UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026079 |
|---|---|
| Receipt number | 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 08:17:59 |
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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
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
moriyak@naramed-u.ac.jp
Sponsor or person
Institute
Third department of Internal Medicine, Nara Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029848
