UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective multicenter study for characterization of renal function G1b CHC patients with CKD-3 treated with elbasvir plus grazoprevir
Title of the study (Brief title)	Elbasvir plus grazoprevir treatment for patients with G1b CHC patients with CKD-3
Region	Japan

Condition
Condition	Genotype 1b chrinic hepatitis C patients with CKD-3
Classification by specialty	Hepato-biliary-pancreatic medicine Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of elbasvir plus grazoprevir in patients infected with HCV genotype 1b.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of sustained viral response.
Key secondary outcomes	(1)Transition of renal function (2)Safety(the rate of discontinuation) (3)Biochemical efficacy

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Treatment of elbasvir plus grazoprevir
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	1.Patients who are infected with HCV genotype 1b 2.Patients with moderate chronic kidney disease (CKD stage 3)
Key exclusion criteria	1.Decompensated liver cirrhosis (Child Pugh B/C) 2.Patients with co-infection with HBV or HIV 3.Patients who are pregnant females, or females who may become pregnant 4.Patients who are under medication with drugs listed as contraindication in a package insert 5.Patients judged to be inappropriate as subjects for the study
Target sample size	80

Research contact person
Name of lead principal investigator	Norihiro Furusyo
Organization	Kyushu University Hospital
Division name	Department of General Internal Medicine
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL	092-642-5909
Email	furusyo@gim.med.kyushu-u.ac.jp

Public contact
Name of contact person	Eiichi Ogawa
Organization	Kyushu University Hospital
Division name	Department of General Internal Medicine
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL	092-642-5909
Homepage URL
Email	eogawa@gim.med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University
Institute
Department

Funding Source
Organization	MSD K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 03 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 30 Day
Anticipated trial start date	2017 Year 03 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 08 Month 15 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	The overall sustained viral response (SVR) rates in the per protocol populations were 98.7% (76/77). High SVR12 rates were observed in almost all subgroups, including older age (over 75 years), cirrhosis, and history of HCC. There was no significant change during treatment or follow-up period in estimated glomerular filtration rate and endostatin level. In contrast, the serum complement level (C3 and C4) increased, with significance for C3. Serious adverse effects were very rare, and discontinuation was required for only two (2.5%) patients due to the ALT elevation during the second half of treatment.
Other related information	We published the real-world cohort study consisted of 282 Japanese patients who were treated with elbasvir plus grazoprevir, including the data of 80 patients with CKD stage 3.

Management information
Registered date	2017 Year 03 Month 14 Day
Last modified on	2019 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030481