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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Objective:
To coordinate active tracing of chronic hepatitis C patients lost to follow-up to inform them about there disease severity and treatment options.
Study design: This is a prospective cohort study, which will start as a pilot study in the Radboudumc Population: lost to follow-up chronic hepatitis C patients in the region Nijmegen. This so-called lost population consists of all patients, that in the past have been identified at the Radboudumc but who are currently lost to or have been withdrawn from follow-up. The time-span of interest will be 2000-2015. We estimate that this project will retrace 100 lost patients through this search.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lost to follow-up patients | This so-called lost population consists of all patients, that in the past have been diagnosed with hepatitis C at the Radboudumc but who are currently lost to or have been withdrawn from follow-up. The time-span of interest will be 2000-2015. |
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| Measure | Description | Time Frame |
|---|---|---|
| Liver Fibrosis Stage | Fibrosis stage according to elastography (liver stiffness in kPa) and/or liverbiopsy (staging according to Metavir). Stage F0/1 equals minimal fibrosis, stage F2 equals significant fibrosis and stage F3/F4 equals advanced fibrosis (including cirrhosis). For elastography, F0/1 is defined as liver stiffness <7.1 kPa, F2 as liver stiffness between 7.1 and 9.4 kPa and F3/F4 as liver stiffness >9.4 kPa. For liver biopsy, F0/1 is defined as the presence of no fibrosis or minimal fibrosis without the presence of septa, F2 as the presence of portal fibrosis with a few septa and F3/F4 as the presence of septal fibrosis or cirrhosis. The higher the fibrosis stage, the worse the outcome. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Reasons for Loss to Follow-up | through chart review or questioning screening event | Baseline |
| Genotype Distribution | Genotype distribution among RNA-positive patients |
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Inclusion Criteria:
Exclusion Criteria:
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lost to follow-up chronic hepatitis C patients in the region Nijmegen. This so-called lost population consists of all patients, that in the past have been diagnosed with hepatitis C at the Radboudumc but who are currently lost to or have been withdrawn from follow-up. The time-span of interest will be 2000-2015.
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| Name | Affiliation | Role |
|---|---|---|
| Joost Drenth, Md,PhD,Prof | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Nijmegen | Gelderland | 6500 HB | Netherlands |
Possibly individual data on primary and secondary outcomes can be requested from reserachers or shared via digital research environment
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After invitation, patients could not be enrolled (defined as the signing of informed consent) for multiple reasons. These reasons are described below.
After identification of lost to follow-up hepatitis C patients, patients who were alive and residing in the Netherlands were invited for re-evaluation at the outpatient clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Invited Lost to Follow-up Patients | Alive patients who were anti-HCV and/or HCV RNA positive in the period 2000-2015 who have not been treated and were residing in the Netherlands, were invited for re-evaluation at the outpatient clinic. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Re-evaluated Lost to Follow-up Patients | Invited lost to follow-up patients who were seen at the outpatient clinic. |
| 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 | Liver Fibrosis Stage | Fibrosis stage according to elastography (liver stiffness in kPa) and/or liverbiopsy (staging according to Metavir). Stage F0/1 equals minimal fibrosis, stage F2 equals significant fibrosis and stage F3/F4 equals advanced fibrosis (including cirrhosis). For elastography, F0/1 is defined as liver stiffness <7.1 kPa, F2 as liver stiffness between 7.1 and 9.4 kPa and F3/F4 as liver stiffness >9.4 kPa. For liver biopsy, F0/1 is defined as the presence of no fibrosis or minimal fibrosis without the presence of septa, F2 as the presence of portal fibrosis with a few septa and F3/F4 as the presence of septal fibrosis or cirrhosis. The higher the fibrosis stage, the worse the outcome. | Liver fibrosis was only assessed in patients who were HCV RNA-positive at baseline, i.e. in 5 out of a total of 10 re-evaluated patients. | Posted | Count of Participants | Participants | Baseline |
|
Full duration of treatment: 8 or 12 weeks.
Adverse events could only be reported in treated patients. Only 5 out of 10 re-evaluated patients were HCV RNA-positive and therefore only 5 had to be treated. Adverse events for these 5 patients are presented.
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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 | Treated Patients | RNA-positive patients who received treatment with interferon-free direct antiviral regimens. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. dr. J.P.H. Drenth | Radboudumc | 0031243613999 | joost.drenth@radboudumc.nl |
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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 | May 10, 2017 | Jan 3, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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blood serum samples will be saved in the biobank after participation
| Baseline |
| Fibrosis Progression | Fibrosis stage comparison in patients with a previously recorded fibrosis measurement, either with Fibroscan or liver biopsy. This previous measurement will be compared to the result of the Fibroscan performed during re-evaluation. | Baseline |
| Treatment Outcome | Sustained virological response in treated patients, defined as non-detectable HCV RNA at least 12 weeks after end of treatment | At least 12 weeks after end of treatment |
| Severe comorbidity/short life expectancy |
|
| Moved outside study region |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Country of birth | Count of Participants | Participants |
|
| HCV transmission route | Count of Participants | Participants |
|
| Years since last hospital contact | Median | Full Range | years |
|
| Treatment experienced | Defined as having any (previously) registered HCV treatment, e.g. (pegylated) interferon or direct acting antivirals, with or without ribavirin | Count of Participants | Participants |
|
| RNA-positive | Count of Participants | Participants |
|
LTFU patients who were still RNA-positive at the re-evaluation visit. |
|
|
| Secondary | Reasons for Loss to Follow-up | through chart review or questioning screening event | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Genotype Distribution | Genotype distribution among RNA-positive patients | HCV genotype was only determined in patients who were HCV RNA-positive at baseline, i.e. 5 out of a total of 10 re-evaluated patients. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Fibrosis Progression | Fibrosis stage comparison in patients with a previously recorded fibrosis measurement, either with Fibroscan or liver biopsy. This previous measurement will be compared to the result of the Fibroscan performed during re-evaluation. | Fibrosis progression could only be measured if patients had a previous fibrosis measurement, either by liver biopsy or liver stiffness measurement. This was the case in 3 out of 5 HCV RNA-positive patients, or 3 out of 10 re-evaluated patients. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Treatment Outcome | Sustained virological response in treated patients, defined as non-detectable HCV RNA at least 12 weeks after end of treatment | Posted | Count of Participants | Participants | At least 12 weeks after end of treatment |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
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| 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 |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Unknown |
|