Chronic Hepatitis DPhase 2NCT06649266
Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of RBD1016 in Participants With Chronic Hepatitis D
A Phase 2 study testing RBD1016 in people with Chronic Hepatitis D, run by Ribocure Pharmaceuticals AB at 2 sites in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis D
- What is being tested?
- RBD1016
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 2 sitesSweden
- Study dates
- 21 Aug 2024to Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Creatinine concentration \> 1.5 × ULN.
- Creatinine clearance \< 60 mL/min, according to the Cockcroft-Gault equation.
- 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.
- 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.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Medicinsk enhet för Infektionssjukdomar, Karolinska Universitetssjukhuset Huddinge
Stockholm, 14186
Infektionskliniken, Danderyds sjukhus
Stockholm, 18288
About this study
Official title: 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
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.
- Conditions
- Chronic Hepatitis D
- Being tested
- RBD1016, Placebo
- Medical subject headings
- Hepatitis D, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBD1016Drug
RBD1016, active drug.
PlaceboDrug
Placebo that is identical in appearance and volume to the doses of active IMP.
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | Participants will receive RBD1016 (subcutaneous injections). Receives: Drug: RBD1016 |
| Deferred active group | Other | Participants will receive 4 doses of placebo (subcutaneous injections) followed by RBD1016 (subcutaneous injections). Receives: Drug: RBD1016; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change (log10 value) vs. baseline in HDV RNA levels in plasma at end of trial (Week 60).
Measured: 60 weeks
Secondary outcomes (9)
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).
Measured: 60 weeks
Mean change (log10 value) in HBsAg levels vs. baseline, at end of trial (Week 60).
Measured: 60 weeks
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.
Measured: 60 weeks
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.
Measured: Up to 60 weeks
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.
Measured: Up to 60 weeks
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.
Measured: 60 weeks
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.
Measured: 60 weeks
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.
Measured: 60 weeks
Plasma concentrations of RBD1016.
Measured: 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start21 Aug 2024
- Primary completion24 Sep 2026
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Partly blinded, placebo-controlled clinical trial with an active and a deferred active group.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ribocure Pharmaceuticals AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649266
- Sponsor's protocol ID
- RC04T001
- Status last verified
- Oct 2026
- First submitted
- 18 Sep 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06649266
- Acronym / sponsor ID
- RC04T001
- Conditions
- Chronic Hepatitis D
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ribocure Pharmaceuticals ABIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 24 Sep 2026 (actual)
- Study completion
- Aug 2027 (estimated)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Partly blinded, placebo-controlled clinical trial with an active and a deferred active group.
| Arm | Type | Receives |
|---|---|---|
| Active group | Experimental | Drug: RBD1016Participants will receive RBD1016 (subcutaneous injections). |
| Deferred active group | Other | Drug: RBD1016, Drug: PlaceboParticipants will receive 4 doses of placebo (subcutaneous injections) followed by RBD1016 (subcutaneous injections). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RBD1016RBD1016, active drug. | Drug | Active group, Deferred active group |
| PlaceboPlacebo that is identical in appearance and volume to the doses of active IMP. | Drug | Deferred active group |
Primary outcome
Mean change (log10 value) vs. baseline in HDV RNA levels in plasma at end of trial (Week 60).
Time frame: 60 weeks
9 secondary outcomes
Frequency, intensity and seriousness of reported AEs, SAEs and AEs of special interest (AESIs) during the trial.
Time frame: 60 weeks
Mean change (log10 value) in HBsAg levels vs. baseline, at end of trial (Week 60).
Time frame: 60 weeks
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
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.
Time frame: Up to 60 weeks
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.
Time frame: Up to 60 weeks
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).
Time frame: 60 weeks
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).
Time frame: 60 weeks
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).
Time frame: 60 weeks
Plasma concentrations of RBD1016.
Time frame: 60 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RBD1016 in people with Chronic Hepatitis D, run by Ribocure Pharmaceuticals AB at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change (log10 value) vs. baseline in HDV RNA levels in plasma at end of trial (Week 60). (time frame: 60 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.