UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020302
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email gsudgast@pop.med.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023442

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.