EXPANDED-ACCESS PROGRAM FOR THE TREATMENT OF CHRONIC HEPATITIS D WITH BRELOVITUG (BTG-EAP)
Brelovitug is designed to target or bind to a key protein on the surface of hepatitis D and hepatitis B viruses, known as the hepatitis B surface antigen (HBsAg). By targeting this protein, brelovitug may help neutralize virus particles and support their removal from the bloodstream.
The aim of this expanded-access program (EAP) is to make brelovitug available to patients with Chronic Hepatitis D (CHD) who are in medical need, cannot benefit from any other comparable authorized treatment, and cannot participate in any available clinical trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This expanded access program provides brelovitug at no cost to eligible adults with chronic hepatitis D who have no comparable approved treatment option, cannot tolerate or continue approved therapy, or are not candidates for approved therapy based on the treating physician's clinical judgment.
Patients must be unable or ineligible to participate in an available brelovitug clinical trial. All patients must meet the following criteria to be considered eligible for program entry:
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Informed consent and assent provided, as applicable per Institutional Review Board (IRB) / Ethic Committee (EC), and willing to comply with the procedures and assessments.
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Medical diagnosis of Chronic Hepatitis Delta with confirmatory hepatitis delta virus (HDV) antibody and RNA
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On stable nucleos(t)ide therapy for Chronic Hepatitis B for duration of EAP and after EAP at direction of treating physician.
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Patients aged ≥18 years for whom, in the judgment of the treating physician, treatment with brelovitug is clinically appropriate based on efficacy, safety, or other relevant clinical considerations.
- Patients who are intolerant, non-compliant, ineligible or who discontinue a currently approved therapy; or patients who are not candidates for a currently approved therapy in the clinical judgment of the treating physician.
Study Type
Expanded Access Type
- Treatment IND/Protocol
Contacts and Locations
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44106
- Available
- University Hospitals Cleveland Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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Informed consent and assent provided, as applicable per Institutional Review Board (IRB) / Ethic Committee (EC), and willing to comply with the procedures and assessments.
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Medical diagnosis of Chronic Hepatitis Delta with confirmatory HDV antibody and RNA
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On stable nucleos(t)ide therapy for Chronic Hepatitis B for duration of EAP and after EAP at direction of treating physician.
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Patients aged ≥18 years for whom, in the judgment of the treating physician, treatment with brelovitug is clinically appropriate based on efficacy, safety, or other relevant clinical considerations.
- Patients who are intolerant, non-compliant, ineligible or who discontinue a currently approved therapy; or patients who are not candidates for a currently approved therapy in the clinical judgment of the treating physician.
Exclusion Criteria:
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Eligible and access to any ongoing CHD clinical trials designed to establish safety and efficacy.
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Pregnant, intends to become pregnant or lactating females.
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Known hypersensitivity to brelovitug or any of its excipients.
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Any clinically significant medical condition, comorbidity, laboratory abnormality, or other clinical circumstance that, in the judgment of the treating physician and/or Sponsor's Medical Reviewer, would place the patient at an unacceptable risk from treatment with brelovitug or result in an unfavorable benefit-risk assessment. Such conditions may include, but are not limited to, clinically significant cardiovascular, hepatic, gastrointestinal, pulmonary, neurologic, infectious, or renal disease.
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Current or prior hepatic decompensation (ascites, hepatic encephalopathy, variceal hemorrhage, etc) or Child-Turcotte-Pugh (CTP) Class B or C cirrhosis.
- Clinically significant liver disease attributable to an etiology other than HBV or HDV that, in the judgment of the treating physician and/or Sponsor's Medical Reviewer, would result in an unfavorable benefit-risk assessment for treatment with brelovitug. Patients with compensated cirrhosis up to CPT A6 may be considered on a case-by-case basis following review and approval by the Sponsor's Medical Reviewer, provided the potential benefits of treatment are considered to justify the potential risks.
- Presence of any disease, condition, concomitant therapy, or other clinical circumstance that is known or reasonably expected to significantly alter the absorption, distribution, metabolism, or excretion of brelovitug, or otherwise adversely affect its safety or intended pharmacologic activity, and that, in the judgment of the treating physician and/or Sponsor's Medical Reviewer, would make treatment with brelovitug clinically inappropriate.
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BTG-EAP
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