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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.

Tracking Information
First Submitted Date  ICMJE June 26, 2015
First Posted Date  ICMJE July 16, 2015
Last Update Posted Date July 16, 2015
Study Start Date  ICMJE July 2015
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2015)
Changes in hepatic fibrosis in chronic viral hepatitis B [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis
Official Title  ICMJE Randomed and Double-blinded Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis
Brief Summary To explore the effective dose and safety of the effect of hydronidone and entecavir on hepatic fibrosis in chronic viral hepatitis B.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis B, Chronic
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: Hydronidone
    • 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.

    Interventions:
    • Drug: Hydronidone
    • 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.

    Interventions:
    • Drug: Hydronidone
    • 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.
    Interventions:
    • Drug: Placebo
    • Drug: Entecavir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 13, 2015)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02499562
Other Study ID Numbers  ICMJE GNI-F351-201402
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shanghai Genomics, Inc.
Study Sponsor  ICMJE Shanghai Genomics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: LunGen Lu Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
PRS Account Shanghai Genomics, Inc.
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP