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A Study to Evaluate Tobevibart+Elebsiran in Participants with Chronic HDV Infection Not Virologically Suppressed with Bulevirtide
EU CTIS ID: 2024-519282-22-00
What this study is testing
Part I: To evaluate the antiviral efficacy of tobevibart+elebsiran in participants with BLV treatment experience Part 2: To evaluate the efficacy of tobevibart+elebsiran in achieving SVR in participants who systematically interrupt treatment
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult men and women aged ≥ 18 years (or age of legal consent, whichever is older) to ≤ 70 years at the time of signing informed consent
- HDV RNA ≥ 500 IU/mL at screening
- Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1
- Noncirrhotic or compensated cirrhotic liver disease at screening
- Body mass index (BMI) ≥ 18 kg/m2 to ≤ 40 kg/m2
- On NRTI therapy against HBV for at least 12 weeks prior to Day 1 or have HBV DNA < 10 IU/mL at screening, and currently on locally approved NRTI therapy. Participants must be on one of the following NRTI therapies starting at Day 1: tenofovir alafenamide (taken alone or as part of a fixed-dose combination therapy), tenofovir disoproxil fumarate (taken alone or as part of a fixed-dose combination therapy), or entecavir
You likely can't join if
- Current or prior history of any of the following: a. Clinically significant laboratory abnormalities, co-morbid medical condition (other than HBV/HDV coinfection) or planned medical procedure that may interfere with the participant’s treatment, assessment, or compliance with the protocol. b. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy. c. Current or previous (within 24 months of screening) clinically identified hepatic decompensationd. d. Bone marrow, peripheral blood stem-cell or solid organ transplantation e. Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years. f. Malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; ductal carcinoma in situ and cervical carcinoma in situ is allowed if appropriately treated prior to screening); participants under evaluation for malignancy are not eligible. g. Significant drug allergy (such as anaphylaxis or hepatotoxicity)
- One or more additional known primary or secondary causes of liver disease, other than hepatitis B or hepatitis D (ie, alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, Wilson’s disease, other congenital or metabolic condition affecting the liver, congestive heart failure, etc).
- History of clinically significant immune complex disease as determined by the Investigator
- History of anaphylaxis, allergic reactions, hypersensitivity, or intolerance to study drug, study drug component (ex. Oligonucleotide and/or GalNAc), its metabolites or excipients
- Participants with active HCV (participants with HCV antibodies can be enrolled if screening HCV RNA PCR test is negative).
- Participants with uncontrolled HIV-1 infection (defined as HIV-1 >200 copies/mL or CD4+ T-cell counts < 500/mm3 is within the last 12 months) or any HIV-2 infection.
See the full eligibility criteria
Who can join
- Adult men and women aged ≥ 18 years (or age of legal consent, whichever is older) to ≤ 70 years at the time of signing informed consent
- HDV RNA ≥ 500 IU/mL at screening
- Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1
- Noncirrhotic or compensated cirrhotic liver disease at screening
- Body mass index (BMI) ≥ 18 kg/m2 to ≤ 40 kg/m2
- On NRTI therapy against HBV for at least 12 weeks prior to Day 1 or have HBV DNA < 10 IU/mL at screening, and currently on locally approved NRTI therapy. Participants must be on one of the following NRTI therapies starting at Day 1: tenofovir alafenamide (taken alone or as part of a fixed-dose combination therapy), tenofovir disoproxil fumarate (taken alone or as part of a fixed-dose combination therapy), or entecavir
What rules you out
- Current or prior history of any of the following: a. Clinically significant laboratory abnormalities, co-morbid medical condition (other than HBV/HDV coinfection) or planned medical procedure that may interfere with the participant’s treatment, assessment, or compliance with the protocol. b. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy. c. Current or previous (within 24 months of screening) clinically identified hepatic decompensationd. d. Bone marrow, peripheral blood stem-cell or solid organ transplantation e. Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years. f. Malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; ductal carcinoma in situ and cervical carcinoma in situ is allowed if appropriately treated prior to screening); participants under evaluation for malignancy are not eligible. g. Significant drug allergy (such as anaphylaxis or hepatotoxicity)
- One or more additional known primary or secondary causes of liver disease, other than hepatitis B or hepatitis D (ie, alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, Wilson’s disease, other congenital or metabolic condition affecting the liver, congestive heart failure, etc).
- History of clinically significant immune complex disease as determined by the Investigator
- History of anaphylaxis, allergic reactions, hypersensitivity, or intolerance to study drug, study drug component (ex. Oligonucleotide and/or GalNAc), its metabolites or excipients
- Participants with active HCV (participants with HCV antibodies can be enrolled if screening HCV RNA PCR test is negative).
- Participants with uncontrolled HIV-1 infection (defined as HIV-1 >200 copies/mL or CD4+ T-cell counts < 500/mm3 is within the last 12 months) or any HIV-2 infection.
- Participants with HAV (participants who are HAV IgM positive can be enrolled if asymptomatic and HAV IgG positive).
- Participants with HEV (participants who are HEV IgM positive can be enrolled if asymptomatic and HEV IgG positive). In cases where acute infection status cannot be determined by serologies a serum or stool HEV RT-PCR can be obtained. The participant is ineligible if PCR is positive
- Current therapy or therapy within 24 weeks of of first study intervention administration with an immunomodulatory agent (eg, IFN-α), immune checkpoint inhibitors, immunosuppressants (eg, diseasemodifying antirheumatic drugs), cytotoxic or chemotherapeutic agent, or chronic systemic corticosteroids (equivalent of 10mg prednisone QD).
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.