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Trial record 137 of 361 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Shanghai Genomics, Inc.
Sponsor:
Information provided by (Responsible Party):
Shanghai Genomics, Inc.
ClinicalTrials.gov Identifier:
NCT02499562
First received: June 26, 2015
Last updated: July 13, 2015
Last verified: May 2015
  Purpose
To explore the effective dose and safety of the effect of hydronidone and entecavir on hepatic fibrosis in chronic viral hepatitis B.

Condition Intervention Phase
Hepatitis B, Chronic
Drug: Hydronidone
Drug: Placebo
Drug: Entecavir
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Shanghai Genomics, Inc.:

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

Estimated Enrollment: 240
Study Start Date: July 2015
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02499562

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

Locations
China, Shanghai
Shanghai General Hospital Recruiting
Shanghai, Shanghai, China
Contact: LunGen Lu    13381616206    lungenlu1965@163.com   
Sponsors and Collaborators
Shanghai Genomics, Inc.
Investigators
Principal Investigator: LunGen Lu Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  More Information

Responsible Party: Shanghai Genomics, Inc.
ClinicalTrials.gov Identifier: NCT02499562     History of Changes
Other Study ID Numbers: GNI-F351-201402
Study First Received: June 26, 2015
Last Updated: July 13, 2015

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 23, 2017