UMIN-CTR Clinical Trial

Basic information
Public title	Randomized, double-blind, placebo-controlled trial of orally administered bovine lactoferrin in patients with chronic hepatitis C
Acronym	Randomized trial of lactoferrin for chronic hepatitis C
Scientific Title	Randomized, double-blind, placebo-controlled trial of orally administered bovine lactoferrin in patients with chronic hepatitis C
Scientific Title:Acronym	Randomized trial of lactoferrin for chronic hepatitis C
Region	Japan

Condition
Condition	Chronic hepatitis C
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the anti-HCV activity of lactoferrin for chronic hepatitis C
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Virologic response, defined as a 50% or greater decrease in the serum HCV RNA level at 12 weeks compared with the baseline
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Lactoferrin
Interventions/Control_2	Placebo
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	74 years-old >=
Gender	Male and Female
Key inclusion criteria	1)20-74 years of age, 2)Positivity for anti-HCV antibody, 3)An HCV RNA level evaluated within 1 month before entry of 0.5-850 KIU/mL, 4)A sustained elevation of serum ALT levels (more than the upper normal limit) for at least 6 months, 5)A serum ALT level evaluated within 1 month before entry of >=twice the upper normal limit, 6)No evidence of HCC on the basis of ultrasonography or computed tomography performed within 3 months before entry, 7)Adequate bone marrow function [white blood cell count >=4000/mm3, platelet count >=100,000/mm3, and hemoglobin level >=11 g/dL], liver function [total bilirubin level <=2.0 mg/dL, serum albumin level >=3.5 g/dL, and serum AST and ALT levels <=200 IU/L], and renal function [normal serum creatinine and blood urea nitrogen levels], 8)Written informed consent
Key exclusion criteria	1) Positivity for hepatitis B surface antigen, 2) Interferon therapy within 6 months before entry; immunomodulatory or corticosteroid therapy within 3 months before entry; intravenous glycyrrhizin therapy within 1 month before entry, 3) Past or present history of bovine lactoferrin tablets intake, 4) Severe hepatic disease (e.g. autoimmune hepatitis and primary biliary cirrhosis), 5) Other serious medical conditions (e.g. gastrointestinal bleeding, active infection, severe pulmonary disease, and psychiatric disorders), 6) Pregnant or lactating females
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takuji Okusaka, MD, PhD
Organization	National Cancer Center Hospital
Division name	Hepatobiliary and Pancreatic Oncology Division
Zip code
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL	03-3542-2511
Email

Public contact
Name of contact person	1st name Middle name Last name Hideki Ueno, MD
Organization	Lactoferrin Coordinating Office
Division name	National Cancer Center Hospital, Hepatobiliary and Pancreatic Oncology Division
Zip code
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL	03-3542-2511
Homepage URL
Email	hiueno@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital, Hepatobiliary and Pancreatic Oncology Division
Institute
Department

Funding Source
Organization	Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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	2005 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	http://www.blackwell-synergy.com/doi/full/10.1111/j.1349-7006.2006.00274.x
Number of participants that the trial has enrolled
Results	One hundred ninety-eight of 199 patients were evaluable for efficacy and safety. bLF treatment was well tolerated and no serious toxicities were observed. A virologic response was achieved in 14 of 97 patients (14.4%) in the bLF group, and 19 of 101 (18.8%) in the placebo group. There was no significant difference in virologic response rates between the two groups (-4.4%, 95% confidence interval -14.8 to 6.1). In addition, bLF intake did not have any favorable effect on the serum ALT level. The virologic responses were not different between two groups in any subgroup analysis. In conclusion, orally administered bLF does not demonstrate any significant efficacy in patients with chronic hepatitis C. Ueno H, et al: Randomized, double-blind, placebo-controlled trial of bovine lactoferrin in patients with chronic hepatitis C. Cancer Science 2006;97:1105-1110.
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	2001 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date	2001 Year 05 Month 01 Day
Last follow-up date	2005 Year 03 Month 01 Day
Date of closure to data entry	2005 Year 03 Month 01 Day
Date trial data considered complete	2005 Year 06 Month 01 Day
Date analysis concluded	2005 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date	2005 Year 09 Month 12 Day
Last modified on	2007 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000249

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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