Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis B Cholestasis | Drug: Ademetionine 2 Drug: Ademetionine 1 Drug: Ademetionine 3 | Phase 4 |
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 |

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 |
- levels of serum total bilirubin declined from baseline [ Time Frame: 2 weeks ]levels of serum total bilirubin declined from baseline
- Alkaline Phosphatase [ Time Frame: 10 weeks ]Alkaline Phosphatase
- Gamma-Glutamyl Transpeptidase [ Time Frame: 10 weeks ]Gamma-Glutamyl Transpeptidase
- level of serum direct bilirubin decline from baseline [ Time Frame: 2 weeks, 6 weeks, 10 weeks ]level of serum direct bilirubin decline from baseline
- level of serum bile acids decline from baseline [ Time Frame: 2 weeks, 6 weeks, 10 weeks ]level of serum bile acids decline from baseline
- glutamic pyruvic transaminase [ Time Frame: 2 weeks, 6 weeks, 10 weeks ]glutamic pyruvic transaminase
- glutamic oxaloacetic transaminase [ Time Frame: 2 weeks, 6 weeks, 10 weeks ]glutamic oxaloacetic transaminase

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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 |
Inclusion Criteria:
- from 18-65 years old
- diagnosed as hepatitis B, previous has HBV or HBsAg(+)>6 months, and now HBsAg or HBV DNA(+)
- with intrahepatic cholestasis: meet EASL 2009 diagnoses criteria ALP>1.5ULN and GGT>3ULN or STB>2ULN
Exclusion Criteria:
- liver mass, liver carcinoma
- liver failure
- non-hepatic diseases caused jaundice
- obstructive jaundice

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
Contact: Liang Chen | 00862137990333 | chenlian@shaphl.org |
China, Shanghai | |
Public Health Clinical Center Affiliated to Fudan University | Recruiting |
Shanghai, Shanghai, China, 200000 | |
Contact: Liang Chen, Doctor 00862137990333 chenlian@shaphl.org |
Principal Investigator: | Liang Chen | Public Health Clinical Center Affiliated to Fudan University |
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 |
Hepatitis B Cholestasis |
Hepatitis A Hepatitis B Hepatitis B, Chronic Hepatitis Cholestasis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections |
Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Hepadnaviridae Infections DNA Virus Infections Hepatitis, Chronic Bile Duct Diseases Biliary Tract Diseases |