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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01998620
Recruitment Status : Unknown
Verified May 2014 by Zhejiang Hisun Pharmaceutical Co. Ltd..
Recruitment status was:  Recruiting
First Posted : December 2, 2013
Last Update Posted : May 29, 2014
Sponsor:
Information provided by (Responsible Party):
Zhejiang Hisun Pharmaceutical Co. Ltd.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis B Cholestasis Drug: Ademetionine 2 Drug: Ademetionine 1 Drug: Ademetionine 3 Phase 4

Detailed Description:
evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis
Study Start Date : November 2013
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. levels of serum total bilirubin declined from baseline [ Time Frame: 2 weeks ]
    levels of serum total bilirubin declined from baseline

  2. Alkaline Phosphatase [ Time Frame: 10 weeks ]
    Alkaline Phosphatase

  3. Gamma-Glutamyl Transpeptidase [ Time Frame: 10 weeks ]
    Gamma-Glutamyl Transpeptidase


Secondary Outcome Measures :
  1. level of serum direct bilirubin decline from baseline [ Time Frame: 2 weeks, 6 weeks, 10 weeks ]
    level of serum direct bilirubin decline from baseline

  2. level of serum bile acids decline from baseline [ Time Frame: 2 weeks, 6 weeks, 10 weeks ]
    level of serum bile acids decline from baseline

  3. glutamic pyruvic transaminase [ Time Frame: 2 weeks, 6 weeks, 10 weeks ]
    glutamic pyruvic transaminase

  4. glutamic oxaloacetic transaminase [ Time Frame: 2 weeks, 6 weeks, 10 weeks ]
    glutamic oxaloacetic transaminase


Eligibility Criteria
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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. from 18-65 years old
  2. diagnosed as hepatitis B, previous has HBV or HBsAg(+)>6 months, and now HBsAg or HBV DNA(+)
  3. with intrahepatic cholestasis: meet EASL 2009 diagnoses criteria ALP>1.5ULN and GGT>3ULN or STB>2ULN

Exclusion Criteria:

  1. liver mass, liver carcinoma
  2. liver failure
  3. non-hepatic diseases caused jaundice
  4. obstructive jaundice
Contacts and Locations
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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): NCT01998620


Contacts
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Contact: Liang Chen 00862137990333 chenlian@shaphl.org

Locations
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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
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Principal Investigator: Liang Chen Public Health Clinical Center Affiliated to Fudan University
More Information
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Responsible Party: Zhejiang Hisun Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT01998620    
Other Study ID Numbers: XMX-HBV-001
First Posted: December 2, 2013    Key Record Dates
Last Update Posted: May 29, 2014
Last Verified: May 2014
Keywords provided by Zhejiang Hisun Pharmaceutical Co. Ltd.:
Hepatitis B
Cholestasis
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Cholestasis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Bile Duct Diseases
Biliary Tract Diseases