Hepatitis B, ChronicPhase 1NCT03772249
Study of Safety and Tolerability of DCR HBVS
A Phase 1 study testing DCR-HBVS in people with Hepatitis B, Chronic, run by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company at 9 sites in 5 countries.
Trial summary
DCR-HBVS will be evaluated for safety and efficacy in healthy volunteers and chronic hepatitis B patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- DCR-HBVS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 28 Dec 2018to 12 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy at the time of screening as determined by medical evaluation.
- Capable of giving informed consent.
- 12-lead ECG within normal limits or with no clinically significant abnormalities.
- Negative screen for alcohol or drugs of abuse.
- Non-smokers for at least 3 months with a negative urinary cotinine concentration at screening.
- BMI within range 18.0 - 32.0 kg/m2 (inclusive).
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- Female participants not pregnant, not breastfeeding, and not of childbearing potential or willing to follow contraceptive guidance.
- Chronic hepatitis B infection (Group B and C only).
- Clinical history compatible with compensated liver disease with no evidence of cirrhosis (Group B and C only).
- Continuously on nucleotides (NUC) therapy for at least 12 weeks prior to screening (Group C only).
Who cannot join
- History of any medical condition that may interfere with the absorption, distribution, or elimination of study drug.
- Poorly controlled or unstable hypertension.
- History of diabetes mellitus treated with insulin or hypoglycemic agents.
- History of asthma requiring hospital admission within the preceding 12 months.
- Evidence of G-6-PD deficiency.
- Currently poorly controlled endocrine conditions, excluding thyroid conditions.
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- History of multiple drug allergies or history of allergic reaction to an oligonucleotide or GalNAc.
- Clinically relevant surgical history.
- Use of prescription medications (excluding contraception for women) within 4 weeks prior to the administration of study intervention.
- Use of clinically relevant over-the-counter medication or supplements (excluding routine vitamins) within 7 days of first dosing.
- Has received an investigational agent within the 3 months prior to dosing or is in follow-up of another study.
- Antiviral therapy (other than entecavir or tenofovir) within 3 months of screening or treatment with interferon in the last 3 years (Group B and C only).
- Use within the last 6 months of anticoagulants or systemically administered corticosteroids, immunomodulators, or immunosuppressants (Group B and C only).
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Australia2 sites
Monash Health
Clayton, Victoria, 3168
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
New Zealand2 sites
Clinical Site
Auckland, 1023
Middlemore Hospital
Auckland
South Korea2 sites
Seoul National University Hospital
Seoul
Seoul Metropolitan Government - Seoul National University Boramae Medical Center
Soeul
Thailand2 sites
King Culalongkorn Memorial Hospital
Bangkok
Srinagarind Hospital
Khon Kaen
About this study
Official title: A Three-Part, Phase 1, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of DCR-HBVS in Healthy Volunteers and Patients With Chronic Hepatitis B
DCR-HBVS will be evaluated for safety and efficacy in healthy volunteers and chronic hepatitis B patients.
Read the detailed description
DCR HBVS is being developed for the treatment of chronic hepatitis B (CHB) in adults. The study will be conducted in 3 parts, a single ascending-dose (SAD) phase in normal healthy volunteers (Group A), a single-dose (SD) phase in patients with CHB (Group B), and a multiple ascending-dose (MAD) phase in patients with CHB (Group 1c-3c). Cohort 4c is a single ascending dose with a possible duration of up to 48 weeks. Cohort 5c is a multiple dose cohort with a possible duration of up to 72 weeks.
- Conditions
- Hepatitis B, Chronic
- Being tested
- DCR-HBVS, Placebo for DCR-HBVS
- Keywords
- Chronic Hepatitis B, DNA Virus Infections, CHB, HBsAg, Liver Disease, RNAi
- Medical subject headings
- Hepatitis B, Chronic, DNA Virus Infections, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCR-HBVSDrug
Also called DCR-S219
DCR-HBVS is a synthetic ribonucleic acid interference (RNAi) drug that consists of a double-stranded oligonucleotide conjugated to N-acetyl-D-galactosamine (GalNAc) ligands. DCR-HBVS is a sterile solution of the siRNA (DCR-S219) at a concentration of 195 mg/mL in water for injection (WFI).
Placebo for DCR-HBVSDrug
Also called Placebo
Sterile 9% saline for injection.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1 DCR-HBVS | Experimental | Single dose, Subcutaneous injection of 0.1mg/kg of DCR-HBVS (HV) Receives: Drug: DCR-HBVS |
| Cohort A1 Placebo | Placebo comparator | Single dose, Subcutaneous injection of 0.1mg/kg of Placebo for DCR-HBVS (HV) Receives: Drug: Placebo for DCR-HBVS |
| Cohort A2 DCR-HBVS | Experimental | Single dose, Subcutaneous injection of 1.5mg/kg of DCR-HBVS (HV) Receives: Drug: DCR-HBVS |
| Cohort A2 Placebo | Placebo comparator | Single dose, Subcutaneous injection of 1.5mg/kg of Placebo for DCR-HBVS (HV) Receives: Drug: Placebo for DCR-HBVS |
| Cohort A3 DCR-HBVS | Experimental | Single dose, Subcutaneous injection of 3mg/kg of DCR-HBVS (HV) Receives: Drug: DCR-HBVS |
| Cohort A3 Placebo | Placebo comparator | Single dose, Subcutaneous injection of 3mg/kg of Placebo for DCR-HBVS (HV) Receives: Drug: Placebo for DCR-HBVS |
| Cohort A4 DCR-HBVS | Experimental | Single dose, Subcutaneous injection of 6mg/kg of DCR-HBVS (HV) Receives: Drug: DCR-HBVS |
| Cohort A4 Placebo | Placebo comparator | Single dose, Subcutaneous injection of 6mg/kg of Placebo for DCR-HBVS (HV) Receives: Drug: Placebo for DCR-HBVS |
| Cohort A5 DCR-HBVS | Experimental | Single dose, Subcutaneous injection of 12mg/kg of DCR-HBVS (HV) Receives: Drug: DCR-HBVS |
| Cohort A5 Placebo | Placebo comparator | Single dose, Subcutaneous injection of 12mg/kg of Placebo for DCR-HBVS (HV) Receives: Drug: Placebo for DCR-HBVS |
| Cohort B DCR-HBVS | Experimental | Single dose, Subcutaneous injection of 3mg/kg of for DCR-HBVS (NUC naïve, CHB) Receives: Drug: DCR-HBVS |
| Cohort B Placebo | Placebo comparator | Single dose, Subcutaneous injection of 3mg/kg of Placebo for DCR-HBVS (NUC naïve, CHB) Receives: Drug: Placebo for DCR-HBVS |
| Cohort C1 DCR-HBVS | Experimental | 4 doses- Subcutaneous injection of 1.5mg/kg of DCR-HBVS administered every 28 days (NUC experienced, CHB) Receives: Drug: DCR-HBVS |
| Cohort C1 Placebo | Placebo comparator | 4 doses- Subcutaneous injection of 1.5mg/kg of Placebo for DCR-HBVS administered every 28 days (NUC experienced, CHB) Receives: Drug: Placebo for DCR-HBVS |
| Cohort C2 DCR-HBVS | Experimental | 4 doses- Subcutaneous injection of 3mg/kg of DCR-HBVS administered every 28 days (NUC experienced, CHB) Receives: Drug: DCR-HBVS |
| Cohort C2 Placebo | Placebo comparator | 4 doses- Subcutaneous injection of 3mg/kg of Placebo for DCR-HBVS administered every 28 days (NUC experienced, CHB) Receives: Drug: Placebo for DCR-HBVS |
| Cohort C3 DCR-HBVS | Experimental | 4 doses- Subcutaneous injection of 6mg/kg of DCR-HBVS administered every 28 days (NUC experienced, CHB) Receives: Drug: DCR-HBVS |
| Cohort C3 Placebo | Placebo comparator | 4 doses- Subcutaneous injection of 6mg/kg of Placebo for DCR-HBVS administered every 28 days (NUC experienced, CHB) Receives: Drug: Placebo for DCR-HBVS |
| Cohort 4C DCR-HBVS | Experimental | 1 dose- Subcutaneous injection of 100mg (NUC experienced, CHB)
1 dose- Subcutaneous injection of 200mg (NUC experienced, CHB)
1 dose- Subcutaneous injection of 400mg (NUC experienced, CHB) Receives: Drug: DCR-HBVS |
| Cohort 5C1 DCR-HBVS | Experimental | 4 doses- Subcutaneous injection of 200mg administered every 4 weeks (NUC experienced, CHB) Receives: Drug: DCR-HBVS |
| Cohort 5C2 DCR-HBVS | Experimental | 2 doses- Subcutaneous injection of 200mg administered every 8 weeks (NUC experienced, CHB) Receives: Drug: DCR-HBVS |
| Cohort 5C3 DCR-HBVS | Experimental | 2 doses- Subcutaneous injection of 400mg administered every 12 weeks (NUC experienced, CHB) Receives: Drug: DCR-HBVS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of healthy volunteers with Adverse Events as assessed by CTCAE v5.0
Number of participants with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings
Measured: 4 weeks
Number participants with non-cirrhotic chronic Hepatitis B with Adverse Events as assessed by CTCAE v5.0
Number of participants with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings
Measured: 16 weeks
Secondary outcomes (4)
To characterize the pharmacokinetics of DCR-HBVS in healthy volunteers by monitoring plasma pharmacokinetics profiles of DCR-S219
Measure the amount of DCR-HBVS excreted in urine
Measured: 4 weeks
To characterize the pharmacokinetics of DCR-HBVS in healthy volunteers by monitoring through concentrations of DCR-S219
Measure the amount of DCR-HBVS renal clearance (CLR).
Measured: 4 weeks
To characterize the pharmacokinetics of DCR-HBVS in participants with non-cirrhotic CHB by monitoring plasma pharmacokinetics profiles of DCR-HBVS.
Measure the amount of DCR-HBVS excreted in urine
Measured: 12 weeks
To characterize the pharmacokinetics of DCR-HBVS in participants with non-cirrhotic CHB by monitoring through concentrations of DCR-HBVS.
Measure DCR-HBVS renal clearance (CLR).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start28 Dec 2018
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B, ChronicStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Progression from the SAD phase to the first cohort in the MAD phase is contingent upon the Safety Review Committee (SRC) review of a minimum of 14 days post-dose safety and tolerability data from all NHV in at least the first 2 SAD cohorts. The SRC will select one (or more) well-tolerated dose(s) from the SAD phase for administration in the SD and MAD phases. Group B at 3 mg/kg will start in parallel with Group C at the 3 mg/kg dose level. In all study phases, dosing will be staggered with the use of sentinel participants to allow time for the assessment of safety before additional subjects are exposed to study drug. The fixed dosing regimen for Cohorts 4c and 5c was determined following SRC review and assessment of all data up to Cohort 3c. No sentinel dosing will occur in Cohorts 4c and 5c.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Bowman, MD, Study director, Dicerna Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772249
- Sponsor's protocol ID
- DCR-HBVS-101
- Other IDs
- U1111-1220-7021
- Status last verified
- Sep 2024
- First submitted
- 3 Dec 2018
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Gane EJ, Kim W, Lim TH, Tangkijvanich P, Yoon JH, Sievert W, Sukeepaisarnjaroen W, Thompson AJ, Pavlovic V, Surujbally B, Wat C, Brown BD, Achneck HE, Yuen MF. First-in-human randomized study of RNAi therapeutic RG6346 for chronic hepatitis B virus infection. J Hepatol. 2023 Nov;79(5):1139-1149. doi: 10.1016/j.jhep.2023.07.026. Epub 2023 Jul 29.
PubMed 37524230
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Part, Phase 1, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of DCR-HBVS in Healthy Volunteers and Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT03772249
- Acronym / sponsor ID
- DCR-HBVS-101
- Conditions
- Hepatitis B, Chronic
- Keywords
- Chronic Hepatitis B, DNA Virus Infections, CHB, HBsAg, Liver Disease, RNAi
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk companyIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2018 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 11 Dec 2018 (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.
DCR-HBVS will be evaluated for safety and efficacy in healthy volunteers and chronic hepatitis B patients.
Detailed description
DCR HBVS is being developed for the treatment of chronic hepatitis B (CHB) in adults. The study will be conducted in 3 parts, a single ascending-dose (SAD) phase in normal healthy volunteers (Group A), a single-dose (SD) phase in patients with CHB (Group B), and a multiple ascending-dose (MAD) phase in patients with CHB (Group 1c-3c). Cohort 4c is a single ascending dose with a possible duration of up to 48 weeks. Cohort 5c is a multiple dose cohort with a possible duration of up to 72 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 22
- Model description
- Progression from the SAD phase to the first cohort in the MAD phase is contingent upon the Safety Review Committee (SRC) review of a minimum of 14 days post-dose safety and tolerability data from all NHV in at least the first 2 SAD cohorts. The SRC will select one (or more) well-tolerated dose(s) from the SAD phase for administration in the SD and MAD phases. Group B at 3 mg/kg will start in parallel with Group C at the 3 mg/kg dose level. In all study phases, dosing will be staggered with the use of sentinel participants to allow time for the assessment of safety before additional subjects are exposed to study drug. The fixed dosing regimen for Cohorts 4c and 5c was determined following SRC review and assessment of all data up to Cohort 3c. No sentinel dosing will occur in Cohorts 4c and 5c.
| Arm | Type | Receives |
|---|---|---|
| Cohort A1 DCR-HBVS | Experimental | Drug: DCR-HBVSSingle dose, Subcutaneous injection of 0.1mg/kg of DCR-HBVS (HV) |
| Cohort A1 Placebo | Placebo comparator | Drug: Placebo for DCR-HBVSSingle dose, Subcutaneous injection of 0.1mg/kg of Placebo for DCR-HBVS (HV) |
| Cohort A2 DCR-HBVS | Experimental | Drug: DCR-HBVSSingle dose, Subcutaneous injection of 1.5mg/kg of DCR-HBVS (HV) |
| Cohort A2 Placebo | Placebo comparator | Drug: Placebo for DCR-HBVSSingle dose, Subcutaneous injection of 1.5mg/kg of Placebo for DCR-HBVS (HV) |
| Cohort A3 DCR-HBVS | Experimental | Drug: DCR-HBVSSingle dose, Subcutaneous injection of 3mg/kg of DCR-HBVS (HV) |
| Cohort A3 Placebo | Placebo comparator | Drug: Placebo for DCR-HBVSSingle dose, Subcutaneous injection of 3mg/kg of Placebo for DCR-HBVS (HV) |
| Cohort A4 DCR-HBVS | Experimental | Drug: DCR-HBVSSingle dose, Subcutaneous injection of 6mg/kg of DCR-HBVS (HV) |
| Cohort A4 Placebo | Placebo comparator | Drug: Placebo for DCR-HBVSSingle dose, Subcutaneous injection of 6mg/kg of Placebo for DCR-HBVS (HV) |
| Cohort A5 DCR-HBVS | Experimental | Drug: DCR-HBVSSingle dose, Subcutaneous injection of 12mg/kg of DCR-HBVS (HV) |
| Cohort A5 Placebo | Placebo comparator | Drug: Placebo for DCR-HBVSSingle dose, Subcutaneous injection of 12mg/kg of Placebo for DCR-HBVS (HV) |
| Cohort B DCR-HBVS | Experimental | Drug: DCR-HBVSSingle dose, Subcutaneous injection of 3mg/kg of for DCR-HBVS (NUC naïve, CHB) |
| Cohort B Placebo | Placebo comparator | Drug: Placebo for DCR-HBVSSingle dose, Subcutaneous injection of 3mg/kg of Placebo for DCR-HBVS (NUC naïve, CHB) |
| Cohort C1 DCR-HBVS | Experimental | Drug: DCR-HBVS4 doses- Subcutaneous injection of 1.5mg/kg of DCR-HBVS administered every 28 days (NUC experienced, CHB) |
| Cohort C1 Placebo | Placebo comparator | Drug: Placebo for DCR-HBVS4 doses- Subcutaneous injection of 1.5mg/kg of Placebo for DCR-HBVS administered every 28 days (NUC experienced, CHB) |
| Cohort C2 DCR-HBVS | Experimental | Drug: DCR-HBVS4 doses- Subcutaneous injection of 3mg/kg of DCR-HBVS administered every 28 days (NUC experienced, CHB) |
| Cohort C2 Placebo | Placebo comparator | Drug: Placebo for DCR-HBVS4 doses- Subcutaneous injection of 3mg/kg of Placebo for DCR-HBVS administered every 28 days (NUC experienced, CHB) |
| Cohort C3 DCR-HBVS | Experimental | Drug: DCR-HBVS4 doses- Subcutaneous injection of 6mg/kg of DCR-HBVS administered every 28 days (NUC experienced, CHB) |
| Cohort C3 Placebo | Placebo comparator | Drug: Placebo for DCR-HBVS4 doses- Subcutaneous injection of 6mg/kg of Placebo for DCR-HBVS administered every 28 days (NUC experienced, CHB) |
| Cohort 4C DCR-HBVS | Experimental | Drug: DCR-HBVS1 dose- Subcutaneous injection of 100mg (NUC experienced, CHB) 1 dose- Subcutaneous injection of 200mg (NUC experienced, CHB) 1 dose- Subcutaneous injection of 400mg (NUC experienced, CHB) |
| Cohort 5C1 DCR-HBVS | Experimental | Drug: DCR-HBVS4 doses- Subcutaneous injection of 200mg administered every 4 weeks (NUC experienced, CHB) |
| Cohort 5C2 DCR-HBVS | Experimental | Drug: DCR-HBVS2 doses- Subcutaneous injection of 200mg administered every 8 weeks (NUC experienced, CHB) |
| Cohort 5C3 DCR-HBVS | Experimental | Drug: DCR-HBVS2 doses- Subcutaneous injection of 400mg administered every 12 weeks (NUC experienced, CHB) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy at the time of screening as determined by medical evaluation.
- Capable of giving informed consent.
- 12-lead ECG within normal limits or with no clinically significant abnormalities.
- Negative screen for alcohol or drugs of abuse.
- Non-smokers for at least 3 months with a negative urinary cotinine concentration at screening.
Key exclusion criteria (13 listed)
- History of any medical condition that may interfere with the absorption, distribution, or elimination of study drug.
- Poorly controlled or unstable hypertension.
- History of diabetes mellitus treated with insulin or hypoglycemic agents.
- History of asthma requiring hospital admission within the preceding 12 months.
- Evidence of G-6-PD deficiency.
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 |
|---|---|---|
| DCR-HBVSAlso: DCR-S219DCR-HBVS is a synthetic ribonucleic acid interference (RNAi) drug that consists of a double-stranded oligonucleotide conjugated to N-acetyl-D-galactosamine (GalNAc) ligands. DCR-HBVS is a sterile solution of the siRNA (DCR-S219) at a concentration of 195 mg/mL in water for injection (WFI). | Drug | Cohort 4C DCR-HBVS, Cohort 5C1 DCR-HBVS, Cohort 5C2 DCR-HBVS, Cohort 5C3 DCR-HBVS, Cohort A1 DCR-HBVS, Cohort A2 DCR-HBVS, Cohort A3 DCR-HBVS, Cohort A4 DCR-HBVS, Cohort A5 DCR-HBVS, Cohort B DCR-HBVS, Cohort C1 DCR-HBVS, Cohort C2 DCR-HBVS, Cohort C3 DCR-HBVS |
| Placebo for DCR-HBVSAlso: PlaceboSterile 9% saline for injection. | Drug | Cohort A1 Placebo, Cohort A2 Placebo, Cohort A3 Placebo, Cohort A4 Placebo, Cohort A5 Placebo, Cohort B Placebo, Cohort C1 Placebo, Cohort C2 Placebo, Cohort C3 Placebo |
Primary outcome
Number of healthy volunteers with Adverse Events as assessed by CTCAE v5.0
Time frame: 4 weeks
Number of participants with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings
Number participants with non-cirrhotic chronic Hepatitis B with Adverse Events as assessed by CTCAE v5.0
Time frame: 16 weeks
Number of participants with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings
4 secondary outcomes
To characterize the pharmacokinetics of DCR-HBVS in healthy volunteers by monitoring plasma pharmacokinetics profiles of DCR-S219
Time frame: 4 weeks
To characterize the pharmacokinetics of DCR-HBVS in healthy volunteers by monitoring through concentrations of DCR-S219
Time frame: 4 weeks
To characterize the pharmacokinetics of DCR-HBVS in participants with non-cirrhotic CHB by monitoring plasma pharmacokinetics profiles of DCR-HBVS.
Time frame: 12 weeks
To characterize the pharmacokinetics of DCR-HBVS in participants with non-cirrhotic CHB by monitoring through concentrations of DCR-HBVS.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 37524230Gane EJ, Kim W, Lim TH, Tangkijvanich P, Yoon JH, Sievert W, Sukeepaisarnjaroen W, Thompson AJ, Pavlovic V, Surujbally B, Wat C, Brown BD, Achneck HE, Yuen MF. First-in-human randomized study of RNAi therapeutic RG6346 for chronic hepatitis B virus infection. J Hepatol. 2023 Nov;79(5):1139-1149. doi: 10.1016/j.jhep.2023.07.026. Epub 2023 Jul 29.
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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.
Thomas Bowman, MD study director
Dicerna Pharmaceuticals
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DCR-HBVS in people with Hepatitis B, Chronic, run by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company at 9 sites in 5 countries.
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 10 inclusion and 13 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Australia, New Zealand, South Korea, Thailand, Hong Kong. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of healthy volunteers with Adverse Events as assessed by CTCAE v5.0 (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03772249, which also lists 1 linked publication.
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 19 Sep 2024.