Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
Not provided
Not provided
Not provided
Open-label experimental trial of 12 weeks of Viekira Pak treatment ± ribavirin or Mavyret for adults with chronic kidney disease and hepatitis C.
The objective of this study is to evaluate the effect of paritaprevir/ritonavir, ombitasvir, dasabuvir (referred to as Viekira Pak) ± ribavirin or Glecaprevir / Pibrentasvir (referred to as Mavyret) for adults with advanced CKD with an estimated glomerular filtration rate (eGFR) less than 45ml/min that are infected with hepatitis C virus (HCV) genotype 1 and to determine the effect of treatment on traditional and novel markers of kidney function and cardiovascular disease risk in patients with advanced CKD. During the course of this prospective, single arm treatment trial, we will measure currently accepted markers of kidney function and novel biomarkers of CKD progression to determine if they improve with eradication of HCV.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viekira Pak ± ribavirin or Mavyret | Experimental | 12 week therapy with Viekira Pak ± ribavirin 8 or 12 week therapy with Mavyret |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viekira Pak ± ribavirin | Drug | 12 weeks treatment with AbbVie Viekira Pak ± ribavirin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Change in Urine Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment | Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below. | 52 Weeks |
| Average Change in Urine Interleukin (IL)-6 From Baseline to Post-treatment | Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below. | 52 weeks |
| Average Change in Plasma Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment | Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below. | 52 weeks |
| Average Change in Plasma Interferon Gamma-induced Protein 10 (IP-10) From Baseline to Post-treatment | Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Suffered Adverse Events Related to Study Drug (Safety and Tolerability) | Safety and tolerability of Viekira Pak treatment in CKD patients will be assessed by number of patients who suffered adverse events (serious or otherwise) deemed to be related to study drug. | 12 weeks |
| Number of Patients Who Had Sustained Virologic Response at 12-weeks (SVR12) Post-treatment (Efficacy of Treatment) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Raymond T Chung, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
Results data will be shared with the study sponsor and publication of data is anticipated.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Viekira Pak ± Ribavirin or Mavyret | 12 week therapy with Viekira Pak ± ribavirin (2 patients) 8 or 12 week therapy with Mavyret (8 patients) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Two patients received AbbVie Viekira Pak ± ribavirin, and eight patients received Abbvie Mavyret (glecaprevir/pibrentasvir).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Viekira Pak ± Ribavirin or Mavyret | 12 week therapy with Viekira Pak ± ribavirin (2 patients) 8 or 12 week therapy with Mavyret (8 patients) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Average Change in Urine Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment | Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below. | 2 patients did not have urine TNF-alpha tested at these timepoints. | Posted | Mean | Standard Deviation | ng/g | 52 Weeks |
|
Each patient was followed for one year after initiation of treatment.
Adverse events data collection was done at each study visit.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Viekira Pak ± Ribavirin or Mavyret | 12 week therapy with Viekira Pak ± ribavirin (2 patients) 8 or 12 week therapy with Mavyret (8 patients |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | Non-systematic Assessment | Occurred 30 weeks post-treatment, was deemed not related to study drug. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| muscle pain in leg | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Reported at week 12 visit, deemed not related to study drug. |
Our study has several limitations. Our pilot trial was limited by the small number of patients enrolled. Additionally, two subjects were lost to follow-up, decreasing the power of our analysis comparing pre- and post-treatment kidney function and biomarkers. Thus, the analysis presented is descriptive in nature. The analysis is limited by the absence of a control group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Raymond Chung | Massachusetts General Hospital | 617-726-5925 | Chung.Raymond@mgh.harvard.edu |
Not provided
| 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 25, 2019 | Sep 8, 2021 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000654128 | glecaprevir and pibrentasvir |
Not provided
Not provided
Not provided
This a single-arm study. Initially, Viekira Pak was available through Abbvie. However, once Mavyret became available, it supplanted Viekira Pak as the study medication.
Not provided
Not provided
Not provided
Not provided
| Mavyret | Drug | 8 or 12 weeks treatment with AbbVie Mavyret |
|
| 52 Weeks 52 Weeks 52 weeks |
| Average Change in Plasma Interferon (IFN)-Gamma From Baseline to Post-treatment | Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below. | 52 weeks |
| Average Change in Plasma Interleukin (IL)-6 From Baseline to Post-treatment | Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below. | 52 weeks |
Efficacy will be determined by negative HCV RNA viral load measured during the 12 week treatment period as well as 12 weeks after the last dose. |
| 24 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Hepatitis C genotype | Count of Participants | Participants |
|
| Baseline estimated glomerular filtration rate (eGFR) | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Average Change in Urine Interleukin (IL)-6 From Baseline to Post-treatment | Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below. | 2 patients did not have urine IL-6 tested at these timepoints. | Posted | Mean | Standard Deviation | ng/g | 52 weeks |
|
|
|
| Primary | Average Change in Plasma Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment | Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below. | 2 patients did not have plasma TNF-alpha tested at these timepoints. | Posted | Mean | Standard Deviation | pg/mL | 52 weeks |
|
|
|
| Primary | Average Change in Plasma Interferon Gamma-induced Protein 10 (IP-10) From Baseline to Post-treatment | Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below. | 2 patients did not have plasma IP-10 tested at these timepoints. | Posted | Mean | Standard Deviation | pg/mL | 52 Weeks 52 Weeks 52 weeks |
|
|
|
| Primary | Average Change in Plasma Interferon (IFN)-Gamma From Baseline to Post-treatment | Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below. | 2 patients did not have plasma IFN-gamma tested at these timepoints. | Posted | Mean | Standard Deviation | pg/mL | 52 weeks |
|
|
|
| Primary | Average Change in Plasma Interleukin (IL)-6 From Baseline to Post-treatment | Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below. | 2 patients did not have plasma IL-6 tested at these timepoints. | Posted | Mean | Standard Deviation | pg/mL | 52 weeks |
|
|
|
| Secondary | Number of Patients Who Suffered Adverse Events Related to Study Drug (Safety and Tolerability) | Safety and tolerability of Viekira Pak treatment in CKD patients will be assessed by number of patients who suffered adverse events (serious or otherwise) deemed to be related to study drug. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Number of Patients Who Had Sustained Virologic Response at 12-weeks (SVR12) Post-treatment (Efficacy of Treatment) | Efficacy will be determined by negative HCV RNA viral load measured during the 12 week treatment period as well as 12 weeks after the last dose. | 2 patients did not have hepatitis C checked after 12-weeks post-treatment; thus, we cannot definitively determine that they achieved SVR12. | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| 0 |
| 10 |
| 5 |
| 10 |
| 8 |
| 10 |
|
| Seizure | Nervous system disorders | Non-systematic Assessment | Occurred 19 weeks post-treatment, was deemed not related to study drug. |
|
| Fall / loss of consciousness | Nervous system disorders | Non-systematic Assessment | Occurred 22 weeks post-treatment, was deemed not related to study drug. |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment | Occurred 29 weeks post-treatment, was deemed not related to study drug. |
|
| Cryoglobulinemic glomerulonephritis | Renal and urinary disorders | Non-systematic Assessment | Occurred week 2 of treatment, was deemed not related to study drug. |
|
| Heart block | Cardiac disorders | Non-systematic Assessment | Occurred week 5 of treatment, deemed possibly related to study drug (digoxin interaction with Mavyret). |
|
| Hypertensive emergency | Cardiac disorders | Non-systematic Assessment | Occurred 39 weeks post-treatment, was deemed not related to study drug. |
|
|
| anemia | Blood and lymphatic system disorders | Non-systematic Assessment | Observed at week 12 visit, deemed not related to study drug. |
|
| fatigue | Nervous system disorders | Non-systematic Assessment | For one patient, reported at week 8 visit, deemed possibly related to study drug. For another, reported at week 4 visit, deemed possibly related to study drug. For another, reported at week 2 visit, deemed possibly related to study drug. |
|
| cryoglobulinemia | Blood and lymphatic system disorders | Non-systematic Assessment | Observed at week 1 visit, deemed not related to study drug. |
|
| slow ventricular response | Cardiac disorders | Non-systematic Assessment | Observed at week 8 visit and 12-weeks post treatment, deemed not related to study drug. |
|
| high potassium | Renal and urinary disorders | Non-systematic Assessment | Observed at week 1 of treatment, deemed not related to study drug. |
|
Not provided
Not provided
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |