Chronic Hepatitis BPhase 1NCT04629976
Activity of NCO-48 Fumarate in Treatment-Naive Adults With Chronic Hepatitis B
A Phase 1 study testing NCO-48 Fumarate 4 mg, NCO-48 Fumarate 20 mg and Tenofovir Alafenamide 25 mg in people with Chronic Hepatitis B, run by Nucorion Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This is an open-label study evaluating multiple doses of NCO-48 Fumarate versus tenofovir alafenamide (TAF). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- NCO-48 Fumarate 4 mg, NCO-48 Fumarate 20 mg and Tenofovir Alafenamide 25 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2021to 28 Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and female subjects between 18 and 65 years of age
- Female subjects of non-childbearing potential must be surgically sterile or postmenopausal at the Screening Visit
- Female subjects of childbearing potential who are sexually active with a non-sterile male partner must be using a medically acceptable form of birth control for the duration of the study and for 30 days after the last dose of study drug and must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test upon admission to the study site
- HBV treatment-naive or treatment-experienced with (pegylated or non pegylated) interferon alpha (must have ended at least 6 months prior to the Screening Visit)
- Screening plasma HBV DNA ≥ 2x10^3 IU/mL
- Positive for serum hepatitis B surface antigen for more than 6 months
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- Estimated creatinine clearance (CLCr) ≥ 70 mL/min
- Serum transaminase activity (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT] levels) <10 x the upper limit of normal
- Compensated liver disease with normal prothrombin time/international normalized ratio, hematology, albumin, bilirubin (unless subject has Gilbert's disease). Serum AST and/or ALT levels may be normal or elevated
- Body mass index within the range of 18.5 to 35 kg/m2, inclusive, and body weight >45 kg
- Normal vital signs, without any clinically significant abnormalities at the Screening Visit
- Subjects who have normal or abnormal clinically insignificant clinical laboratory assessments as considered by the Investigator from pre-treatment blood tests to assess hematology, liver (except for serum AST and/or ALT levels) and renal biochemistry, urinalysis, and drug screen
- Normal 12-lead electrocardiogram (ECG), with no clinically significant abnormalities of rate, rhythm, or conduction and including normal heart rate-corrected QT interval segment time at the Screening Visit
Who cannot join
- Received treatment with TFV disoproxil fumarate or TAF (including clinical study experience)
- Positive for hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
- History or presence of asthma or other pulmonary disease, thyroid disease, or other liver disease
- Hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of study drug, or would place the subject at increased risk
- Abnormal laboratory values that are considered clinically significant
- Have used medication, other than topical products without significant systemic absorption, hormonal contraceptives, or hormone replacement therapy and thyroid medication for at least 6 months
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- Unwilling to refrain from consumption of alcohol within 48 hours prior to each dose of study drug and during the inpatient period, or have a history of significant alcohol abuse within 1 year prior to Screening
- Positive urine drug screen, or positive alcohol breath test at Screening or upon admission to the study site
- Use of illicit drugs within 3 months prior to the Screening Visit or hard drugs within 1 year prior to the Screening Visit, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction
- Women who are breastfeeding or have a positive pregnancy test at the Screening Visit or at any time during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Clinical Research, Inc
Monterey Park, California, 91754
About this study
Official title: Randomized, Open-Label, Active Comparator, Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Hepatitis B Virus (HBV) Activity of NCO-48 Fumarate in Treatment-Naive Adults With Chronic HBV Infection
This is an open-label study evaluating multiple doses of NCO-48 Fumarate versus tenofovir alafenamide (TAF).
Read the detailed description
This is a randomized, open-label, active comparator, multiple oral dose study to evaluate the safety, tolerability, pharmacokinetics, and anti-hepatitis B virus (HBV) activity of NCO-48 Fumarate in treatment-naive adults with chronic HBV infection. This study will evaluate the safety, viral kinetics, and antiviral activity of 2 different doses of NCO-48 Fumarate over 28 days of therapy. In addition, the study will evaluate the antiviral activity of an optimal dose of NCO-48 Fumarate versus 25 mg tenofovir alafenamide (TAF) over 28 days of therapy.
- Conditions
- Chronic Hepatitis B
- Being tested
- NCO-48 Fumarate 4 mg, NCO-48 Fumarate 20 mg, Tenofovir Alafenamide 25 mg
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCO-48 Fumarate 4 mgDrug
2 x 2mg NCO-48 Fumarate over 28 days of therapy
NCO-48 Fumarate 20 mgDrug
2 x 10 mg NCO-48 Fumarate over 28 days of therapy
Tenofovir Alafenamide 25 mgDrug
Also called Vemlidy ®
25 mg over 28 days of therapy
| Study group | Role | What they receive |
|---|---|---|
| NCO-48 Fumarate 4 mg | Experimental | Eligible subjects will be randomized 1:1:1 to receive either open-label NCO-48 Fumarate 4 mg or 20 mg, or open-label TAF 25 mg for 28 days. Receives: Drug: NCO-48 Fumarate 4 mg |
| NCO-48 Fumarate 20 mg | Experimental | Eligible subjects will be randomized 1:1:1 to receive either open-label NCO-48 Fumarate 4 mg or 20 mg, or open-label TAF 25 mg for 28 days. Receives: Drug: NCO-48 Fumarate 20 mg |
| Tenofovir alafenamide 25 mg | Active comparator | Eligible subjects will be randomized 1:1:1 to receive either open-label NCO-48 Fumarate 4 mg or 20 mg, or open-label TAF 25 mg for 28 days. Receives: Drug: Tenofovir Alafenamide 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hepatitis B virus (HBV) DNA
Time-weighted average change from baseline through Week 4 in plasma HBV DNA (log10 IU/mL) for NCO-48 Fumarate 4 and 20-mg.
Measured: Up to Week 4
Secondary outcomes (6)
Change in HBV DNA for tenofovir alafenamide (TAF)
Comparing the short-term antiviral activity of NCO-48 Fumarate with TAF 25 mg. This is measured by time-weighted average change from baseline through Week 4 in plasma HBV DNA (log10 IU/mL) for TAF.
Measured: Up to Week 4
Incidence of Treatment-Emergent Adverse Events
Safety and tolerability is measured by the incidence of treatment-emergent adverse events.
Measured: Up to week 4
NCO-48 Fumarate Area Under the Concentration -Time Curve (AUC)
Blood samples are to be collected at designated time points for the determination of the NCO-48 Fumarate AUC.
Measured: Up to week 4
NCO-48 Fumarate Maximum Plasma Concentration (Cmax)
Blood samples are to be collected at designated time points for the determination of the NCO-48 Fumarate Cmax.
Measured: Up to week 4
Tenofovir (TFV) Area under the Concentration-Time Curve (AUC)
Blood samples are to be collected at designated time points for the determination of TFV AUC.
Measured: Up to week 4
TFV Maximum Plasma Concentration (Cmax)
Blood samples are to be collected at designated time points for the determination of TFV Cmax.
Measured: Up to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start12 Jan 2021
- Primary completion30 Sep 2022
- Study completion28 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies 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
- Parallel groups
- Model description
- After Screening procedures, eligible subjects will be randomized 1:1:1 to receive either open-label NCO-48 Fumarate 4 mg (2 x 2 mg) or 20 mg (2 x 10 mg), or open-label TAF 25 mg for 28 days.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nucorion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ligand Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Keith Marschke, Study director, Ligand Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629976
- Sponsor's protocol ID
- NCO48F-02
- Status last verified
- Jan 2023
- First submitted
- 4 Nov 2020
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-Label, Active Comparator, Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Hepatitis B Virus (HBV) Activity of NCO-48 Fumarate in Treatment-Naive Adults With Chronic HBV Infection
- ClinicalTrials.gov ID
- NCT04629976
- Acronym / sponsor ID
- NCO48F-02
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Nucorion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Ligand Pharmaceuticals
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 16 Nov 2020 (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.
This is an open-label study evaluating multiple doses of NCO-48 Fumarate versus tenofovir alafenamide (TAF).
Detailed description
This is a randomized, open-label, active comparator, multiple oral dose study to evaluate the safety, tolerability, pharmacokinetics, and anti-hepatitis B virus (HBV) activity of NCO-48 Fumarate in treatment-naive adults with chronic HBV infection. This study will evaluate the safety, viral kinetics, and antiviral activity of 2 different doses of NCO-48 Fumarate over 28 days of therapy. In addition, the study will evaluate the antiviral activity of an optimal dose of NCO-48 Fumarate versus 25 mg tenofovir alafenamide (TAF) over 28 days of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- After Screening procedures, eligible subjects will be randomized 1:1:1 to receive either open-label NCO-48 Fumarate 4 mg (2 x 2 mg) or 20 mg (2 x 10 mg), or open-label TAF 25 mg for 28 days.
| Arm | Type | Receives |
|---|---|---|
| NCO-48 Fumarate 4 mg | Experimental | Drug: NCO-48 Fumarate 4 mgEligible subjects will be randomized 1:1:1 to receive either open-label NCO-48 Fumarate 4 mg or 20 mg, or open-label TAF 25 mg for 28 days. |
| NCO-48 Fumarate 20 mg | Experimental | Drug: NCO-48 Fumarate 20 mgEligible subjects will be randomized 1:1:1 to receive either open-label NCO-48 Fumarate 4 mg or 20 mg, or open-label TAF 25 mg for 28 days. |
| Tenofovir alafenamide 25 mg | Active comparator | Drug: Tenofovir Alafenamide 25 mgEligible subjects will be randomized 1:1:1 to receive either open-label NCO-48 Fumarate 4 mg or 20 mg, or open-label TAF 25 mg for 28 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adult male and female subjects between 18 and 65 years of age
- Female subjects of non-childbearing potential must be surgically sterile or postmenopausal at the Screening Visit
- Female subjects of childbearing potential who are sexually active with a non-sterile male partner must be using a medically acceptable form of birth control for the duration of the study and for 30 days after the last dose of study drug and must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test upon admission to the study site
- HBV treatment-naive or treatment-experienced with (pegylated or non pegylated) interferon alpha (must have ended at least 6 months prior to the Screening Visit)
- Screening plasma HBV DNA ≥ 2x10^3 IU/mL
Key exclusion criteria (10 listed)
- Received treatment with TFV disoproxil fumarate or TAF (including clinical study experience)
- Positive for hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
- History or presence of asthma or other pulmonary disease, thyroid disease, or other liver disease
- Hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of study drug, or would place the subject at increased risk
- Abnormal laboratory values that are considered clinically significant
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 |
|---|---|---|
| NCO-48 Fumarate 4 mg2 x 2mg NCO-48 Fumarate over 28 days of therapy | Drug | NCO-48 Fumarate 4 mg |
| NCO-48 Fumarate 20 mg2 x 10 mg NCO-48 Fumarate over 28 days of therapy | Drug | NCO-48 Fumarate 20 mg |
| Tenofovir Alafenamide 25 mgAlso: Vemlidy ®25 mg over 28 days of therapy | Drug | Tenofovir alafenamide 25 mg |
Primary outcome
Change in hepatitis B virus (HBV) DNA
Time frame: Up to Week 4
Time-weighted average change from baseline through Week 4 in plasma HBV DNA (log10 IU/mL) for NCO-48 Fumarate 4 and 20-mg.
6 secondary outcomes
Change in HBV DNA for tenofovir alafenamide (TAF)
Time frame: Up to Week 4
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to week 4
NCO-48 Fumarate Area Under the Concentration -Time Curve (AUC)
Time frame: Up to week 4
NCO-48 Fumarate Maximum Plasma Concentration (Cmax)
Time frame: Up to week 4
Tenofovir (TFV) Area under the Concentration-Time Curve (AUC)
Time frame: Up to week 4
TFV Maximum Plasma Concentration (Cmax)
Time frame: Up to week 4
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 4 Jan 2023.
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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.
Keith Marschke study director
Ligand Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NCO-48 Fumarate 4 mg, NCO-48 Fumarate 20 mg and Tenofovir Alafenamide 25 mg in people with Chronic Hepatitis B, run by Nucorion Pharmaceuticals, Inc. at 1 site in United States.
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 13 inclusion and 10 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 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 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?
Change in hepatitis B virus (HBV) DNA (time frame: Up to Week 4). 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 4 Jan 2023.