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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000024261 |
Receipt No. | R000027843 |
Scientific Title | Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients |
Date of disclosure of the study information | 2016/10/03 |
Last modified on | 2018/03/05 |
Basic information | ||
Public title | Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients | |
Acronym | Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients | |
Scientific Title | Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients | |
Scientific Title:Acronym | Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients | |
Region |
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Condition | ||
Condition | genotype 1 HCV patients receiving hemodialysis | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | we aim at examining the effect on iron and mineral-bone metabolism after HCV clearance by daclatasvir and asunaprevir combination therapy in genotype 1 HCV-infected hemodialysis patients |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | To compare erythropoietic resistance index change between pre and post of treatment in the early intervention group and waiting intervention group |
Key secondary outcomes | To assess Iron metabolism kinetics
To assess mineral-bone metabolism kinetics To assess antiviral activity, the proportion of subjects who achieve undetectable HCV RNA at post treatment week 12 To assess safety To assess CLDQ-HCV, KDQOL-SF |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | No treatment |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | The subjects will be randomly assigned to the early intervention group and waiting intervention group. After entry in the study, the early intervention group will orally receive ASV 100 mg per dose twice daily and DCV 60 mg once daily for 24 weeks. After this treatment, the subjects will be observed for a further 24 week period. | |
Interventions/Control_2 | The waiting intervention group will wait for the first 24 weeks and then receive the ASV/DCV combination therapy. | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)20 years old or older
2)Genotype 1 HCV -infected patients receiving hemodialysis 3)Patients who were provided with sufficient explanation before participating in this study and who provided written consent to participate in this study on their own free will. |
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Key exclusion criteria | 1)Patients with decompensated cirrhosis
2)Patients complicated with hepatic cancer 3)Other patients whom the chief investigator or a sub-investigators considers inappropriate |
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Target sample size | 120 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Tokai University School of Medicine | ||||||
Division name | Department of Gastroenterology and Hepatology | ||||||
Zip code | |||||||
Address | shimokasuya 143, Isehara, Kanagawa, Japan | ||||||
TEL | 0463-93-1121 | ||||||
arase@tokai-u.jp |
Public contact | |||||||
Name of contact person |
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Organization | Tokai University Oiso Hospital | ||||||
Division name | Department of Gastroenterology and Hepatology | ||||||
Zip code | |||||||
Address | Gakkyo 21-1, Oisotyo, Nakagun, Kanagawa, Japan | ||||||
TEL | 0463-72-3211 | ||||||
Homepage URL | |||||||
arase@tokai-u.jp |
Sponsor | |
Institute | Department of Gastroenterology and Hepatology, Tokai University School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | Bristol-Myers Squibb |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
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IRB Contact (For public release) | |
Organization | |
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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 | 東海大学医学部付属病院
東海大学医学部付属大磯病院 東海大学医学部付属八王子病院 東海大学医学部付属東京病院 帝京大学医学部付属病院 順天堂大学医学部付属順天堂医院 順天堂大学医学部付属練馬病院 医療法人社団 松和会 池上総合病院 |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
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Results Delayed | |
Results Delay Reason | |
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Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027843 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
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