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| ID | Type | Description | Link |
|---|---|---|---|
| TMC435HPC3002 | Other Identifier | Janssen R&D Ireland | |
| 2010-019843-20 | EudraCT Number |
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The purpose of this study is to investigate durability of SVR in chronic HCV patients who achieved SVR in the previous study with TMC435-containing regimen and time for resistance associated mutations to return to baseline in chronic HCV patients who did not achieve SVR in the previous study with TMC435-containing regimen.
This is a 3-year follow-up study in patients who completed the last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study in which they received TMC435, in combination with pegylated interferon and ribavirin, for the treatment of hepatitis C infection. The entire study duration for each patients will be approximately 36 months. The medical follow-up of the patients will be performed according to the local standard of care. This study will evaluate the levels of hepatitis C virus in the blood circulation, as well as safety and alpha-fetoprotein testing and the change in sequence of HCV NS3/4A region over time in patients with confirmed detectable HCV RNA at last post-therapy follow-up visit of the previous TMC435 study. In this study the development of liver disease progression will also be assessed. No medication will be administered in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: TMC 435 - Patients With SVR at LPVPS | Other | Patients with sustained virologic response (SVR) who completed last post-therapy follow-up visit of the previous study (LPVPS) [Phase IIb or Phase III] in which they received a TMC435-containing regimen for the treatment of HCV infection. |
|
| Group 2: TMC 435 - Patients With No SVR at LPVPS | Other | Patients with no sustained virologic response (SVR) who completed last post-therapy follow-up visit of the previous study (LPVPS) [Phase IIb or Phase III] in which they received a TMC435-containing regimen for the treatment of HCV infection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No treatment | Drug | No treatment was given to patients during this study as this is a follow-up study of previous Phase IIb or Phase III in which they received a TMC435-containing regimen. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Maintaining SVR at the Last Available Visit | The SVR rate is the proportion (%) of participants with HCV RNA less than (<) 25 International Units/milliliter (IU/mL). | Last Available Visit (Month 36 for subjects completing the study) |
| Overall Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA at the Last Visit of the Previous Study | Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study. | Baseline and Month 36 |
| Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (With Q80K at Baseline) at the Last Visit of the Previous Study | Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study. | Baseline and Month 36 |
| Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (Without Q80K at Baseline) at the Last Visit of the Previous Study | Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Late Viral Relapse | Relapse at any time after the LPVPS until the last individual visit of this study. All participants maintained SVR until the last available visit. No late viral relapse was therefore observed. | End of study (at month 36) |
| Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen R&D Ireland Clinical Trial | Janssen R&D Ireland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bakersfield | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29378602 | Derived | Zoulim F, Moreno C, Lee SS, Buggisch P, Horban A, Lawitz E, Corbett C, Lenz O, Fevery B, Verbinnen T, Shukla U, Jessner W. A 3-year follow-up study after treatment with simeprevir in combination with pegylated interferon-alpha and ribavirin for chronic hepatitis C virus infection. Virol J. 2018 Jan 30;15(1):26. doi: 10.1186/s12985-018-0936-4. |
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In total 250 participants were screened and among those 249 were enrolled into the study (200 participants with SVR and 49 participants with no SVR).
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| ID | Title | Description |
|---|---|---|
| FG000 | SVR at Last Post-Therapy Follow-up Visit of Previous Study | Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study. |
| FG001 | No SVR at Last Post-Therapy Follow-up Visit of Previous Study |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline and Month 36 |
| End of study (at month 36) |
| La Jolla |
| California |
| United States |
| Los Angeles | California | United States |
| Jacksonville | Florida | United States |
| Orlando | Florida | United States |
| Chicago | Illinois | United States |
| New Orleans | Louisiana | United States |
| Saint Paul | Minnesota | United States |
| Tupelo | Mississippi | United States |
| Chapel Hill | North Carolina | United States |
| Cincinnati | Ohio | United States |
| San Antonio | Texas | United States |
| Antwerp | Belgium |
| Bruges | Belgium |
| Brussels | Belgium |
| Ghent | Belgium |
| Leuven | Belgium |
| Calgary | Alberta | Canada |
| Ottawa | Ontario | Canada |
| Toronto | Ontario | Canada |
| Montreal | Quebec | Canada |
| Montreal | Canada |
| Créteil | France |
| Grenoble | France |
| Lyon | France |
| Nice | France |
| Paris | France |
| Vandœuvre-lès-Nancy | France |
| Berlin | Germany |
| Cologne | Germany |
| Düsseldorf | Germany |
| Frankfurt A. M. | Germany |
| Freiburg im Breisgau | Germany |
| Hamburg | Germany |
| Hanover | Germany |
| Kiel | Germany |
| Würzburg | Germany |
| Bialystok | Poland |
| Bydgoszcz | Poland |
| Czeladź | Poland |
| Mysłowice | Poland |
| Warsaw | Poland |
| Moscow | Russia |
| Nizhny Novgorod | Russia |
| Saint Petersburg | Russia |
| Samara | Russia |
| Smolensk | Russia |
| Stavropol | Russia |
Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SVR at Last Post-Therapy Follow-up Visit of Previous Study | Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study. |
| BG001 | No SVR at Last Post-Therapy Follow-up Visit of Previous Study | Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Percentage of Participants Maintaining SVR at the Last Available Visit | The SVR rate is the proportion (%) of participants with HCV RNA less than (<) 25 International Units/milliliter (IU/mL). | All participants with SVR at LPVPS were included in the population analysis set. | Posted | Number | 95% Confidence Interval | Percentage of participants | Last Available Visit (Month 36 for subjects completing the study) |
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| Primary | Overall Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA at the Last Visit of the Previous Study | Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study. | "N" signifies number of participants with no SVR at LPVPS and with available sequence data. "n" defines the number of participants analyzed at specified time point. | Posted | Number | Percentage of participants | Baseline and Month 36 |
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| Secondary | Percentage of Participants With Late Viral Relapse | Relapse at any time after the LPVPS until the last individual visit of this study. All participants maintained SVR until the last available visit. No late viral relapse was therefore observed. | Late viral relapse was evaluated in all enrolled participants with SVR at LPVPS. | Posted | Number | percentage of participants | End of study (at month 36) |
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| Secondary | Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability | Posted | Number | Participants | End of study (at month 36) |
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| Primary | Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (With Q80K at Baseline) at the Last Visit of the Previous Study | Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study. | "N" signifies number of particpants with no SVR at LPVPS and with available sequence data. "n" defines the number of participants analyzed at specified time point. | Posted | Number | Percentage of participants | Baseline and Month 36 |
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| Primary | Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (Without Q80K at Baseline) at the Last Visit of the Previous Study | Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study. | "N" signifies number of particpants with no SVR at LPVPS and with available sequence data. "n" defines the number of participants analyzed at specified time point. | Posted | Number | Percentage of participnats | Baseline and Month 36 |
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End of study (36 Months)
Only Adverse Events associated with a study procedure or the use of any J&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.
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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 | SVR at Last Post-Therapy Follow-up Visit of Previous Study | Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study. | 10 | 200 | 4 | 200 | ||
| EG001 | No SVR at Last Post-Therapy Follow-up Visit of Previous Study | Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study. | 0 | 49 | 1 | 49 | ||
| EG002 | Total | All Enrolled Subjects | 10 | 249 | 5 | 249 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
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| Gastrointestinal tract adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
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| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
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| Varices oesophageal | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
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| Biliary colic | Hepatobiliary disorders | MedDRA Version 14.1 | Non-systematic Assessment |
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| Cholangitis | Hepatobiliary disorders | MedDRA Version 14.1 | Non-systematic Assessment |
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| Hydrocholecystis | Hepatobiliary disorders | MedDRA Version 14.1 | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA Version 14.1 | Non-systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bile duct stone | Hepatobiliary disorders | MedDRA Version 14.1 | Non-systematic Assessment |
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| Cholecystitis chronic | Hepatobiliary disorders | MedDRA Version 14.1 | Non-systematic Assessment |
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| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
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| Alpha 1 foetoprotein increased | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
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| Dysarthria | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
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| Hemiparesis | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
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A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Responsible Scientist | Janssen Research & Development, LLC | ClinicalTrialDisclosure@its.jnj.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D004066 | Digestive System Diseases |
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| Male |
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