||Male and Female
|Key inclusion 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
|Key exclusion criteria
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
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)Others judged as being inappropriate for the subjects of the study by investigators.
|Target sample size
|URL related to results and publications
|Number of participants that the trial has enrolled
||One patient was enrolled, and protocol treatment was completed in one case. Therefore, the number of cases subject to the primary efficacy endpoint (all treatments) and the secondary endpoint (all eligible cases) was one.
|Results date posted
|Results Delay Reason
|Date of the first journal publication of results
||Decompensated cirrhosis by Genotype 1 Hepatitis C Virus infection
(one patient enrolled, 76 years old female)
||The elimination rate of hepatitis C virus at 12 weeks after the end of treatment (Day 169), which is the primary endpoint of efficacy, was 100% (1 of 1 case), and the primary endpoint of efficacy was achieved. Hepatitis C virus elimination was obtained 12 weeks after the end of treatment (Day 169), and viral elimination was continuously obtained 24 weeks after the end of treatment. Regarding the secondary efficacy endpoint, the Child-Pugh score improved from B (7 points) to A (6 points), improving the liver function indicated by Child-Pugh score, while no significant change of MELD score was observed until 12 weeks after completion. An increase in MELD score was observed 24 weeks after the end of treatment, but this was accompanied by a temporary increase in creatinine, and it was judged that hepatic function was not deteriorated. Based on the above, it is judged comprehensively that liver function has improved. The carcinogenic inhibitory effect was not judged because it was a single case, but in this case, no liver carcinogenesis was observed within the observation period, and a decrease in PIVKA-II, a tumor marker for liver cancer, was observed. There was a possibility that liver fibrosis markers decreased at the time of subsequent observation compared with the start of treatment in all 4 factors, and the possibility of improvement in fibrosis was obtained. From the above, it is considered that the effectiveness was recognized although it was an evaluation in one example.
||The primary safety endpoint, rate of serious adverse events caused by this study drug from the start of treatment to 12 weeks after the end of treatment was 0% (0 of 1 case).
Regarding adverse events, a secondary endpoint of safety, Shortness of breath (exertional dyspnea) was observed, but it was non-serious and considered not to have a direct causal relationship to the study drug. Other safety secondary endpoints: early death rate was 0% (0 cases), treatment-related death rate was 0% (0 cases), protocol treatment completion rate was 100% (1 of 1 case) and it was judged that safety of this study was shown although it was an evaluation in only 1 case.
||In this study, Epcrusa combination tablet (Sofosbuvir / Velpatasvir combination tablet) was approved for hepatitis C decompensated cirrhosis after the start of the study, so this study was discontinued in 1 patient enrolled. Although the protocol treatment was completed in one case, it was considered that efficacy and safety were confirmed by confirming the primary and secondary endpoints of efficacy and safety.
|Plan to share IPD
|IPD sharing Plan description