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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000176 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Chronic hepatitis C | |
Classification by specialty |
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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 |
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Interventions/Control_1 | Lactoferrin | |
Interventions/Control_2 | Placebo | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
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Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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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 | |
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 | |
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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 |
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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 | |
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Baseline Characteristics | |
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Recruitment status | Completed | ||||||
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Last modified on |
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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 |