臨床研究等提出・公開システム

Date of registration	April. 05, 2010
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221056

Scientific Title	PhaseI study with multiple, ascending doses of NA808 in patients with chronic hepatitis C viral infection.
Public Title	NA808 PhaseI multiple ascending doses study

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Chugai Pharmaceutical Co., Ltd.
	Address	clinical-trials@chugai-pharm.co.jp
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Chugai Pharmaceutical Co., Ltd.
	Address	clinical-trials@chugai-pharm.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		20
Study Type		Interventional
Study Design	Study Design	Open-label, multicenter study
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	Subject shows detectable HCV RNA and has no clinically significant disorders. Male or female of no child-bearing potential
	Exclusion Criteria
	Minimum Age	20age old over
	Maximum Age	70age old under
	Gender	Both
Health Condition or Problem Studied		Patients with chronic hepatitis C viral infection
Intervention(s)		investigational material(s) Generic name etc : NA808 INN of investigational material : Therapeutic category code : 639 Other biological preparations Dosage and Administration for Investigational material : Multiple intravenous administration (100 mg,200 mg or 400 mg per week) control material(s) Generic name etc : non INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : non
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Safety Pharmacokinetics HCV-RNA viral kinetics
Secondary Outcome		non

Primary Sponsor	Chugai Pharmaceutical Co., Ltd.
Secondary Sponsor	non

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-101089
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
10	Dec. 17, 2018	(this page)	Changes
9	Feb. 03, 2011	Detail	Changes
8	Feb. 03, 2011	Detail	Changes
7	Aug. 31, 2010	Detail	Changes
6	Aug. 31, 2010	Detail	Changes
5	April. 12, 2010	Detail	Changes
4	April. 12, 2010	Detail	Changes
3	April. 05, 2010	Detail	Changes
2	April. 05, 2010	Detail	Changes
1	April. 05, 2010	Detail

List of change history