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A Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis (HBV)

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ClinicalTrials.gov Identifier: NCT02499562
Recruitment Status : Unknown
Verified May 2015 by Shanghai Genomics, Inc..
Recruitment status was:  Recruiting
First Posted : July 16, 2015
Last Update Posted : July 16, 2015
Sponsor:
Information provided by (Responsible Party):
Shanghai Genomics, Inc.

Brief Summary:
To explore the effective dose and safety of the effect of hydronidone and entecavir on hepatic fibrosis in chronic viral hepatitis B.

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: Hydronidone Drug: Placebo Drug: Entecavir Phase 2

Detailed Description:

Primary observation indexes:

Hepatic fibrosis Ishak score after treatment decreases by the proportion not less than 1 compared with that before treatment.

Secondary observation indexes :

  1. Negative conversion ratio of HBV DNA after treatment (HBV DNA<1×103copies/mL) and falling range.
  2. The falling proportion of Fibrocan Kpa value after treatment compared with that before treatment.
  3. The falling proportion that decreases not less than 1 level and progression-free fibrosis after treatment compared with that before treatment.
  4. The improvement of ALT of liver function.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomed and Double-blinded Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis
Study Start Date : July 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Entecavir

Arm Intervention/treatment
Experimental: Hydronidone(180mg) & Entecavir & Placebo

hydronidone capsule 30mg/capsule hydronidone capsule, three times a day, 2 capsules each time; with co-administration of placebo capsule, three times a day, 2 capsules each time, namely the daily dose of the investigational product is 180mg.

The test groups and the control group take the entecavir capsule which is orally taken for antiviral therapy, one time a day, 0.5mg each time, oral administration on an empty stomach.

Drug: Hydronidone
The investigational products in the test groups and control group shall be orally taken 30 minutes before meals for 52 continuous weeks. There are respectively 60 cases in the test group I, II, III and the control group, totally 240 cases.
Other Name: F351

Drug: Placebo
Drug: Entecavir
Experimental: Hydronidone(270mg) & Entecavir & Placebo

hydronidone capsule 30mg/capsule hydronidone capsule, three times a day, 3 capsules each time; with co-administration of placebo capsule, three times a day, 1 capsules each time, namely the daily dose of the investigational product is 270mg.

The test groups and the control group take the entecavir capsule which is orally taken for antiviral therapy, one time a day, 0.5mg each time, oral administration on an empty stomach.

Drug: Hydronidone
The investigational products in the test groups and control group shall be orally taken 30 minutes before meals for 52 continuous weeks. There are respectively 60 cases in the test group I, II, III and the control group, totally 240 cases.
Other Name: F351

Drug: Placebo
Drug: Entecavir
Experimental: Hydronidone(360mg) & Entecavir

hydronidone capsule 30mg/capsule hydronidone capsule, three times a day, 4 capsules each time; namely the daily dose of the investigational product is 360mg.

The test groups and the control group take the entecavir capsule which is orally taken for antiviral therapy, one time a day, 0.5mg each time, oral administration on an empty stomach.

Drug: Hydronidone
The investigational products in the test groups and control group shall be orally taken 30 minutes before meals for 52 continuous weeks. There are respectively 60 cases in the test group I, II, III and the control group, totally 240 cases.
Other Name: F351

Drug: Entecavir
Experimental: Entecavir & Placebo(360mg)
placebo capsule 30mg/capsule placebo capsule, three times a day, 4 capsules each time. The test groups and the control group take the entecavir capsule which is orally taken for antiviral therapy, one time a day, 0.5mg each time, oral administration on an empty stomach.
Drug: Placebo
Drug: Entecavir



Primary Outcome Measures :
  1. Changes in hepatic fibrosis in chronic viral hepatitis B [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 18-65, all genders.
  2. History of chronic hepatitis B, HBsAg positive≧six months.
  3. ALT<five-fold ULN (maximum).
  4. Significant liver fibrosis confirmed by liver biopsy.
  5. HBeAg positive patients, HBV DNA>2.0×104 IU/mL (copies/mL); HBeAg negative patients,HBV DNA>2.0×103 IU/mL (104copies/mL).
  6. Having not accepted the antiviral therapy with interferon and/or nucleoside analog.
  7. Having not taken anti-inflammatory drugs to protect liver within 1 month before selection.
  8. Capable of understanding and signing the informed consent before the study.

Exclusion Criteria:

  1. Failing to meet any one requirement of the inclusion criteria.
  2. Having suffered massive hemorrhage of gastrointestinal tract within 3 months before selection
  3. TBiL>three-fold ULN.
  4. AFP>50 ug/L
  5. PLT≦60000ug/L
  6. Having obvious space-occupying lesion in liver as shown by B ultrasound examination.
  7. With a portal vein ≧1.2cm wide as shown by B ultrasound examination.
  8. BMI index>30.
  9. The patient who suffered from liver function decompensation hepatic cirrhosis and liver neoplasms.
  10. The patient with alcoholic, drug-induced, hereditary, immune and other viral and non- viral chronic hepatitis.
  11. The patient with angiocarpy, lung, kidney, incretion, nerve and blood system disease and mental disease.
  12. The patient with active peptic ulcer.
  13. Gestational and breast feeding women.
  14. The subject is the legal disabled person according to the Law of the People's Republic of China on the Protection of Disabled Persons of the April 2008 edition.
  15. The subject who participated in other drug tests within recent 3 months.
  16. The patient who is suspected with poor compliance or disagrees to participate in the test.
  17. The patient who is considered by other investigators not to be suitable for participating in the study.

Information from the National Library of Medicine

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): NCT02499562


Contacts
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Contact: LunGen Lu +8613381616206 lungenlu1965@163.com

Locations
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China, Shanghai
Shanghai General Hospital Recruiting
Shanghai, Shanghai, China
Contact: LunGen Lu    13381616206    lungenlu1965@163.com   
Sponsors and Collaborators
Shanghai Genomics, Inc.
Investigators
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Principal Investigator: LunGen Lu Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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Responsible Party: Shanghai Genomics, Inc.
ClinicalTrials.gov Identifier: NCT02499562    
Other Study ID Numbers: GNI-F351-201402
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: July 16, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Fibrosis
Pathologic Processes
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Entecavir
Antiviral Agents
Anti-Infective Agents