Bulevirtide for Hepatitis D, Chronic

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Federal Budget Institution of Science "Central Research Institute of Epidemiology" of The Federal Service on Customers' Rights Protection and Human Well-being Surveillance, Moscow, Russian Federation
Hepatitis D, Chronic+5 More
Bulevirtide - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a drug can be used to treat chronic hepatitis delta.

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Eligible Conditions

  • Hepatitis D, Chronic
  • Chronic Hepatitis Delta

Treatment Effectiveness

Effectiveness Progress

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

Other trials for Hepatitis D, Chronic

Study Objectives

This trial is evaluating whether Bulevirtide will improve 2 primary outcomes and 15 secondary outcomes in patients with Hepatitis D, Chronic. Measurement will happen over the course of Posttreatment Week 24.

24 weeks
Undetectable HDV RNA 24 weeks after scheduled end of treatment (sustained virological response)
48 weeks
ALT normalization at week 48
Combined response: Undetectable (< LoD) hepatitis Delta virus ribonucleic acid (HDV RNA) or decrease by ≥ 2 log10 IU/ml from baseline and ALT normalization
Undetectable HDV RNA 48 weeks after scheduled end of treatment (sustained virological response)
Undetectable HDV RNA at week 48
Week 240
Change from baseline in liver stiffness as measured by elastography at week 48, 96, 144, 192 and 240
Baseline, Week 144
Change from Baseline in Liver Stiffness as Measured by Elastography at Week 144
Baseline, Week 192
Change from Baseline in Liver Stiffness as Measured by Elastography at Week 192
Baseline, Week 240
Change from Baseline in Liver Stiffness as Measured by Elastography at Weeks 240
Baseline, Week 48
Change from Baseline in Liver Stiffness as Measured by Elastography at Week 48
Baseline, Week 96
Change from Baseline in Liver Stiffness as Measured by Elastography at Week 96
Posttreatment Week 24
Percentage of Participants with Undetectable HDV RNA 24 Weeks after Scheduled End of Treatment (Sustained Virological Response)
Posttreatment Week 48
Percentage of Participants with Undetectable HDV RNA 48 Weeks after Scheduled End of Treatment (Sustained Virological Response)
Up to 144 weeks
Percentage of Participants who Permanently Discontinue Study Drug due to an Adverse Event
Week 48
Combined Response at Week 48: Percentage of Participants with Undetectable (< LoD) Hepatitis Delta Virus Ribonucleic Acid (HDV RNA) or Decrease by ≥ 2 log10 IU/ml From Baseline and ALT Normalization
Percentage of Participants with ALT Normalization at Week 48
Percentage of Participants with Undetectable HDV RNA at Week 48

Trial Safety

Safety Progress

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

Other trials for Hepatitis D, Chronic

Trial Design

6 Treatment Groups

Bulevirtide 10 mg/day, 96 weeks (Arm A)
1 of 6
Bulevirtide 2 mg/day, 144 weeks (Arm B)
1 of 6
Bulevirtide 10 mg/day, 144 weeks (Arm C)
1 of 6
Delayed Treatment
1 of 6
Bulevirtide 2 mg/day
1 of 6
Bulevirtide 10 mg/day
1 of 6
Experimental Treatment

This trial requires 150 total participants across 6 different treatment groups

This trial involves 6 different treatments. Bulevirtide is the primary treatment being studied. Participants will be divided into 6 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Bulevirtide 10 mg/day, 96 weeks (Arm A)
Drug
Participants will receive bulevirtide 10 mg/day for 96 weeks after an observation period of 48 weeks.
Bulevirtide 2 mg/day, 144 weeks (Arm B)
Drug
Participants will receive immediate treatment with bulevirtide 2 mg/day for 144 weeks.
Bulevirtide 10 mg/day, 144 weeks (Arm C)
Drug
Participants will receive immediate treatment with bulevirtide 10 mg/day for 144 weeks.
Delayed Treatment
Drug
Participants will receive delayed treatment with bulevirtide 10 mg/day subcutaneously (SC) for 96 weeks after an observational period of 48 weeks.
Bulevirtide 2 mg/day
Drug
Participants will receive bulevirtide 2 mg/day SC for 144 weeks.
Bulevirtide 10 mg/day
Drug
Participants will receive bulevirtide 10 mg/day SC for 144 weeks.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 48 weeks, 96 weeks, 144 weeks, 192 weeks, 240 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 48 weeks, 96 weeks, 144 weeks, 192 weeks, 240 weeks for reporting.

Closest Location

Cornell University Well Madical College - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The study team will provide a signed and dated informed consent form for the participant to read and sign. show original
The individual has tested positive for serum anti-hepatitis delta virus (HDV) antibody or for serum/ plasma HDV ribonucleic acid (RNA) for at least 6 months before screening. show original
The individual's serum or plasma screened positive for hepatitis D virus RNA. show original
Alanine transaminase level between 1 and 10 times the upper limit of normal. show original
There is no evidence of pregnancy in the female patient. show original
The women in the study were postmenopausal for at least 2 years, surgically sterile, abstinent from heterosexual intercourse, or willing to use highly effective contraception. show original
The person has a serum albumin level of more than 28 grams per liter. show original
Participants in this study must agree to use a highly effective contraception method (double barrier method or barrier contraception in combination with hormonal or intrauterine contraceptive used by female partners) and not to donate sperm throughout the study and for 3 months after the last dose of study medication, regardless of whether they discontinue the study medication during the treatment period. show original

Patient Q&A Section

Can hepatitis d, chronic be cured?

"In the United States, hepatitis D is an infection that is primarily spread through blood transfusions. With proper treatment, infection is highly unlikely. In individuals at high risk of hepatitis D, however, infection should be considered." - Anonymous Online Contributor

Unverified Answer

What are the signs of hepatitis d, chronic?

"The signs of hepatitis d are not specific for CHD as they are with AIH. These same signs of CHD are also present in those with acute viral hepatitis and alcoholic hepatitis. CHD is differentiated from AIH by the absence of circulating S-IgG with reactivity to HEV antigens, and the presence of anti-dsDNA in CHD. This diagnostic feature may be of utility in guiding treatment." - Anonymous Online Contributor

Unverified Answer

What causes hepatitis d, chronic?

"Alcohol consumption is the major cause of hepatitis D. Exposure to non-immune blood products is a minor cause of hepatitis D. There is a relationship between hepatitis D and mental health. The effectivity of immunization against hepatitis D depends on the vaccinating dose. The hepatitis D virus was discovered in 1979 from the blood of an African with chronic liver disease." - Anonymous Online Contributor

Unverified Answer

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

"Overall, we found that hepatitis A, B, and C were commonly diagnosed; however, only one-third of the individuals with hepatitis had chronic HBV, and one-quarter had chronic HCV. Although men were significantly more likely to have hepatitis A than women, this risk was outweighed by a greater number of women with chronic HCV. In the US pediatric population, only hepatitis B was commonly diagnosed, and the majority of children with chronic HBV had HCV." - Anonymous Online Contributor

Unverified Answer

What is hepatitis d, chronic?

"Hepatitis D infection is a chronic infectious disease caused by an icosahedral DNA virus, which is a member of the genus "Deltaretrovirus" of the family "Retroviridae." Hepatitis D has been known to be a major cause of liver cancer (HCC) in some of developing countries of Asia because HCCs occur in more than 82% of people infected with the virus." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hepatitis d, chronic?

"Most patients received some treatment of hepatitis D/V, but more than two thirds had no antiviral therapy within the previous 12 months. Findings from a recent study suggest that most individuals with hepatitis D receive no antiviral therapy after diagnosis." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for hepatitis d, chronic?

"Clinical research on hepatitis D, chronic has progressed significantly. In the past few years, various studies have demonstrated the potential in the treatment option for hepatitis D, chronic. Some clinicians have initiated and continued treatment of hepatitis D, chronic. However, there is a lack of awareness in clinical society to the importance of patient's participation in clinical trials of chronic hepatitis and treatment of hepatitis D, chronic. On one hand, we should not underestimate the value of clinical trials in chronic hepatitis and hepatitis D, chronic. On the other hand, patients should not be ignored because they have the last word in healthcare and are in the position of power." - Anonymous Online Contributor

Unverified Answer

What is the latest research for hepatitis d, chronic?

"This presentation provides recent research on hepatitis D and chronic hepatitis and the relevance of D viral infections to hepatitis D-associated liver disease and HCC. This presentation addresses key questions of how best to tailor medical interventions for hepatitis D and chronic hepatitis treatment." - Anonymous Online Contributor

Unverified Answer

What does bulevirtide usually treat?

"Findings from a recent study of these two studies do not support the current use of bulevirtide to treat the full range of CID that is currently treated with IFN-α alone in addition to the aforementioned immunosuppressive agents." - Anonymous Online Contributor

Unverified Answer

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

"To date, no approved vaccine exists to protect patients with hepatitis D from exposure to this potentially harmful virus. Liver transplants do help some patients; however, they are not always definitive and not always an option. Liver transplantation is the last resort for only the most seriously ill patients. At current time, there is no approved effective monoclonal antibody therapy to treat hepatitis D. Although hepatitis D can be treated with antiviral agents from a broad number of agents, including interferon alpha, ribavirin, and peginterferon alfa as well as hepatitis D antigen immunoassays, the treatment does not eradicate viral infection." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of hepatitis d, chronic?

"Since many factors can cause hepatitis d, chronic, it is difficult to pinpoint the primary cause. It is likely that hepatitis d is caused by numerous factors. It is important, however, to distinguish the hepatitis d, chronic, in the early stages of hepatitis d. Chronic may be the cause of the early stages of hepatitis d, but may be overshadowed by other causes in the late stages of the disease progress." - Anonymous Online Contributor

Unverified Answer

Has bulevirtide proven to be more effective than a placebo?

"BuLev did not reduce fatigue, improve quality of life, or reduce the need for rest in patients with chronic hepatitis B (CHB). Patients can be confidently encouraged to continue therapy when treatment fails, while the rationale of prescribing the drug is questioned. Further research on treatment for fatigue and quality of life in CHB is warranted." - 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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