![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
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 |
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 |
|
Condition | ||
Condition | Chronic hepatitis type C, cirrhosis type C | |
Classification by specialty |
|
|
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
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 |
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 |
|
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 |
|
||||||
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
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 |