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Active, not recruitingNCT06649266Updated Feb 3, 2026

Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of RBD1016 in Participants With Chronic Hepatitis D

A Phase 2 interventional study of RBD1016 and Placebo in Chronic Hepatitis D, sponsored by Ribocure Pharmaceuticals AB. Active, not recruiting at 2 sites in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-03.

Sponsored by Ribocure Pharmaceuticals AB · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

This is a multicentre, randomised, partly blinded, placebo-controlled clinical trial to evaluate the efficacy, safety and pharmacokinetics (PK) of RBD1016 subcutaneous injections in participants with chronic HDV infection.

First part of the trial: There will be 2 treatment groups - an active group (n=10) and a deferred active group (n=5), with participants allocated randomly. In the active group, participants will receive RBD1016. In the deferred active group, participants will receive 4 doses of placebo followed by deferred treatment with doses of RBD1016.

Both groups will be on a stable nucleoside analogue (NA) treatment course during the trial . All participants will be blinded to the trial treatment for the 16 weeks after the first dose. Then, investigators and other clinic staff will be unblinded, i.e., they will know which treatment the participants receive at all times.

Open-label extension part (site 01 only): continued IMP-treatment with additionally 3 doses of IMP administered 12 weeks apart. This part of the trial is conducted to collect long-term safety data and further exploratory efficacy measures. Only participants who may benefit from continued treatment in the ,trial, according to the judgement of the investigator, will be eligible for the open-label extension part of the trial.

02

Conditions studied

  • Chronic Hepatitis D

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03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Active group

    Participants will receive RBD1016 (subcutaneous injections).

    Drug: RBD1016

  • Other
    Deferred active group

    Participants will receive 4 doses of placebo (subcutaneous injections) followed by RBD1016 (subcutaneous injections).

    Drug: RBD1016 · Drug: Placebo

Interventions

  • DrugRBD1016

    RBD1016, active drug.

  • DrugPlacebo

    Placebo that is identical in appearance and volume to the doses of active IMP.

05

What researchers measure

Primary outcomes

  1. Mean change (log10 value) vs. baseline in HDV RNA levels in plasma at end of trial (Week 60).

    Time frame: 60 weeks

Secondary outcomes

  1. Frequency, intensity and seriousness of reported AEs, SAEs and AEs of special interest (AESIs) during the trial.

    Number and percentage of participants with AEs, SAEs and AEs of interest. All reported AE terms will be coded using Medical Dictionary for Drug Regulatory Affairs (MedDRA).

    Time frame: 60 weeks

  2. Mean change (log10 value) in HBsAg levels vs. baseline, at end of trial (Week 60).

    Time frame: 60 weeks

  3. Proportion of participants with positive immunogenicity, measured as plasma concentrations of anti-drug antibodies (ADAs), at each evaluation time point up to end of the study at week 60.

    Time frame: 60 weeks

  4. Mean maximum change (log10 value) in HDV RNA levels in plasma vs. baseline, at any timepoint during the study, and up to the end of study at Week 60.

    Mean maximum change refers to the average of the largest changes in HDV RNA levels.

    Time frame: Up to 60 weeks

  5. Mean maximum change (log10 value) in HBsAg levels vs. baseline, at any timepoint during the study, and up to end of study at Week 60.

    Mean maximum change refers to the average of the largest changes in HBsAg levels.

    Time frame: Up to 60 weeks

  6. For participants with HBsAg levels more than100 IU/mL at baseline: Proportion of participants with HBsAg levels ≤ 10 IU/mL at end of trial (Week 60).

    Proportion of refers to the percentage or fraction of participants in the trial who meet the specified criteria.

    Time frame: 60 weeks

  7. Proportion of participants with undetectable HDV RNA (i.e., less than the limit of detection), or ≥ 2 log10 decrease in HDV RNA and alanine transaminase (ALT) normalisation, at end of trial (Week 60).

    Proportion of refers to the percentage or fraction of participants in the trial who meet the specified criteria.

    Time frame: 60 weeks

  8. Proportion of participants with undetectable HDV RNA (i.e., less than the limit of detection) or ≥ 2 log10 decrease in HDV RNA at end of trial (Week 60).

    Proportion of refers to the percentage or fraction of participants in the trial who meet the specified criteria.

    Time frame: 60 weeks

  9. Plasma concentrations of RBD1016.

    Time frame: 60 weeks

Other outcomes

  1. Frequency, intensity and seriousness of reported AEs, SAEs and AEs of special interest

    Number and percentage of participants with reported AEs, SAEs and AEs of special interest. All reported AE terms will be coded using Medical Dictionary for Drug Regulatory Affairs (MedDRA).

    Time frame: Week 60 to week 108

  2. Dynamic changes based on local lab measurements, of HDV RNA, HBsAg, HBsAb-status and HBV DNA levels

    Dynamic changes based on local lab measurements, of HDV RNA, HBsAg, HBsAb-status and HBV DNA levels

    Time frame: at each evaluation time point of the extension part of the trial up to end of trial extension (Week 108

  3. Proportion of participants with undetectable HDV RNA (i.e, < limit of detection based on local lab measurement)

    Proportion of participants with undetectable HDV RNA (i.e, \< limit of detection based on local lab measurement)

    Time frame: at any evaluation time point of the extension part of the trial.

06

Study locations

2 sites
  • Medicinsk enhet för Infektionssjukdomar, Karolinska Universitetssjukhuset Huddinge
    Stockholm, 14186, Sweden
  • Infektionskliniken, Danderyds sjukhus
    Stockholm, 18288, Sweden
07

References and documents

Individual participant data

Plan to share: Undecided — Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06649266
Lead sponsor
Ribocure Pharmaceuticals AB
Responsible party
Sponsor
First posted
Oct 18, 2024
Start date
Aug 21, 2024
Primary completion
Sep 2026 (estimated)
Completion
Aug 2027 (estimated)
Last update
Feb 3, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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