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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031239
Receipt No. R000035667
Scientific Title Investigation of the efficacy and safety of ledipasvir and sofosbuvir therapy for Genotype 1 Hepatitis C Virus infection in patients with decompensated cirrhosis
Date of disclosure of the study information 2018/05/01
Last modified on 2021/02/11

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Basic information
Public title Investigation of the efficacy and safety of ledipasvir and sofosbuvir therapy for Genotype 1 Hepatitis C Virus infection in patients with decompensated cirrhosis
Acronym LDF/SOF for decompensated cirrhosis
Scientific Title Investigation of the efficacy and safety of ledipasvir and sofosbuvir therapy for Genotype 1 Hepatitis C Virus infection in patients with decompensated cirrhosis
Scientific Title:Acronym LDF/SOF for decompensated cirrhosis
Region
Japan

Condition
Condition Decompensated cirrhosis by Genotype 1 Hepatitis C Virus infection
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of the efficacy and safety of ledipasvir and sofosbuvir therapy for Genotype 1 Hepatitis C Virus infection in patients with decompensated cirrhosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serious adverse events occurrence rate
Key secondary outcomes sustained virological response

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Ledipasvir(90mg)/sofosbuvir(400mg) for 12 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender 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 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)Others judged as being inappropriate for the subjects of the study by investigators.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Tetsuo
Middle name
Last name Takehara
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 5650871
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3621
Email takehara@gh.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Ryotaro
Middle name
Last name Sakamori
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 5650871
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3621
Homepage URL
Email sakamori@gh.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka University Graduate School of Medicine
Funding from patient
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka University Clinical Research Review Committee
Address 2-2 Yamadaoka, Suita, Osaka, Japan
Tel 06-6210-8296
Email rinri@hp-crc.med.osaka-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 01 Day

Related information
URL releasing protocol https://jrct.niph.go.jp/latest-detail/jRCTs051180003
Publication of results Published

Result
URL related to results and publications https://jrct.niph.go.jp/latest-detail/jRCTs051180003
Number of participants that the trial has enrolled 1
Results 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
2020 Year 08 Month 12 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2021 Year 03 Month 01 Day
Baseline Characteristics Decompensated cirrhosis by Genotype 1 Hepatitis C Virus infection
(one patient enrolled, 76 years old female)
Participant flow 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.
Adverse events 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.
Outcome measures 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

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 02 Month 13 Day
Date of IRB
2018 Year 06 Month 06 Day
Anticipated trial start date
2018 Year 08 Month 07 Day
Last follow-up date
2019 Year 07 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 09 Day
Last modified on
2021 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035667

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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