UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000176 |
|---|---|
| Receipt number | R000000249 |
| Scientific Title | Randomized, double-blind, placebo-controlled trial of orally administered bovine lactoferrin in patients with chronic hepatitis C |
| Date of disclosure of the study information | 2005/10/01 |
| Last modified on | 2007/04/05 11:31:58 |
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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
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
hiueno@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital, Hepatobiliary and Pancreatic Oncology Division
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000249
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