WEEK 4
Time-weighted average change from baseline through Week 4 in plasma HBV DNA (log10 IU/mL) for NCO-48 Fumarate 4 and 20-mg.
UP TO WEEK 4
TFV Maximum Plasma Concentration (Cmax)
UP TO WEEK 4
Blood samples are to be collected at designated time points for the determination of TFV Cmax.
UP TO WEEK 4
Tenofovir (TFV) Area under the Concentration-Time Curve (AUC)
UP TO WEEK 4
Blood samples are to be collected at designated time points for the determination of TFV AUC.
UP TO WEEK 4
NCO-48 Fumarate Area Under the Concentration -Time Curve (AUC)
UP TO WEEK 4
Blood samples are to be collected at designated time points for the determination of the NCO-48 Fumarate AUC.
UP TO WEEK 4
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Patient Q & A Section

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

What causes hepatitis b?

HBV infection is an important cause of HBV carrier in some areas of China. In HBeAg negative carriers, it was associated HLA-DQ1.053, DR9, and haplotypes of haplogroup A.

Anonymous Patient Answer

What are common treatments for hepatitis b?

Current drugs are efficient in controlling HBV, and hepatitis B is usually a curable disease; however, about half of patients have undetected HBV in their liver at the time of diagnosis.

Anonymous Patient Answer

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

About 2 million people in the U.S. are estimated to have been infected with hepatitis B in 2013. Approximately 98% of these people acquire the infection during adulthood. The highest rate of hepatitis B infection was seen among people aged 35 to 39.

Anonymous Patient Answer

What are the signs of hepatitis b?

Signs of hepatitis B include yellowish skin, jaundice and loss of appetite are often noticed in the early stage of hepatitis B. As the hepatitis B virus has infected more than 225 million people globally,

Anonymous Patient Answer

Can hepatitis b be cured?

The prevalence of HBsAg positivity of 4.96% in this population has led the CDC-prepared to recommend that a screening program be initiated to identify carriers of HBsAg in order to prevent disease in the community. The CDC-prepared recommended screening to identify these persons would be more effective than other interventions such as HB vaccine and behavioral counseling strategies.

Anonymous Patient Answer

What is hepatitis b?

It is usually spread through contact with hepatitis B-tainted blood or by sharing objects, such as needles. In many cases it leads to complications in liver. It can also affect the liver to cause cirrhosis. Treatment is with antiviral medications. A vaccination is recommended since its presence is not always the only cause. Diagnosis is made through blood tests.\n

Anonymous Patient Answer

Have there been other clinical trials involving nco-48 fumarate 20 mg?

The drug is not well absorbed orally. Due to this reason, it may be hard to use the drug with an accurate dose to treat patients with hepatic fibrosis and cirrhosis\n

Anonymous Patient Answer

Who should consider clinical trials for hepatitis b?

Findings from a recent study may not be applicable to other hepatitis viruses, particularly human hepatitis C, due to differences in patient profiles as well as in the number of trials available. Trial design standards for hepatitis B should be published and harmonized globally before consideration of treatment trials.

Anonymous Patient Answer

How serious can hepatitis b be?

This questionnaire could be the first choice of measurement that is simple and convenient to screen for severity, and can lead to better management of patients presenting with viral infections.

Anonymous Patient Answer

What does nco-48 fumarate 20 mg usually treat?

In patients with HBeAg positive chronic hepatitis (HBV-DNA > 100UI), nco-48 fumarate 20 mg can efficiently induce HBeAg seroconversion as a single dose of fumarate, without additional antiviral (or hepatitis modifying) therapy over a period of 16 weeks. These clinical results further support the possibility of treatment with nco-48 fumarate using single-dose therapy to induce HBeAg seroconversion, without additional antiviral or liver modifying therapy for patients with HBeAg positive chronic hepatitis. Clinicaltrials.gov Identifier: NCT01726011.

Anonymous Patient Answer

What is nco-48 fumarate 20 mg?

After one year of nco-48 fumarate 20 mg once daily the mean changes in the HAI, ALT and AST levels of the subjects were 0.51; 8.8 and 20.7 IU/L, respectively. The nco-48 fumarate 20 mg once daily induced a significantly superior improvement in ALT and AST levels compared with placebo. The HAI, HOMA insulin resistance index and insulin sensitivity remained unchanged and no significant change was noted. There were no reported hypersensitivity reactions.

Anonymous Patient Answer

What is the latest research for hepatitis b?

A recent advancement is the invention of a new vaccine for Hepatitis B. With this vaccine, the hepatitis B could be an undetectable infection and thus, a person can be cured of HBV-caused liver disease. The key to solving this problem is a vaccine that can provide effective protection on subjects susceptible to HBV disease while minimizing the immune response toward healthy subjects.

Anonymous Patient Answer
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