UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009656
Receipt No. R000011283
Scientific Title Therapeutic drug monitoring of telaprevir in chronic hepatitis C patients receiving telaprevir -based triple therapy is useful for predicting virological response.
Date of disclosure of the study information 2012/12/28
Last modified on 2012/12/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Therapeutic drug monitoring of telaprevir in chronic hepatitis C patients receiving telaprevir -based triple therapy is useful for predicting virological response.
Acronym Plasma telaprevir concentrations in chronic hepatitis C patients receiving telaprevir -based triple therapy
Scientific Title Therapeutic drug monitoring of telaprevir in chronic hepatitis C patients receiving telaprevir -based triple therapy is useful for predicting virological response.
Scientific Title:Acronym Plasma telaprevir concentrations in chronic hepatitis C patients receiving telaprevir -based triple therapy
Region
Japan

Condition
Condition Chronic hepatitis C patients of genotype 1
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This pharmacokinetic study was done to investigate the impact of telaprevir (TVR) plasma trough concentrations (C-trough) on the response of TVR-based triple therapy in chronic hepatitis C patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To investigate the impact of telaprevir (TVR) plasma trough concentrations (C-trough) on the response of TVR-based triple therapy in chronic hepatitis C patients
Key secondary outcomes

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 Patients receive 12-week triple therapy that included TVR (2250mg/day), pegylated interferon alpha-2b (PEG-IFN alpha2b) (60-150micro-g/week) and ribavirin (RBV) (600-1000mg/day) followed by a 12-week dual therapy that included PEG-IFN alpha2b and RBV.
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 patients with chronic hepatitis C patients of genotype 1
Key exclusion criteria Exclusion criteria were: (1) positivity for antibody to human immunodeficiency virus or positivity for hepatitis B surface antigen; (2) clinical or biochemical evidence of hepatic decompensation (ascites, bleeding varices, or encephalopathy); (3) other causes of liver disease (autoimmune hepatitis, primary biliary cirrhosis, or steatohepatitis); (4) excessive active alcohol consumption (a daily intake of more than 40 g of ethanol) or drug abuse; (5) suspected HCC at entry; or (6) treatment with antiviral or immunosuppressive agents prior to enrollment.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Furusyo
Organization Kyushu University Hospital
Division name Department of General Internal Medicine
Zip code
Address 3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582, Japan
TEL 092-642-5909
Email

Public contact
Name of contact person
1st name
Middle name
Last name Norihiro Furusyo
Organization Kyushu University Hospital
Division name Department of General Internal Medicine
Zip code
Address 3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582, Japan
TEL 092-642-5909
Homepage URL
Email

Sponsor
Institute Kyushu University Hospital
Institute
Department

Funding Source
Organization Kyushu University Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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 九州大学病院 Kyushu University Hospital

Other administrative information
Date of disclosure of the study information
2012 Year 12 Month 28 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The rates of undetectable HCV RNA at week 4 (RVR) and at 24 weeks after therapy (sustained virological response: SVR) were 71.4% and 82.9%, respectively. Of patients with RVR, 90% achieved an SVR. The mean TVR C-troughs at days 3 and 7 and weeks 2 and 8 of SVR patients (2748.2, 2733.7, 2999.0, and 2937.8 ng/mL, respectively) was significantly higher than that of non-SVR patients (1616.4, 1788.0, 2314.4, and 2691.1 ng/mL, respectively) (all P<0.05). Multiple logistic regression analysis identified two factors: higher TVR C-trough at day 3 (ng/mL) (odds ratio 1.012, P<0.0001) and prior treatment relapse (odds ratio 6.16 for prior null response, P<0.0001).
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
2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2012 Year 12 Month 28 Day
Date of closure to data entry
2012 Year 12 Month 28 Day
Date trial data considered complete
2012 Year 12 Month 28 Day
Date analysis concluded
2012 Year 12 Month 28 Day

Other
Other related information Therapeutic drug monitoring of TVR in patients receiving TVR-based triple therapy is useful in clinical practice for predicting virological response.

Management information
Registered date
2012 Year 12 Month 28 Day
Last modified on
2012 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011283

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.