Evaluating RBD1016 for treating chronic hepatitis D

A Phase 2a, Multicentre Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of RBD1016 in Participants With Chronic Hepatitis D Virus Infection, Including a Randomised, Single Blinded, Placebo-controlled Exploratory Part

This study is testing a new treatment called RBD1016 to see if it can help adults with chronic hepatitis D lower their virus levels while they continue their regular medication.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Ribocure Pharmaceuticals AB (Industry-sponsored)
• Locations: 2 sites (Stockholm and 1 other locations)
• Trial ID: NCT06649266 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy, safety, and pharmacokinetics of RBD1016 in adults with chronic hepatitis D virus infection. Participants will be randomly assigned to receive either RBD1016 or a placebo, with both groups continuing stable nucleoside analogue treatment. The trial will involve multiple visits for checkups and tests over a period of 16 weeks, during which the treatment will be blinded to participants. The primary focus is to determine if RBD1016 can effectively reduce HDV RNA levels and to monitor any potential side effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with documented chronic hepatitis D and B infections, and no liver cirrhosis.

Not a fit: Patients with significant liver cirrhosis or those with clinically significant laboratory abnormalities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from chronic hepatitis D.

How similar studies have performed: While there have been various approaches to treating hepatitis D, the specific use of RBD1016 is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Willing and able to give written informed consent for participation in the trial.
2. Male or female participant aged 18 to 65 years, inclusive.
3. Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2 at the time of the screening visit.
4. Documented evidence of HDV infection in medical history, i.e., HDV antibodies (HDVAb) and/or HDV RNA positive test results within at least 6 months prior to screening.
5. Documented evidence of HBV infection in medical history, i.e., HBsAg and/or HBV DNA positive test results within at least 6 months prior to screening.
6. Documented absence of liver cirrhosis, defined as an LSM ≥ 10 kPa measured on FibroScan® elastography at screening.

Exclusion Criteria:

1. Laboratory results at screening as follows, or any clinically significant laboratory parameter outliers that may interfere with the evaluation of efficacy and/or safety in the trial, at the discretion of the Investigator:

   * α-fetoprotein (AFP) \> 50 µg/L.
   * Albumin concentration \< 3.0 g/dL.
   * International normalized ratio (INR) \> 1.5.
   * Platelet count \< 90 × 109/L.
   * Direct bilirubin \> 2 × ULN, Gilbert syndrome excluded.
   * Creatinine concentration \> 1.5 × ULN.
   * Creatinine clearance \< 60 mL/min, according to the Cockcroft-Gault equation.
2. Positive result at screening for hepatitis C virus (HCV) and/or human immunodeficiency virus (HIV) and/or prior diagnosis of syphilis, acute hepatitis A and/or acute hepatitis E.
3. Prior diagnosis of other liver diseases of non-HBV or non-HDV aetiology, including autoimmune liver disease (e.g., autoimmune hepatitis, primary biliary cholangitis or primary sclerosing cholangitis), inherited metabolic liver disease (e.g., haemochromatosis, Wilson's disease, familial intrahepatic cholestasis), drug-induced liver disease and/or non alcoholic steatohepatitis (NASH) assessed as moderate or above, at the discretion of the Investigator.
4. Prior or current diagnosis of liver cirrhosis.
5. History of or active hepatic decompensation, e.g., ascites, variceal bleeding or hepatic encephalopathy, at the discretion of the Investigator.
6. History of organ transplantation, previous or concurrent HCC or imaging finding suggesting malignant liver lesions, at the discretion of the Investigator.
7. Signs of liver malignancy in abdominal ultrasound at screening.

Where this trial is running

Stockholm and 1 other locations

• Medicinsk enhet för Infektionssjukdomar, Karolinska Universitetssjukhuset Huddinge — Stockholm, Sweden (Recruiting)
• Infektionskliniken, Danderyds sjukhus — Stockholm, Sweden (Recruiting)

Study contacts

• Study coordinator: Rebeckha Magnusson Head of Clin Ops and QA

Conditions Chronic Hepatitis D