Hydroxynidone Capsules in Long-term Treatment in Patients With Chronic Viral Hepatitis B Liver Fibrosis
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| ClinicalTrials.gov Identifier: NCT05905172 |
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Recruitment Status :
Recruiting
First Posted : June 15, 2023
Last Update Posted : January 17, 2024
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This study is a Phase IIIb extension trial following the "randomized, double-blind, placebo-controlled, entecavir basic treatment, multi-center Phase III clinical trial of hydroxnidone capsules in the treatment of liver fibrosis of chronic viral hepatitis B".
The main objective of this study is to evaluate the effectiveness and the safety of hydroxyeidone capsules for long-term treatment of patients with chronic viral hepatitis B liver fibrosis.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Liver Fibrosis | Drug: Hydronidone capsules Drug: The placebo capsules | Phase 3 |
Nowadays, there is no satisfactory treatment and drug for liver fibrosis, so the etiology treatment of liver fibrosis and cirrhosis is the most important treatment. However, the etiology and treatment can not completely prevent the progression of liver fibrosis, and liver cirrhosis and liver cancer still occur after antiviral treatment. Although some drugs in domestic and foreign clinical trials have reported the effect of treating liver fibrosis, there is no recognized effective chemical drugs or biological agents against liver fibrosis. According to the available evidence, hydroxnidone capsules can effectively reduce the severity of liver fibrosis, which is expected to further reduce the risk of clinical endpoint events. Since the clinical benefit from the improvement of liver fibrosis usually takes a long time to observe, this trial takes an extended treatment approach to continuously evaluate the clinical benefit of subjects undergoing long-term treatment with hydroxylnidone capsules in patients with liver fibrosis.
This study is a Phase IIIb extension trial following the "randomized, double-blind, placebo-controlled, entecavir basic treatment, multi-center Phase III clinical trial of hydroxnidone capsules in the treatment of liver fibrosis of chronic viral hepatitis B". Subjects who have completed the Phase III, placebo-controlled design, double-blind, can enter the study and continue treatment according to the original treatment protocol.The aim is to evaluate the effectiveness and the safety of hydroxyeidone capsules for long-term treatment of patients with chronic viral hepatitis B liver fibrosis.
The test group received hydroxnidone capsules three times a day at a daily dose of 270 mg and oral medication half an hour before the meal. The control group received placebo capsules three times a day, half an hour before the meal.Both the test and control groups received entecavir antiviral therapy as basic treatment, once daily at 0.5 mg each, by fasting oral administration. If the subject is not suitable for entecavir, the investigator will decide on the corresponding antiviral treatment according to the subject's specific condition. Discontinuation criteria for entecavir: According to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2019 edition), the American Association for the Study of Liver Disease (AASLD) and the European Association for Liver Disease (EASL) management guidelines.
Visit examination items: clinical laboratory tests (routine ALT) every 6 months (for ALT and AST, additional tests as appropriate), HBVDNA, hepatitis B, transient elastography examination, etc. In order to improve subject compliance, the investigator may increase or reduce the examination frequency or items, and at least 1 year to reducing the frequency. Additional according to the actual situation
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 248 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Test group: hydroxylidone capsules, three times a day, 3 doses, daily therapeutic dose of 270 mg, half an hour before the meal Oral medicine. Control group: placebo capsules, three times a day, half an hour before the meal. Basic treatment: Both test and control groups were treated with entecavir antiviral therapy, once daily, 0.5 mg per time, fasting oral administration. In case of drug resistance or other conditions requiring dose adjustment, the investigator may adjust the dose and type of basic treatment drug appropriately. |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Before the clinical trial begins, the test drug and placebo are packaged in the same way, and the drug number is marked on the packaging according to the random table. The subjects take the drugs according to the randomly assigned drug number. |
| Primary Purpose: | Treatment |
| Official Title: | A Clinical Study to Evaluate the Efficacy and Safety of Hydroxynidone Capsules in Long-term Treatment in Patients With Chronic Viral Hepatitis B Liver Fibrosis |
| Actual Study Start Date : | August 12, 2023 |
| Estimated Primary Completion Date : | June 20, 2028 |
| Estimated Study Completion Date : | October 20, 2028 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Hydronidone group
Patients were given three capsules of hydronidone three times a day for 5 years.
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Drug: Hydronidone capsules
After randomization, the experimental group received hydronidone capsules three times a day, 3 capsules each time, for 5 years.
Other Name: F351 |
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Placebo Comparator: The placebo group
Patients were given three capsules of placebo three times a day for 5 years.
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Drug: The placebo capsules
After randomization, The control group received three placebo capsules three times a day. 3 capsules each time, for 5 years.
Other Name: N |
- Cumulative incidence of clinical endpoint events (defined as the occurrence of any clinical endpoint event). [ Time Frame: 5years ]For non-cirrhotic patients, clinical endpoints include progression to cirrhosis, decompensated cirrhosis complications [ascites, esophagogastric vein rupture and bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatic encephalopathy, portal vein thrombosis and cirrhotic cardiomyopathy, etc.], hepatocellular carcinoma, liver transplantation or liver disease-related death / all-cause death; for patients with cirrhosis, clinical endpoints include occurrence of decompensated cirrhosis complications, hepatocellular carcinoma, liver transplantation or liver disease-related death or all-cause death.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participate in the Phase III trial of this project (Protocol Number: KDN-F351- 202101 ，ClinicalTrials.gov ID: NCT05115942 ), complete the main treatment course and the last visit;
- Before the trial, the subject understood the nature, significance, possible benefits, possible inconvenience and potential dangers of the trial, volunteered to participate in the clinical trial, was able to communicate well with the investigator, comply with the requirements of the whole study, and signed a written informed consent.
Exclusion Criteria:
- One of any clinical endpoints occurred during the phase III trial (Note: for non cirrhotic patients, Clinical endpoints include progression to cirrhosis,decompensated cirrhosis complications [ascites, esophagogastric vein rupture and bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatopulmonary syndrome, hepatic encephalopathy, portal vein thrombosis and cirrhotic cardiomyopathy], hepatocellular carcinoma, liver transplantation or liver disease related death / all-cause death; For patients with liver cirrhosis, Clinical endpoints include complications of decompensated cirrhosis, hepatocellular carcinoma, liver transplantation, or liver disease-related death / all-cause death);
- Patients with malignant tumors other than hepatocellular carcinoma and with an expected survival period of less than 1 year;
- Any opinion of the investigator that may affect the subject to provide informed consent or follow the trial protocol, or participation in the trial may affect the trial results or their own safety.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05905172
| Contact: Ling Zhang, Dr | +86-13501209210 | zhangling@bjcontinent.com |
Show 35 study locations
| Principal Investigator: | Lungen Lu, Dr | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | |
| Principal Investigator: | Jun Cheng, Dr | Beijing Ditan Hospital |
| Responsible Party: | Beijing Continent Pharmaceutical Co, Ltd. |
| ClinicalTrials.gov Identifier: | NCT05905172 |
| Other Study ID Numbers: |
KDN-F351-202201 |
| First Posted: | June 15, 2023 Key Record Dates |
| Last Update Posted: | January 17, 2024 |
| Last Verified: | January 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Hepatitis B Hepatitis B, Chronic Liver Cirrhosis Fibrosis Hepatitis Liver Diseases Digestive System Diseases Pathologic Processes Blood-Borne Infections |
Communicable Diseases Infections Hepadnaviridae Infections DNA Virus Infections Virus Diseases Hepatitis, Viral, Human Hepatitis, Chronic Chronic Disease Disease Attributes |