LDF/SOF for decompensated cirrhosis

JRCT ID: jRCTs051180003

Registered date:07/08/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Decompensated cirrhosis by Genotype 1 Hepatitis C Virus infection
• Date of first enrollment: 24/10/2018
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Anti-viral therapy

Outcome(s)

• Primary Outcome: Serious adverse events occurrence rate,sustained virological response(SVR12)
• Secondary Outcome: Adverse events rate,Early mortality rate,Treatment-related death occurrence rate,Liver faunction improvement,Anti-carcinogenic effect,sustained virological response(SVR24)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
1)CPT class B or C cirrhosis with chronic infection of HCV genotype 1
2)Age > 20 years at screening
3)Performance status (ECOG) 0, 1 or 2
4)eGFR > 30 mL/min/1.73m2
5)Able to understand and sign the Informed Consent Document

Exclude criteria

1)
a)Clinically significant illness or currently under evaluation for a potentially clinically significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
b)Gastrointestinal disorder or postoperative condition that could interferer with the absorption of the study drugs
c)Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
d)Significant pulmonary disease
e)Unstable cardiac disease or significant cardiac event within one year prior to Screening
f)Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 2 years prior to Screening
g)Significant drug allergy
h)Hepatopulmonary syndrome
i)Hepatorenal syndrome
2)Screening ECG with clinically significant abnormalities
3)Pregnant or nursing female or male with pregnant female partner
4)Women who wish to become pregnant or males with female partners who wish to become pregnant during study treatment or 30 days after the last dose LDV/SOF
5)Active spontaneous bacterial peritonitis at Screening
6)Evidence of fibrosing cholestatic hepatitis
7)Life threatening SAE during Screening
8)Active variceal bleeding within 6 months of Screening
9)Subjects with any of the following laboratory parameters at Screening:
a)Hemoglobin (Hb) < 10g/dL
b)Platelets < 50000/mm3
c)Neutrophils < 1000/mm3
d)ALT, AST, or alkaline phosphatase > 10 x ULN
e)Sodium < 125 mEq/L
f)Total bilirubin > 10 mg/dL
g)eGFR < 30 ml/min/1.73m2
10)Donation or loss of more than 400mL o blood within 2 months prior to Day 1
11)Any prohibited medications as described below
Carbamazepine, Phenytoin, Rifampicin, St John Wort
12)Known hypersensitivity to ledipasvir, sofosbuvir, or the metabolities or formulation excipients
13)After failure of interferon free therapy
14)Others judged as being inappropriate for the subjects of the study by investigators.

Related Information

• Primary Sponsor: Takehara Tetsuo
• Source(s) of Monetary Support: Funding from patient
• Secondary ID(s): UMIN000031239