---
title: Efficacy and Safety of S-adenosyl-l-methionine in Treatment of Alcoholic Hepatitis With Cholestasis
nct_id: NCT02024295
overall_status: UNKNOWN
phase: PHASE4
sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.
study_type: INTERVENTIONAL
primary_condition: Hepatitis, Alcoholic
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02024295.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02024295"
ct_last_update_post_date: 2014-05-29
last_seen_at: "2026-05-12T07:13:15.284Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy and Safety of S-adenosyl-l-methionine in Treatment of Alcoholic Hepatitis With Cholestasis

**NCT ID:** [NCT02024295](https://clinicaltrials.gov/study/NCT02024295)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 118
- **Lead Sponsor:** Zhejiang Hisun Pharmaceutical Co. Ltd.
- **Conditions:** Hepatitis, Alcoholic
- **Start Date:** 2013-12
- **Completion Date:** 2015-12
- **CT.gov Last Update:** 2014-05-29

## Brief Summary

To determine the efficacy and safety S-adenosyl-l-methionine in alcoholic hepatitis with cholestasis.

## Detailed Description

randomize first time for core treatment stage for 6 weeks, then randomized second time for extend treatment for 42 weeks.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 90 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Body Mass Index range 19-30kg/m2
* Alcohol Drinking history more than 5 years, for male ≥ 40g/ day, for female ≥ 20g/ day;
* STB from 2 to 10X ULN;
* ALP\>1.5X ULN or GGT\>3X ULN

Exclusion Criteria: any one of below,

* active virus hepatitis, or anti-HIV(+)
* exclude other hepatic disease: non-alcoholic fatty liver, drug-induced liver injury, autoimmune hepatitis( AMA/ANA\>1:100), Wilson disease, hemochromatosis or other hepatic disease; obstructive cholestasis
* other non-hepatic diseases caused jaundice
* primary hepatic carcinoma
```

## Arms

- **Ademethionine** (EXPERIMENTAL) — ademethionine 1000mg ivgtt qd for 2 weeks, then orally 1000mg bid for 4 weeks.
- **Polyene Phosphatidyl choline** (ACTIVE_COMPARATOR) — Polyene Phosphatidyl choline 10ml ivgtt qd for 2 weeks, then Polyene Phosphatidyl choline 456 mg tid orally for 4 weeks.

## Interventions

- **Ademethionine** (DRUG) — ademethionine 1000mg ivgtt qd for 2 weeks, then orally 1000mg bid for 4 weeks.
- **Polyene Phosphatidyl choline** (DRUG) — Polyene Phosphatidyl choline 10ml ivgtt qd for 2 weeks, then Polyene Phosphatidyl choline 456 mg tid orally for 4 weeks.
- **Ademethionine** (DRUG) — after 6 weeks of core treatment stage, then ademethionine 1000mg bid or qd orally for 42 weeks

## Primary Outcomes

- **response rate of serum total bilirubin** _(time frame: 6 weeks)_ — response rate means percentage of subjects whose serum total bilirubin values declined from baseline over 30%

## Secondary Outcomes

- **level of serum direct bilirubin** _(time frame: 6 weeks and 48 weeks)_
- **level of serum bile acids** _(time frame: 6 weeks and 48 weeks)_
- **level of glutamic pyruvic transaminase** _(time frame: 6 weeks and 48 weeks)_
- **level of glutamic oxaloacetic transaminase** _(time frame: 6 weeks and 48 weeks)_
- **level of alkaline phosphatase** _(time frame: 6 weeks and 48 weeks)_
- **level of gamma-glutamyl transpeptidase** _(time frame: 6 weeks and 48 weeks)_
- **level of hyaluronic acid** _(time frame: 6 weeks and 48 weeks)_

## Locations (2)

- Beijing Ditan Hospital, Beijing, Beijing Municipality, China — _RECRUITING_
- Jun Cheng, Beijing, Beijing Municipality, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.beijing ditan hospital|beijing|beijing municipality|china` — added _(2026-05-12)_
- `locations.jun cheng|beijing|beijing municipality|china` — added _(2026-05-12)_

---

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