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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The regimen using grazoprevir plus elbasvir treatment is promising in Japan, because it may safely be used for the elderly patients with renal dysfunction. Grazoprevir and elbasvir are metabolized in the liver and do not require dose-adjustment for patients with renal dysfunction. However, no data related to efficacy and safety of the grazoprevir plus elbasvir treatment for Japanese elderly patients with renal dysfunction (eGFR<60 mL/min/1.73m2) have been reported. Therefore, physicians are at a loss whether or not to treat the patients with renal dysfunction due to no evidence.
The aim of this study is to investigate the improvement of serum endostatin level of Japanese patients with CKD stage 3 after grazoprevir (NS3/4A protease inhibitor) plus elbasvir (NS5A replication complex inhibitor) treatment by a prospective, multicenter cohort study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grazoprevir plus Elbasvir | Experimental | Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grazoprevir plus Elbasvir | Drug | An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Serum Endostatin Level (ng/mL) From Baseline to 3 Months | We evaluated the serum endostatin at baseline and 3 months after the treatment initiation. | 3 months |
| Change of eGFR Level (mL/Min/1.73m^2) From Baseline to 3 Months | We evaluated eGFR level at baseline and 3 months after the treatment initiation. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Virological Response-12 (SVR12) | SVR12 was defined as undetectable HCV RNA at week 12 after the end of treatment. | 3 months |
| Change of Serum Alanine Aminotransferase (ALT) Level (U/L) From Baseline to 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norihiro Furusyo, MD, PhD | Kyushu University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyushu University Hospital | Fukuoka | 812-8582 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23542346 | Background | Furusyo N, Ogawa E, Nakamuta M, Kajiwara E, Nomura H, Dohmen K, Takahashi K, Satoh T, Azuma K, Kawano A, Tanabe Y, Kotoh K, Shimoda S, Hayashi J; Kyushu University Liver Disease Study (KULDS) Group. Telaprevir can be successfully and safely used to treat older patients with genotype 1b chronic hepatitis C. J Hepatol. 2013 Aug;59(2):205-12. doi: 10.1016/j.jhep.2013.03.020. Epub 2013 Mar 28. | |
| 27142311 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Grazoprevir Plus Elbasvir | Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks. Grazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Grazoprevir Plus Elbasvir | Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks. Grazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of Serum Endostatin Level (ng/mL) From Baseline to 3 Months | We evaluated the serum endostatin at baseline and 3 months after the treatment initiation. | Posted | Mean | Standard Deviation | ng/mL | 3 months |
|
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Grazoprevir Plus Elbasvir | Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks. Grazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious ALT elevation | Hepatobiliary disorders | Non-systematic Assessment | ALT>300 U/L during treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eiichi Ogawa / Assistant Professor | Kyushu University Hospital | 81926425909 | eogawa@gim.med.kyushu-u.ac.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2018 | Feb 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C578009 | grazoprevir |
| C000589335 | elbasvir |
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We evaluated the serum ALT levels at baseline and 3 months after the treatment initiation.
| 3 months |
| Change of Serum Alpha-fetoprotein Level (ng/mL) From Baseline to 3 Months | We evaluated the serum alpha-fetoprotein levels at baseline and 3 months after the treatment initiation. | 3 months |
| Count of Participants With NS3/4A or NS5A Muttations Who Achieved SVR12 | We identified the NS3/4A or NS5A muttations by direct sequencing at baseline. Among participants who had mutations, we calcualted the rate of SVR12. | 3 months |
| Background |
| Ogawa E, Furusyo N, Yamashita N, Kawano A, Takahashi K, Dohmen K, Nakamuta M, Satoh T, Nomura H, Azuma K, Koyanagi T, Kotoh K, Shimoda S, Kajiwara E, Hayashi J; Kyushu University Liver Disease Study(KULDS) Group. Effectiveness and safety of daclatasvir plus asunaprevir for patients with hepatitis C virus genotype 1b aged 75 years and over with or without cirrhosis. Hepatol Res. 2017 Mar;47(3):E120-E131. doi: 10.1111/hepr.12738. Epub 2016 Jun 10. |
| 26095167 | Background | Ogawa E, Furusyo N, Kajiwara E, Nomura H, Kawano A, Takahashi K, Dohmen K, Satoh T, Azuma K, Nakamuta M, Koyanagi T, Kotoh K, Shimoda S, Hayashi J. Comparative effectiveness and safety study of triple therapy with simeprevir or telaprevir for non-cirrhotic patients with chronic hepatitis C virus genotype 1b infection. J Gastroenterol Hepatol. 2015 Dec;30(12):1759-67. doi: 10.1111/jgh.13016. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body mass index | Median | Inter-Quartile Range | kg/m^2 |
|
| Albumin | Median | Inter-Quartile Range | g/dL |
|
| Aspartate aminotransferase | Median | Inter-Quartile Range | U/L |
|
| Alanine aminotransferase | Median | Inter-Quartile Range | U/L |
|
| Gamma-glutamyl transpeptidase | Median | Inter-Quartile Range | U/L |
|
| alpha-fetoprotein | Median | Inter-Quartile Range | ng/mL |
|
| Cirrhosis | Count of Participants | Participants |
|
| HCV RNA level | Median | Inter-Quartile Range | logIU/mL |
|
| Treatment Naive | Count of Participants | Participants |
|
| HCV NS5A RAS | We identified the following as amino-acid resistance-associated substitutions (RAS) to non-structual 5A (NS5A) inhibitor by direct sequencing: NS5A gene amino acid positions 30, 31, and 93 for patients infected with HCV were examined at baseline. | Count of Participants | Participants |
|
|
| Primary | Change of eGFR Level (mL/Min/1.73m^2) From Baseline to 3 Months | We evaluated eGFR level at baseline and 3 months after the treatment initiation. | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | 3 months |
|
|
|
| Secondary | Sustained Virological Response-12 (SVR12) | SVR12 was defined as undetectable HCV RNA at week 12 after the end of treatment. | Three patients discontinued treatment due to adverse effects. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Change of Serum Alanine Aminotransferase (ALT) Level (U/L) From Baseline to 3 Months | We evaluated the serum ALT levels at baseline and 3 months after the treatment initiation. | Posted | Mean | Standard Deviation | U/L | 3 months |
|
|
|
| Secondary | Change of Serum Alpha-fetoprotein Level (ng/mL) From Baseline to 3 Months | We evaluated the serum alpha-fetoprotein levels at baseline and 3 months after the treatment initiation. | Posted | Mean | Standard Deviation | ng/mL | 3 months |
|
|
|
| Secondary | Count of Participants With NS3/4A or NS5A Muttations Who Achieved SVR12 | We identified the NS3/4A or NS5A muttations by direct sequencing at baseline. Among participants who had mutations, we calcualted the rate of SVR12. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 80 |
| 3 |
| 80 |
| 0 |
| 80 |
|
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |