UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020302 |
|---|---|
| Receipt number | R000023442 |
| Scientific Title | Efficacy and Safety of Ombitasvir plus Paritaprevir/r combination regimen for Hepatitis C infected patients with immune disorders |
| Date of disclosure of the study information | 2015/12/24 |
| Last modified on | 2020/01/07 18:18:57 |
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Basic information
Public title
Efficacy and Safety of Ombitasvir plus Paritaprevir/r combination regimen for Hepatitis C infected patients with immune disorders
Acronym
Ombitasvir /Paritaprevir/r therapy for patients with immune disorders
Scientific Title
Efficacy and Safety of Ombitasvir plus Paritaprevir/r combination regimen for Hepatitis C infected patients with immune disorders
Scientific Title:Acronym
Ombitasvir /Paritaprevir/r therapy for patients with immune disorders
Region
| Japan |
Condition
Condition
Patients with genotype 1 HCV infection who have immune disorder
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy (SVR12 rate) and safety of Ombitasvir / Paritaprevir/rtherapy in CHC patients with immune disorders (cryoglobulinemia or Sjogrens syndrome)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate efficacy (SVR12 rate) and safety of Ombitasvir / Paritaprevir/r therapy in CHC patients with immune disorders (cryoglobulinemia or Sjogrens syndrome)
Key secondary outcomes
To assess the effect of HCV treatment on the status of immune disorders (cryoglobulinemia or Sjogrens syndrome).
2)mutations as viral factors on virologic response
3) Rate of emergence of drug-resistant variants
4) Presence or absence of a reversal of liver fibrosis
5) Presence or absence of an improvement in AFP levels
6) Effects of glucose/lipid-related factors on treatment response
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Patients (1) with the target disease who (2) satisfy all the inclusion criteria and (3) meet none of the exclusion criteria are eligible for the study.
(1) Subjects
Patients with immune disorder, who have a chronic HCV infection and compensated cirrhosis
(2) Inclusion criteria
[1] Patients who are 20 years of age or older at the time of informed consent
[2] Patients who have been fully informed and have provided written informed consent to participate in this study prior to study initiation
[3] Patients with a chronic HCV genotype 1 infection and compensated cirrhosis who do not meet any of the following exclusion criteria
Key exclusion criteria
1) Patients with poorly controlled cardiac disease (e.g., myocardial infarction, cardiac failure, arrhythmia)
2) Patients with severe hepatic impairment
3) Patients with a history of hypersensitivity to HCV protease inhibitors or NS5A inhibitor
4) Patients with a concurrent malignancy, including hepatocellular carcinoma, at the start of treatment
5) Patients deemed unsuitable for study entry by their treating physician
6) Patients who are unsuitable, in the opinion of the principal investigator, for this study due to any other reason
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Goki Suda |
Organization
Hokkaido University
Division name
Department of Gastroenterology and Hepatology, Graduate School of Medicine,
Zip code
Address
Kita 14-jo Nishi 5-jo, Kita-ku, Sapporo city, Hokkaid
TEL
+81-11-716-1161
gsudgast@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Goki Suda |
Organization
Hokkaido University
Division name
Department of Gastroenterology and Hepatology, Graduate School of Medicine,
Zip code
Address
Kita 14-jo Nishi 5-jo, Kita-ku, Sapporo city, Hokkaid
TEL
+81-11-716-1161
Homepage URL
gsudgast@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
AbbVie GK
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 24 | Day |
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
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is cohort study
Way for subscription
Patients who visit our hospital between November 2015 and march 2017, and meet inclusion criteria are enrolled.
Management information
Registered date
| 2015 | Year | 12 | Month | 21 | Day |
Last modified on
| 2020 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023442
