Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis

This study is currently recruiting participants.
Verified December 2013 by Zhejiang Hisun Pharmaceutical Co. Ltd.
Sponsor:
Information provided by (Responsible Party):
Zhejiang Hisun Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier:
NCT01998620
First received: November 14, 2013
Last updated: December 1, 2013
Last verified: December 2013
  Purpose

This is an evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety of multicenter, randomized, open label clinical trial.


Condition Intervention Phase
Hepatitis B
Cholestasis
Drug: Ademetionine 2
Drug: Ademetionine 1
Drug: Ademetionine 3
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis

Resource links provided by NLM:


Further study details as provided by Zhejiang Hisun Pharmaceutical Co. Ltd.:

Primary Outcome Measures:
  • levels of serum total bilirubin declined from baseline [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    levels of serum total bilirubin declined from baseline


Secondary Outcome Measures:
  • level of serum direct bilirubin decline from baseline [ Time Frame: 2 weeks, 6 weeks, 10 weeks ] [ Designated as safety issue: Yes ]
    level of serum direct bilirubin decline from baseline

  • level of serum bile acids decline from baseline [ Time Frame: 2 weeks, 6 weeks, 10 weeks ] [ Designated as safety issue: Yes ]
    level of serum bile acids decline from baseline

  • glutamic pyruvic transaminase [ Time Frame: 2 weeks, 6 weeks, 10 weeks ] [ Designated as safety issue: Yes ]
    glutamic pyruvic transaminase

  • glutamic oxaloacetic transaminase [ Time Frame: 2 weeks, 6 weeks, 10 weeks ] [ Designated as safety issue: Yes ]
    glutamic oxaloacetic transaminase

  • Alkaline Phosphatase [ Time Frame: 2 weeks, 6 weeks, 10 weeks ] [ Designated as safety issue: Yes ]
    Alkaline Phosphatase

  • Gamma-Glutamyl Transpeptidace [ Time Frame: 2 weeks, 6 weeks, 10 weeks ] [ Designated as safety issue: Yes ]
    Gamma-Glutamyl Transpeptidace


Estimated Enrollment: 240
Study Start Date: November 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ademetionine 1
Ademetionine 2000mg
Drug: Ademetionine 1
Ademetionine 2000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks
Experimental: Ademetionine 2
Ademetionine 1000mg
Drug: Ademetionine 2
Ademetionine 1000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 500mg po bid with general antiviral treatment for 8 weeks
Active Comparator: Ademetionine 3
no treatment in first 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks
Drug: Ademetionine 3
no treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks

Detailed Description:

evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. from 18-65 years old
  2. diagnosed as hepatitis B, previous has HBV or HBsAg(+)>6 months, and now HBsAg or HBV DNA(+)
  3. HBeAg(+) and HBV DNA>1X10-4/ml, or HBeAg(-) and HBV DNA>1X10-3/ml
  4. with intrahepatic cholestasis: meet EASL 2009 diagnoses critera ALP>1.5ULN,GGT>3ULN
  5. STB>2ULN
  6. ALT>1.5ULN
  7. Have signed informed consent

Exclusion Criteria:

  1. with other virus infection, anti-HCV or anti-HDV or anti-HIV(+)
  2. been treated with immune modulators(IFN or Thymosin, IL12 or others) within 6 months
  3. Prothrombin activity<40% or INR>1.68
  4. blood ammonia>1.5ULN
  5. ALT increased by other reasons
  6. with ascites, gastrointestinal bleeding, hepatic encephalopathy or spontaneous peritonitis, one of above
  7. diabetes mellitus patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01998620

Contacts
Contact: Liang Chen 00862137990333 chenlian@shaphl.org

Locations
China, Shanghai
Public Health Clinical Center Affiliated to Fudan University Recruiting
Shanghai, Shanghai, China, 200000
Contact: Liang Chen, Doctor    00862137990333    chenlian@shaphl.org   
Sponsors and Collaborators
Zhejiang Hisun Pharmaceutical Co. Ltd.
Investigators
Principal Investigator: Liang Chen Public Health Clinical Center Affiliated to Fudan University
  More Information

No publications provided

Responsible Party: Zhejiang Hisun Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT01998620     History of Changes
Other Study ID Numbers: XMX-HBV-001
Study First Received: November 14, 2013
Last Updated: December 1, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Zhejiang Hisun Pharmaceutical Co. Ltd.:
Hepatitis B
Cholestasis

Additional relevant MeSH terms:
Hepatitis B
Hepatitis B, Chronic
Cholestasis
Hepatitis
Hepatitis A
Hepatitis, Chronic
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Liver Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014