UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000026079
Receipt No. R000029848
Scientific Title Supportive effect of carnitine on hepatitis C virus eradication therapy
Date of disclosure of the study information 2017/02/10
Last modified on 2020/08/17 (Ver. 4)

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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/icdr_e/ctr_view.cgi?recptno=R000029848