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Liver FibrosisPhase 3NCT05115942

Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Viral Hepatitis B Phase 3 Trial.

A Phase 3 study testing Hydronidone capsules in people with Liver Fibrosis, run by Beijing Continent Pharmaceutical Co, Ltd. at 44 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study was a randomized, double-blind, placebo-controlled, entecavir basic treatment, multicentre clinical study. The main objective of this study was to confirm the efficacy and safety of hydronidone in the treatment of chronic hepatitis B liver fibrosis. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Liver Fibrosis
What is being tested?
Hydronidone capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
248 participants
Where
44 sitesChina
Study dates
30 Dec 2021to 22 Oct 2024
Phase
Phase 3
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

  • Age from 18 to 65 years old (including 18 and 65 years old, based on the time of signing the written informed consent); gender is not limited.
  • History of chronic hepatitis B and/or hepatitis B surface antigen (HBsAg) positive≥6 months.
  • Percutaneous liver biopsy confirmed liver fibrosis (Ishak score ≥3).
  • Positive HBV DNA.
  • ALT < 8 x ULN (standard upper limit).
  • No antiviral therapy with interferon and/or nucleoside analogues within 3 months prior to enrollment.
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  • 3 months before inclusion, he/she had not received any of the following proprietary Chinese medicines that may have anti-fibrosis effects: Fuzheng Huayu Capsule (tablet), Anluo Huayu Pill, compound Bijiaruangan tablet, etc.
  • The subject (or his/her sexual partner) had no pregnancy plan during the trial period and within 6 months after the trial, voluntarily used effective physical contraception, and had no sperm or egg donation plan.
  • Before the trial, they have understood the nature, significance, potential benefits, inconvenience and potential dangers of the trial in detail, and have voluntarily participated in the clinical trial, have good communication with the researchers, comply with the requirements of the whole study, and have signed a written informed consent form.

Who cannot join

  • Massive upper gastrointestinal hemorrhage within 3 months before enrolment.
  • Total bilirubin (TBiL) > 3×ULN, or 3×ULN < ALT < 8×ULN and TBiL > 2×ULN.
  • AFP > 100 μg/L although there was no indication of liver cancer.
  • Platelets (PLT) ≤60×109/L.
  • Prothrombin activity (PTA) < 50% or INR > 1.5.
  • Imaging showed obvious space-occupying lesions in the liver, suggesting tumor.
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  • Body mass index (BMI) > 30 kg/m2.
  • Patients with decompensated liver cirrhosis and liver malignant tumor.
  • Patients with chronic hepatitis C or non-viral (alcoholic, non-alcoholic, drug, etc.) chronic hepatitis.
  • Serious diseases of cardiovascular, pulmonary, renal, endocrine, neurological and haematological systems, as well as mental disorders .
  • Women who are pregnant and/or breastfeeding.
  • Have participated in clinical trials of other drugs in the last 3 months.
  • The Investigator considers that there are any conditions that may affect the subjects' informed consent or adherence to the study protocol, or participation in the study may affect the study results or their own safety.

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

China44 sites

  • Beijing Ditan Hospital Capital Medical University

    Beijing, Beijing Municipality, 100020

  • Beijing You 'an Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Peking University First Hospital

    Beijing, Beijing Municipality

  • Tsinghua Changgeng Hospital, Beijing

    Beijing, Beijing Municipality

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui

  • The First Affiliated Hospital of Hunan University of Chinese Medicine

    Changsha, Hunan

  • The Second Xiangya Hospital, Central South University

    Changsha, Hunan

  • Xiangya Hospital, Central South University

    Changsha, Hunan

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

  • Chongqing Public Health Medical Treatment Center (Chongqing Infectious Disease Hospital)

    Chongqing, Chongqing Municipality

  • Chongqing Three Gorges Central Hospital

    Chongqing, Chongqing Municipality

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • The First Affiliated Hospital of Fujian Medical University

    Fujian, Fujian

  • Guizhou Provincial People's Hospital

    Guizhou, Guizhou

  • Hangzhou Xixi Hospital (Hangzhou Sixth People's Hospital)

    Hangzhou, Hangzhou

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • The First Hospital of Hebei Medical University

    Hebei, Hebei

  • The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

    Hefei, Anhui

  • Henan Provincial People's Hospital

    Henan, Henan

  • First Hospital of Jilin University

    Jilin City, Jilin

  • Second Hospital of Jilin University

    Jilin City, Jilin

  • Lanzhou university first hospital

    Lanzhou, Gansu

  • Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University

    Luzhou, Sichuan

  • Nanchang Ninth Hospital (Nanchang Central Hospital)

    Nanchang, Jiangxi

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu

  • Ningbo Huamei Hospital, University of Chinese Academy of Sciences

    Ningbo, Zhejiang

  • Shanghai General Hospital,Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality, 201620

  • Huashan Hospital affiliated to Fudan University

    Shanghai, Shanghai Municipality

  • Shanghai Jiao Tong University Affiliated Tongren Hospital

    Shanghai, Shanghai Municipality

  • Shanghai Public Health Clinical Center

    Shanghai, Shanghai Municipality

  • Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality

  • Shenzhen Third People's Hospital

    Shenzhen, Guangdong

  • The First Affiliated Hospital of SuZhou University

    Suzhou, Jiangsu

  • Taizhou People's Hospital

    Taizhou, Jiangsu

  • Wuxi Fifth People's Hospital

    Wuxi, Jiangsu

  • Xiamen Hospital of Traditional Chinese Medicine

    Xiamen, Fujian

  • The First Affiliated Hospital of Xinxiang Medical College

    Xinxiang, Henan

  • Affiliated Hospital of Xuzhou Medical College

    Xuzhou, Jiangsu

  • Yanbian University Affiliated Hospital

    Yanbian, Jilin

  • The First Affiliated Hospital of University of South China

    Yueyang, Hunan

  • Zhengzhou Sixth People's Hospital

    Zhengzhou, Henan

  • Zhenjiang Third People's Hospita

    Zhenjiang, Jiangsu

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Entecavir-based, Phase III Clinical Trial of Hydronidone Capsule in the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B

This study was a randomized, double-blind, placebo-controlled, entecavir basic treatment, multicentre clinical study.

The main objective of this study was to confirm the efficacy and safety of hydronidone in the treatment of chronic hepatitis B liver fibrosis.

Read the detailed description

248 patients with chronic viral hepatitis B liver fibrosis were enrolled in this 52-week study, and randomized into hydronidone or placebo group. Each group has 124 patients. Both groups were treated with entecavir antiviral basic therapy.

Conditions
Liver Fibrosis
Being tested
Hydronidone capsules, The placebo capsules
Medical subject headings
Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hydronidone capsulesDrug

    Also called F351

    After randomization, the experimental group were orally received hydronidone capsules at a daily dose of 270 mg, 3 capsules each time, t.i.d,30 min before meals for 52 weeks.

  • The placebo capsulesDrug

    Also called N

    After randomization, The control group were orally received placebo capsules at a daily dose of 270 mg, 3 capsules each time, t.i.d, 30 min before meals for 52 weeks.

Study groups in NCT05115942
Study groupRoleWhat they receive
Hydronidone groupExperimentalPatients were orally received hydronidone capsules,3 capsules each time, t.i.d. for 52 weeks.
Receives: Drug: Hydronidone capsules
The placebo groupPlacebo comparatorPatients were orally received placebo capsules,3 capsules each time, t.i.d. for 52 weeks.
Receives: Drug: The placebo capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Ishak stage score of liver fibrosis by greater than or equal to 1 point after 52 weeks of treatment relative to baseline.

    Clinically, the liver pathology scoring system, Ishak system, is widely used make a detailed and accurate assessment of the degree of parenchymal fibrosis or cirrhosis of the nontumorous liver. Ishak system uses a scale of 7 stages (scores 0-6) for the degree of fibrosis; the higher the score, the higher degree the severity of the disease.

    Measured: 52 weeks

Secondary outcomes (14)

  1. Change in liver inflammation grade by greater than or equal to 1 grade after 52 weeks of treatment relative to baseline but with no progression of fibrosis.

    Scheuer score system is a liver pathology scoring system used for the diagnosis of liver inflammation and fibrosis pathology clinically; In the present trial, Scheuer system for scoring necroinflammatory activitt in chronic hepatitis will be used(G0-G4),the higher the score, the higher degree the severity of the disease.

    Measured: 52 weeks

  2. Change in liver tissue inflammation grade by greater than or equal to 1 grade after 52 weeks of treatment relative to baseline.

    Scheuer score system is a liver pathology scoring system used for the diagnosis of liver inflammation and fibrosis pathology clinically; In the present trial, Scheuer system for scoring necroinflammatory activitt in chronic hepatitis will be used(G0-G4),the higher the score, the higher degree the severity of the disease.

    Measured: 52 weeks

  3. Change in liver stiffness measurement values via transient elastography LSM (kPa)

    Change in liver stiffness measurement values via transient elastography LSM (kPa) values relative to baseline after 52 weeks of treatment.

    Measured: Screening period/baseline and weeks 12, 24, 36, and 52 after treatment .

  4. Negative conversion (below the lower limit of detection) and the extent of decrease in HBV DNA

    Negative conversion (below the lower limit of detection) and the extent of decrease in HBV DNA after 52 weeks of treatment.

    Measured: Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.

  5. Normalization and the degree of improvement of the indicators of liver function ALT after 52 weeks of treatment.

    ALT is one of the indicators to assess liver function and detect liver damage. When hepatic cells are affected by injury or disease, ALT is released into the blood, resulting in elevated ALT levels in the blood.

    Measured: Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.

  6. Safety endpoints:Laboratory examination（AFP test）

    AFP test: the serum AFP will be detected.

    Measured: Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.

  7. Safety endpoints:AE

    Adverse events (AEs) refer to any adverse medical events that occur after the patient takes the study drug and can manifest as signs and symptoms, disease, or abnormal laboratory tests, but are not necessarily consequently related to the study drug.

    Information on AEs and Concomitant medications occurring in patients will be collected at the time points specified in the study schedule. AEs will be evaluated with reference to the Common Adverse Events Evaluation Criteria (NCI-CTCAE version 5.0).

    Measured: 52 weeks

  8. Safety endpoints:Laboratory examination（Metabolic panel-AST）

    Metabolic panel: The panel includes aspartate aminotransferase (AST)，which is one of the indicators to assess liver function and detect liver damage.

    Measured: Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.

  9. Safety endpoints:Laboratory examination（Metabolic panel-GGT）

    Metabolic panel: The panel includes gamma-glutamyl transpeptidase (GGT),which is one of the indicators to assess liver function .

    Measured: Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.

  10. Safety endpoints:Laboratory examination（Metabolic panel-ALP）

    Metabolic panel: The panel includes alkaline phosphatase (ALP),which is one of the indicators to assess liver function .

    Measured: Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.

  11. Safety endpoints:Laboratory examination（Metabolic panel-TP）

    Metabolic panel: The panel includes total protein (TP), which is one of the indicators to assess liver function .

    Measured: Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.

  12. Safety endpoints:Laboratory examination（Metabolic panel-A）

    Metabolic panel: The panel includes albumin (A) , which is one of the indicators to assess liver function .

    Measured: Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.

  13. Safety endpoints:Laboratory examination（Metabolic panel-TBiL）

    Metabolic panel: The panel includes total bilirubin (TBiL) , which is one of the indicators to assess liver function .

    Measured: Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.

  14. Safety endpoints:Laboratory examination（Metabolic panel-DBiL）

    Metabolic panel: The panel includes direct bilirubin (DBiL) , which is one of the indicators to assess liver function .

    Measured: Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2021
  2. Study start30 Dec 2021
  3. Primary completion22 Oct 2024
  4. Study completion22 Oct 2024

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05115942
Sponsor's protocol ID
KDN-F351-202101
Status last verified
Aug 2024
First submitted
9 Oct 2021
Last updated
20 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hydronidone capsules in people with Liver Fibrosis, run by Beijing Continent Pharmaceutical Co, Ltd. at 44 sites 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 9 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 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Ishak stage score of liver fibrosis by greater than or equal to 1 point after 52 weeks of treatment relative to baseline. (time frame: 52 weeks). 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 NCT05115942.

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 20 Dec 2024.

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