Hepatitis b & Liver DysfunctionPhase 1NCT04123769
Study on PK of Hydronidone in Patients and Special Population
A Phase 1 study testing Hydronidone in people with Hepatitis b & Liver Dysfunction, run by Beijing Continent Pharmaceutical Co, Ltd. at 1 site in China.
Trial summary
1. Evaluate the pharmacokinetic (PK) characteristics of Hydronidone capsule in target patients (patients with chronic viral hepatitis b with liver fibrosis) and special population (patients with mild liver dysfunction). 2. 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 & Liver Dysfunction
- What is being tested?
- Hydronidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2019to 30 Jan 2021
- 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
- Age 18-65 years (including 18 and 65 years);
- BMI 18-26 (including 18 and 26) [BMI= weight (kg)/height 2 (m2)];
- History of chronic hepatitis b, HBsAg positive ≥6 months;
- ALT < 5 times ULN (standard upper limit);
- TBiL < 2 times ULN (standard upper limit);
- ALP < 1.5 times ULN (standard upper limit);
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- Liver elastic hardness test confirmed significant liver fibrosis (LSM≥ 7.3kpa);
- Scores assessed by child-pugh system are 5 or 6;
- Patients currently receiving antiviral treatment with entecavir;
- The subject (or his/her partner) has no pregnancy plan during and within 6 months after the trial and voluntarily takes effective physical contraception and has no sperm or egg donation plan;
- Before the trial, I have had a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential risks of the trial, and I have volunteered to participate in the clinical trial. I am able to communicate well with the investigator, comply with the requirements of the whole study, and have signed a written informed consent.
Who cannot join
- Those who do not meet any of the inclusion criteria;
- (consultation) participants in clinical trials of other drugs in recent 3 months;
- (consultation) any drugs that inhibit or induce drug metabolism in the liver (common liver enzyme inducers: barbiturates (phenobarbital is the most common), carbamazepine, aminoximate, griseofulvin, aminopropyl ester, phenytoin, gromitol, rifampin, dexamethasone; Common liver enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamide);
- (consultation) select those who drank excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups a day, 1 cup =250mL) every day during the first three months; Or from the screening to -1 days after admission, intake of any food or drink containing caffeine and xanthine (such as coffee, strong tea, chocolate, etc.) and other special diet that affects the absorption, distribution, metabolism and excretion of drugs;
- (consultation) patients who had taken food or drinks containing enzymes that can induce or inhibit liver metabolism (e.g., grapefruit, mango, pitaya, grape juice, orange juice and other compounds rich in flavonoids or citrus glycosides) before admission were screened.
- (consultation) screening: drinking more than 14 standard units of alcohol per week in the first 3 months (1 standard unit contains 14g of alcohol, such as 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine); Or cannot abstain from alcohol during the test period; Or taking any alcohol products within 24 hours before the first dose of the study;
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- (consultation) select those who smoke more than 5 cigarettes per day within the first 3 months, or cannot stop using any tobacco products during the trial; Screening for smoking or using any tobacco products up to admission;
- (consultation) previous history of drug abuse and drug abuse;
- (consultation) patients with upper gastrointestinal massive bleeding or active peptic ulcer within the first 3 months were enrolled;
- (consultation) patients with serious diseases of cardiovascular, pulmonary, renal, endocrine, nervous and blood systems and mental disorders;
- (consultation) allergy: if allergic to two or more drugs or food; Lactose intolerant;
- AFP > 100 μg /L;
- B ultrasound showed obvious space-occupying lesions in the liver, suggesting tumor;
- Patients with decompensated liver cirrhosis;
- Patients with malignant tumors;
- Received non-entecavir nucleoside analogues or interferon antiviral therapy within 3 months before inclusion;
- Pregnant and/or lactating women;
- Subjects who are legally disabled according to the law of the People's Republic of China on the protection of disabled persons (April 2008);
- Alcohol breath test results greater than 0.0mg/100mL;
- Positive urine drug screening;
- Patients with suspected poor compliance;
- The investigator considers that there are any circumstances that may affect the subject's informed consent or adherence to the study protocol, or participation in the study may affect the results of the study or their own safety.
Trial locations and contacts
1 site in 1 country.
China1 site
Medical ethics committee of wuhan infectious disease hospital
Wuhan, Hubei
About this study
Official title: Pharmacokinetics of Hydronidone Capsules in Patients With Chronic Hepatitis B Complicated With Liver Fibrosis and Mild Hepatic Insufficiency
- Evaluate the pharmacokinetic (PK) characteristics of Hydronidone capsule in target patients (patients with chronic viral hepatitis b with liver fibrosis) and special population (patients with mild liver dysfunction).
- To evaluate the effect of oral Hydronidone capsule on QT/QTc in patients with chronic viral hepatitis b accompanied by hepatic fibrosis and mild hepatic dysfunction.
- Conditions
- Hepatitis b & Liver Dysfunction
- Being tested
- Hydronidone
- Medical subject headings
- Hepatitis B, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydronidoneDrug
First take Hydronidone capsule, single-dose and then Multiple-dose
| Study group | Role | What they receive |
|---|---|---|
| Drug group | Experimental | Not described Receives: Drug: Hydronidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: up to 24 weeks
Tmax
Measured: up to 24 weeks
AUC
Measured: up to 24 weeks
QT/QTc
Measured: up to 24 weeks
Secondary outcomes (1)
CL/F
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start3 Sep 2019
- Primary completion9 Oct 2020
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis b & Liver DysfunctionStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123769
- Sponsor's protocol ID
- GNI-F351-201901
- Status last verified
- Mar 2021
- First submitted
- 10 Oct 2019
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Hydronidone Capsules in Patients With Chronic Hepatitis B Complicated With Liver Fibrosis and Mild Hepatic Insufficiency
- ClinicalTrials.gov ID
- NCT04123769
- Acronym / sponsor ID
- GNI-F351-201901
- Conditions
- Hepatitis b & Liver Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 9 Oct 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 11 Oct 2019 (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.
- Evaluate the pharmacokinetic (PK) characteristics of Hydronidone capsule in target patients (patients with chronic viral hepatitis b with liver fibrosis) and special population (patients with mild liver dysfunction).
- To evaluate the effect of oral Hydronidone capsule on QT/QTc in patients with chronic viral hepatitis b accompanied by hepatic fibrosis and mild hepatic dysfunction.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug group | Experimental | Drug: Hydronidone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-65 years (including 18 and 65 years);
- BMI 18-26 (including 18 and 26) [BMI= weight (kg)/height 2 (m2)];
- History of chronic hepatitis b, HBsAg positive ≥6 months;
- ALT < 5 times ULN (standard upper limit);
- TBiL < 2 times ULN (standard upper limit);
Key exclusion criteria (22 listed)
- Those who do not meet any of the inclusion criteria;
- (consultation) participants in clinical trials of other drugs in recent 3 months;
- (consultation) any drugs that inhibit or induce drug metabolism in the liver (common liver enzyme inducers: barbiturates (phenobarbital is the most common), carbamazepine, aminoximate, griseofulvin, aminopropyl ester, phenytoin, gromitol, rifampin, dexamethasone; Common liver enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamide);
- (consultation) select those who drank excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups a day, 1 cup =250mL) every day during the first three months; Or from the screening to -1 days after admission, intake of any food or drink containing caffeine and xanthine (such as coffee, strong tea, chocolate, etc.) and other special diet that affects the absorption, distribution, metabolism and excretion of drugs;
- (consultation) patients who had taken food or drinks containing enzymes that can induce or inhibit liver metabolism (e.g., grapefruit, mango, pitaya, grape juice, orange juice and other compounds rich in flavonoids or citrus glycosides) before admission were screened.
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 |
|---|---|---|
| HydronidoneFirst take Hydronidone capsule, single-dose and then Multiple-dose | Drug | Drug group |
Primary outcome
Cmax
Time frame: up to 24 weeks
Tmax
Time frame: up to 24 weeks
AUC
Time frame: up to 24 weeks
QT/QTc
Time frame: up to 24 weeks
1 secondary outcome
CL/F
Time frame: up to 24 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 24 Mar 2021.
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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.
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 Hydronidone in people with Hepatitis b & Liver Dysfunction, run by Beijing Continent Pharmaceutical Co, Ltd. at 1 site in China.
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 11 inclusion and 22 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 24 Mar 2021. 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 China. 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?
Cmax (time frame: up to 24 weeks). The study lists 4 primary outcomes in all. 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 24 Mar 2021.