Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of RBD1016 in Participants With Chron… (NCT06649266) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of RBD1016 in Participants With Chronic Hepatitis D
Sweden14 participantsStarted 2024-08-21
Plain-language summary
The goal of this clinical trial is to learn if drug RBD1016 works to treat chronic hepatitis D virus infection in adults. It will also learn about the safety of drug RBD1016. The main questions it aims to answer are:
Does drug RBD106 reduce the HDV RNA levels? What medical problems may participants experience when taking drug RBD1016? Researchers will compare drug RBD1016 to a placebo to see if drug RBD1016 works to treat chronic hepatitis D.
Participants will:
Receive drug RBD1016 or a placebo several times throughout the trial. Visit the clinic once every 4-6 weeks for checkups and tests.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Willing and able to give written informed consent for participation in the trial.
✓. Male or female participant aged 18 to 65 years, inclusive.
✓. Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2 at the time of the screening visit.
✓. 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.
✓. 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.
✓. Documented absence of liver cirrhosis, defined as an LSM ≥ 10 kPa measured on FibroScan® elastography at screening.
Exclusion criteria
✕. 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:
✕. 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.
What they're measuring
1
Mean change (log10 value) vs. baseline in HDV RNA levels in plasma at end of trial (Week 60).
✕. 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.
✕. Prior or current diagnosis of liver cirrhosis.
✕. History of or active hepatic decompensation, e.g., ascites, variceal bleeding or hepatic encephalopathy, at the discretion of the Investigator.
✕. History of organ transplantation, previous or concurrent HCC or imaging finding suggesting malignant liver lesions, at the discretion of the Investigator.
✕. Signs of liver malignancy in abdominal ultrasound at screening.