OP-724-002 study
Phase 2
Recruiting
- Conditions
- Decompensated cirrhosis related with HCV, HBV or NASHDecompensated cirrhosis, HCV, HBV, NASHD008103
- Registration Number
- JPRN-jRCT2031230195
- Lead Sponsor
- Haruyama Yuushi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 93
Inclusion Criteria
1. Patients with decompansated cirrhosis (Child-Pugh class B: Score 7-9)
2. Patients with liver cirrhosis related with HCV, HBV, or NASH
3. Patients with performance Status: 0-2
4. Patients with serum albumin levels =<3.5 g/d
Exclusion Criteria
1. Patients with decompansated cirrhosis of which cause is unknown
2. Patients with refractory ascites
3. Patients with complication or history of malignant tumor (within 3 years before screening, excepting the patients with no relapse of hepatocellular carcinoma during more than 1 year from surgical treatment etc.)
4. Patients with or have a history of serious allergies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Child-Pugh score
- Secondary Outcome Measures
Name Time Method Child-Pugh score, ALBI score, Liver stiffness, Serum fibrosis markers, etc.