UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009656 |
|---|---|
| Receipt number | 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 13:15:23 |
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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
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
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011283
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