Study to Assess Efficacy and Safety of Bulevirtide in Participants With Chronic Hepatitis Delta (… (NCT03852719) | Clinical Trial Compass
CompletedPhase 3
Study to Assess Efficacy and Safety of Bulevirtide in Participants With Chronic Hepatitis Delta (CHD)
United States, Germany150 participantsStarted 2019-04-17
Plain-language summary
The primary objective of this study is to evaluate the efficacy of bulevirtide administered subcutaneously (SC) for 48 weeks at a dose of 2 mg or 10 mg once daily for treatment of chronic hepatitis delta (CHD) in comparison to delayed treatment.
The main goal of this study is to determine the effectiveness of bulevirtide in participants randomized to bulevirtide 2 mg or 10 mg once daily SC as compared to participants randomized to delayed treatment for 48 weeks. Treatment will continue through Week 144 (participants randomized to delayed treatment will change to bulevirtide 10 mg once daily SC after Week 48 through Week 144). All participants will be followed off-treatment for an additional 96 weeks.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Provision of signed and dated informed consent form.
✓. Positive serum anti-hepatitis delta virus (HDV) antibody results or polymerase chain reaction (PCR) results for serum/ plasma HDV ribonucleic acid (RNA) for at least 6 months before screening.
✓. Positive PCR results for serum/plasma HDV RNA at screening.
✓. Alanine transaminase level \> 1 x upper limit of normal (ULN), but less than 10 x ULN.
✓. Serum albumin \> 28 g/L.
✓. Negative urine pregnancy test for females of childbearing potential.
✓. Inclusion criteria for females:
✓. Individuals must agree to use a highly effective contraception (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 the study medication for individuals discontinued during the treatment period.
Exclusion criteria
What they're measuring
1
Percentage of Participants With Combined Response at Week 48
. Child-Pugh hepatic insufficiency score over 7 points. Uncomplicated oesophageal varices allowed; Individuals with current bleeding or ligation, or history of bleeding or ligation within the last 2 years are excluded.
✕. Hepatitis C virus (HCV) or uncontrolled human immunodeficiency virus (HIV) coinfection. Individuals with HCV antibodies can be enrolled, if screening HCV RNA test is negative. Individuals with HIV infection can be enrolled if cluster of differentiation (CD4+) cell counts are \>500/mL and HIV RNA is below limit of detection for at least 12 months.
✕. Creatinine clearance \< 60 mL/min as estimated using Cockcroft-Gault formula.
✕. Total bilirubin ≥ 34.2 µmol/L. (Individuals with higher total bilirubin values may be included after the consultation with the Study Medical Monitor, if such elevation can be clearly attributed to Gilbert's syndrome associated with low-grade hyperbilirubinemia.)
✕. Evidence of an active or suspected malignancy or a history of malignancy, or an untreated pre-malignancy disorder within the last 5 years (with the exception of successfully treated carcinoma of the cervix in situ and successfully treated basal cell carcinoma and squamous cell carcinoma not less than 1 year prior to screening \[and no more than 3 excised skin cancer within the last 5 years prior to screening\]) or history of hepatic carcinoma.
✕. Systemic connective tissue disorders.
✕. New York Heart Association (NYHA) class III-IV congestive heart failure.
✕. Individuals with uncontrolled arterial hypertension: systolic blood pressure \> 150 mm Hg and/ or diastolic blood pressure \> 100 mm Hg at Screening.