UMIN-CTR Clinical Trial

Basic information
Public title	Supportive effect of carnitine on hepatitis C virus eradication therapy
Acronym	Supportive effect of carnitine on HCV eradication
Scientific Title	Supportive effect of carnitine on hepatitis C virus eradication therapy
Scientific Title:Acronym	Supportive effect of carnitine on HCV eradication
Region	Japan

Condition
Condition	Chronic hepatitis type C, cirrhosis type C
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the supportive effect of carnitine on hemolytic anemia induced by ribavilin
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The degree of anemia progression at the end of anti-viral treatment
Key secondary outcomes	Sustained viral response (SVR) at 24 weeks

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	carnitine
Interventions/Control_2	control
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	1)Patients over 20 years old 2)Chronic hepatitis type C or cirrhosis type C 3)HCV-RNA positive and HCV genotype 2 4)Patients obtained written informed consent 5)Carnitine <=91mmol/L
Key exclusion criteria	1)Patients with oral intake difficulty 2)Patients with severe digestive disease 3)Pregnant woman, lactating woman, or a woman suspected of pregnancy 4)Patients with severe allergic reaction 5)Patients with drug abuse or psycological disorders 6)Carnitine >=92mmol/L
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kei Middle name Last name Moriya
Organization	Nara Medical University
Division name	Third department of Internal Medicine
Zip code	6348522
Address	840 Shijo-cho, Kashihara, Nara, JAPAN
TEL	0744-22-3051
Email	moriyak@naramed-u.ac.jp

Public contact
Name of contact person	1st name KEI Middle name Last name MORIYA
Organization	Nara Medical University
Division name	Third department of Internal Medicine
Zip code	6348522
Address	840 Shijo-cho, Kashihara, Nara, JAPAN
TEL	0744-22-3051
Homepage URL
Email	moriyak@naramed-u.ac.jp

Sponsor
Institute	Third department of Internal Medicine, Nara Medical University
Institute
Department

Funding Source
Organization	None
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	Clinical Research Center, Nara Medical University
Address	840 Shijo, Kashihara, Nara, JAPAN
Tel	0744223051
Email	icats@naramed-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	奈良県立医科大学付属病院

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 10 Day

Related information
URL releasing protocol	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6435976/pdf/cmh-2018-0070.pdf
Publication of results	Published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6435976/pdf/cmh-2018-0070.pdf
Number of participants that the trial has enrolled	44
Results	A significantly smaller decrease in hemoglobin concentration was observed in group B (treated with sofosbuvir, ribavirin, and L-carnitine) compared to group A (treated with sofosbuvir plus ribavirin for 3 months) at every time point. Moreover, the prescribed dose intensity of ribavirin in group B was higher than that of group A, resulting in a higher ratio of sustained virological response (SVR) 24 in group B compared with group A.
Results date posted	2020 Year 08 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Patients with HCV
Participant flow	The envelope method was used in this study. Each patient chose one of the two envelopes and was enrolled into the group being described.
Adverse events	None
Outcome measures	Degree of hemolytic anemia
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 17 Day
Date of IRB	2015 Year 06 Month 30 Day
Anticipated trial start date	2015 Year 08 Month 15 Day
Last follow-up date	2016 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 02 Month 10 Day
Last modified on	2020 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029848

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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