Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2006-006529-25 | EudraCT Number |
Not provided
Not provided
Not provided
The study was terminated due to satisfaction of post-marketing commitments
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study P05063 is a 3-year long-term follow-up (LTFU) study in participants previously treated with boceprevir (BOC) or narlaprevir (NAR) in a Phase 1, 2, or 3 clinical study. Participants will be followed for up to 3.5 years after the end of their participation in the treatment protocol to document maintenance of the antiviral response (for sustained responders) and to characterize the long-term safety after use of this therapeutic regimen. LTFU procedures include collection of plasma samples for measuring Hepatitis C Virus ribonucleic acid (HCV-RNA) by polymerase chain reaction (PCR) and HCV sequence analysis. No drug therapy will be administered as part of this study.
In Part 1, participants who previously participated in one of nine boceprevir studies (P03523 [NCT00423670], P03659 [NCT00160251], P04487 [No NCT], P05101 [NCT00708500], P05216 [NCT00705432], P05411 [NCT00959699], P05514 [NCT00910624], P05685 [NCT00845065], and P06086 [NCT01023035]) were followed for response. In Part 2, participants who previously participated in one narlaprevir study (P05104 [NCT00797745]) were followed for response.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants from Boceprevir Studies | Other | Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study. |
|
| Participants from Narlaprevir Studies | Other | Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boceprevir | Biological | In previous treatment studies, boceprevir was administered as specified by the protocol. No treatment was administered on the current follow-up study (P05063, NCT00689390). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Relapse During the LTFU Among Sustained Responders From Previous Treatment Studies With Boceprevir or Narlaprevir (Durability of Virologic Response) | Durability of response was assessed by the number of participants who relapsed during the LTFU among those that had achieved sustained virologic response (SVR) by 24 weeks after treatment with boceprevir or narlaprevir in a previous Phase 1, 2, or 3 treatment study. In the current LTFU, participants were classified based on the last Hepatitis C Virus ribonucleic acid (HCV-RNA) result available at the time of the data cut-off date as follows: A participant was classified as a sustained virologic responder at a given time point if serum HCV-RNA was undetectable at that time point and there had not been a positive HCV-RNA since the participant was determined to have achieved SVR in the previous study. A participant was classified as a relapser if they were a sustained virologic responder in the previous treatment study and became serum HCV-RNA positive with no subsequent negative results during LTFU. | From End Of Treatment (EOT) date in the previous treatment study to the first date of a positive HCV RNA result for relapsers or the last contact date for non-relapsers in the LTFU (up to 3.5 years) |
| Kaplan-Meier Exposure-adjusted Relapse Rate | The distribution of time to relapse was summarized using Kaplan-Meier estimates for all participants who were sustained responders at 24 weeks post-treatment in the previous study. Exposure Adjusted Relapse Rate = 1000 × (number of relapses) / (Total exposure time in years). Total exposure time in years = [(total number of days from last day of treatment to the last follow-up day for all subjects who did not relapse) + (total number of days from last day of treatment to the day of relapse for those who relapsed)] / 365.25 days [for 1 year]. | From EOT date in the previous treatment study to the first date of a positive HCV RNA result for relapsers or the last contact date for non-relapsers in the LTFU (up to 3.5 years) |
| Number of Participants With HCV Treatment-Emergent Resistance Associated Variants (TE-RAVs) of NS3/4A Protease Loci | Plasma samples of all participants receiving at least one dose of study medication in a previous treatment protocol were evaluated by population sequencing and analyzed to detect amino acid variants in the NS3/4A protease known to be associated with reduced susceptibility to boceprevir and narlaprevir. RAVs in the NS3/4A protease gene were evaluated at 12 loci (V36, Q41, F43, T54, V55, V107, R155, A156, V158, D168, I/V170 and M175) on the basis of in vitro studies. A TE-RAV was defined as a RAV not present at baseline and that had not returned to wild type (WT) while the participant was still on treatment. The number of participants with TE-RAVS detected at the EOT in the previous treatment study are reported below, followed by those participants with TE-RAVS that returned to WT during the LTFU (among those with detected TE-RAVS). |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25446895 | Background | Howe AY, Long J, Nickle D, Barnard R, Thompson S, Howe J, Alves K, Wahl J. Long-term follow-up of patients receiving boceprevir for treatment of chronic hepatitis C. Antiviral Res. 2015 Jan;113:71-8. doi: 10.1016/j.antiviral.2014.10.010. Epub 2014 Oct 24. | |
| 27219495 | Derived | Barnard R, Chopra A, James I, Blinco J, Watson MW, Jabara CB, Hazuda D, Lemon SM, Mallal S, Gaudieri S. Primer ID ultra-deep sequencing reveals dynamics of drug resistance-associated variants in breakthrough hepatitis C viruses: relevance to treatment outcome and resistance screening. Antivir Ther. 2016;21(7):567-577. doi: 10.3851/IMP3056. Epub 2016 May 24. |
Not provided
| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
Not provided
Not provided
Not provided
1954 participants enrolled in this long-term follow-up (LTFU) study, with 1907 participants from 9 boceprevir studies and 47 participants from 1 narlaprevir study.
Participants were recruited from 9 boceprevir studies (P03523 [NCT00423670], P03659 [NCT00160251], P04487 [No NCT], P05101 [NCT00708500], P05216 [NCT00705432], P05411 [NCT00959699], P05514 [NCT00910624], P05685 [NCT00845065], and P06086 [NCT01023035]) and 1 narlaprevir study (P05104 [NCT00797745]).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Participants From Boceprevir Studies | Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Narlaprevir | Biological | In previous treatment studies, narlaprevir was administered as specified by the protocol. No treatment was administered on the current follow-up study (P05063, NCT00689390). |
|
|
| Peginterferon alfa-2b | Biological | In previous treatment studies, peginterferon alfa-2b was administered as specified by the protocol. No treatment was administered on the current follow-up study (P05063, NCT00689390). |
|
|
| Ribavirin | Drug | In previous treatment studies, ribavirin was administered as specified by the protocol. No treatment was administered on the current follow-up study (P05063, NCT00689390). |
|
|
| Blood/Plasma Collection | Other | Blood samples were collected at all visits during the LTFU for blood chemistry and hematology. Plasma samples were collected at all visits as appropriate from participants who were sustained responders at the end of FU in the previous treatment protocol for HCV-RNA PCR and HCV sequence analysis. |
|
| From EOT in the previous treatment study to the last available date in the LTFU (up to 3.5 years) |
| Number of Participants With Serious Adverse Events (SAEs) Reported During the LTFU | Long-term safety was assessed based on the SAEs reported during the LTFU period. An SAE was any adverse drug or biologic or device experience occurring at any dose that resulted in any of the following outcomes: death, life-threatening AE, persistent or significant disability/incapacity, required in-patient hospitalization or prolongs hospitalization, congenital anomaly or birth defect. Important medical events that did not result in any of these outcomes could still be considered SAEs if they jeopardized the participant and/or required medical/surgical intervention, based on appropriate medical judgment. Grade 4 laboratory abnormalities and out of normal range liver function tests that were not accompanied by clinical manifestations were NOT considered SAEs. | From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years) |
| Number of Participants That Discontinued the LTFU Due to SAEs | An SAE was any adverse drug or biologic or device experience occurring at any dose that resulted in any of the following outcomes: death, life-threatening AE, persistent or significant disability/incapacity, required in-patient hospitalization or prolongs hospitalization, congenital anomaly or birth defect. Important medical events that did not result in any of these outcomes could still be considered SAEs if they jeopardized the participant and/or required medical/surgical intervention, based on appropriate medical judgment. Grade 4 laboratory abnormalities and out of normal range liver function tests that were not accompanied by clinical manifestations were NOT considered SAEs. | From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years) |
| FG001 | Participants From Narlaprevir Studies | Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All Enrolled Participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Participants From Boceprevir Studies | Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study. |
| BG001 | Participants From Narlaprevir Studies | Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| 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 | Number of Participants With Relapse During the LTFU Among Sustained Responders From Previous Treatment Studies With Boceprevir or Narlaprevir (Durability of Virologic Response) | Durability of response was assessed by the number of participants who relapsed during the LTFU among those that had achieved sustained virologic response (SVR) by 24 weeks after treatment with boceprevir or narlaprevir in a previous Phase 1, 2, or 3 treatment study. In the current LTFU, participants were classified based on the last Hepatitis C Virus ribonucleic acid (HCV-RNA) result available at the time of the data cut-off date as follows: A participant was classified as a sustained virologic responder at a given time point if serum HCV-RNA was undetectable at that time point and there had not been a positive HCV-RNA since the participant was determined to have achieved SVR in the previous study. A participant was classified as a relapser if they were a sustained virologic responder in the previous treatment study and became serum HCV-RNA positive with no subsequent negative results during LTFU. | All participants who were sustained responders at 24 weeks post-treatment in the previous study and who had available data were included in the analysis. | Posted | Number | participants | From End Of Treatment (EOT) date in the previous treatment study to the first date of a positive HCV RNA result for relapsers or the last contact date for non-relapsers in the LTFU (up to 3.5 years) |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Kaplan-Meier Exposure-adjusted Relapse Rate | The distribution of time to relapse was summarized using Kaplan-Meier estimates for all participants who were sustained responders at 24 weeks post-treatment in the previous study. Exposure Adjusted Relapse Rate = 1000 × (number of relapses) / (Total exposure time in years). Total exposure time in years = [(total number of days from last day of treatment to the last follow-up day for all subjects who did not relapse) + (total number of days from last day of treatment to the day of relapse for those who relapsed)] / 365.25 days [for 1 year]. | All participants who were sustained responders at 24 weeks post-treatment in the previous study and who had available data were included in the analysis. | Posted | Number | relapses per 1,000 person-years | From EOT date in the previous treatment study to the first date of a positive HCV RNA result for relapsers or the last contact date for non-relapsers in the LTFU (up to 3.5 years) |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With HCV Treatment-Emergent Resistance Associated Variants (TE-RAVs) of NS3/4A Protease Loci | Plasma samples of all participants receiving at least one dose of study medication in a previous treatment protocol were evaluated by population sequencing and analyzed to detect amino acid variants in the NS3/4A protease known to be associated with reduced susceptibility to boceprevir and narlaprevir. RAVs in the NS3/4A protease gene were evaluated at 12 loci (V36, Q41, F43, T54, V55, V107, R155, A156, V158, D168, I/V170 and M175) on the basis of in vitro studies. A TE-RAV was defined as a RAV not present at baseline and that had not returned to wild type (WT) while the participant was still on treatment. The number of participants with TE-RAVS detected at the EOT in the previous treatment study are reported below, followed by those participants with TE-RAVS that returned to WT during the LTFU (among those with detected TE-RAVS). | All participants with TE-RAVs who received at least one dose of study medication in a previous Phase 1, 2, or 3 boceprevir or narlaprevir clinical study. Participants could have had more than one TE-RAV. All TE-RAVs were observed in participants in the boceprevir studies (i.e. none of the participants in the narlaprevir study had a TE-RAV). | Posted | Number | participants | From EOT in the previous treatment study to the last available date in the LTFU (up to 3.5 years) |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Serious Adverse Events (SAEs) Reported During the LTFU | Long-term safety was assessed based on the SAEs reported during the LTFU period. An SAE was any adverse drug or biologic or device experience occurring at any dose that resulted in any of the following outcomes: death, life-threatening AE, persistent or significant disability/incapacity, required in-patient hospitalization or prolongs hospitalization, congenital anomaly or birth defect. Important medical events that did not result in any of these outcomes could still be considered SAEs if they jeopardized the participant and/or required medical/surgical intervention, based on appropriate medical judgment. Grade 4 laboratory abnormalities and out of normal range liver function tests that were not accompanied by clinical manifestations were NOT considered SAEs. | All enrolled participants were included in safety analyses. | Posted | Number | participants | From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years) |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants That Discontinued the LTFU Due to SAEs | An SAE was any adverse drug or biologic or device experience occurring at any dose that resulted in any of the following outcomes: death, life-threatening AE, persistent or significant disability/incapacity, required in-patient hospitalization or prolongs hospitalization, congenital anomaly or birth defect. Important medical events that did not result in any of these outcomes could still be considered SAEs if they jeopardized the participant and/or required medical/surgical intervention, based on appropriate medical judgment. Grade 4 laboratory abnormalities and out of normal range liver function tests that were not accompanied by clinical manifestations were NOT considered SAEs. | All enrolled participants were included in safety analyses. | Posted | Number | participants | From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years) |
|
From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years)
As specified in the protocol, only serious adverse events (SAEs) were collected. Other Adverse Events were not monitored and not collected, thus no participants were at risk for these events. All enrolled participants were included in safety analyses.
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 | Participants From Boceprevir Studies | Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study. | 136 | 1,907 | 0 | 0 | ||
| EG001 | Participants From Narlaprevir Studies | Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study. | 2 | 47 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| CARDIOPULMONARY FAILURE | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| CORONARY ARTERY STENOSIS | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| ENDOCARDIAL FIBROELASTOSIS | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
| |
| HUNTINGTON'S DISEASE | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
| |
| GOITRE | Endocrine disorders | MedDRA 17.1 | Systematic Assessment |
| |
| CORNEAL OEDEMA | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| ANAL FISTULA | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| ANAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| COLITIS ISCHAEMIC | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| DIVERTICULAR PERFORATION | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| GASTRIC ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| HERNIAL EVENTRATION | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| LARGE INTESTINE POLYP | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| MELAENA | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| OESOPHAGEAL VARICES HAEMORRHAGE | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| PALATAL DISORDER | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| VARICES OESOPHAGEAL | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| MULTI-ORGAN FAILURE | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| HEPATIC CIRRHOSIS | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| ACUTE HEPATITIS B | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| APPENDICITIS PERFORATED | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| HEPATITIS C | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| HERPES SIMPLEX PNEUMONIA | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| RETINITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| ALCOHOL POISONING | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| FIBULA FRACTURE | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| FOOT FRACTURE | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| HAND FRACTURE | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| INJURY | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| LACERATION | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| SCAPULA FRACTURE | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| STAB WOUND | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| TIBIA FRACTURE | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| TOXICITY TO VARIOUS AGENTS | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| WOUND COMPLICATION | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| DIABETIC COMPLICATION | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| DIABETIC KETOACIDOSIS | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| MALNUTRITION | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| METABOLIC ACIDOSIS | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| CERVICAL SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| LUMBAR SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| RHABDOMYOLYSIS | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| ADENOMA BENIGN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| ANAL CANCER STAGE 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| BLADDER CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| BRAIN NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| BRONCHIOLOALVEOLAR CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| DIFFUSE LARGE B-CELL LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| HEPATIC CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| HEPATOCELLULAR CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| INVASIVE DUCTAL BREAST CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| LUNG ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| LUNG ADENOCARCINOMA STAGE IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| METASTASES TO LIVER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| PANCREATIC CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| RECTAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| RENAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| SALIVARY GLAND CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| SKIN CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF HEAD AND NECK | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| THYROID CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| ARACHNOID CYST | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| TENSION HEADACHE | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| TREMOR | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| COMPLETED SUICIDE | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| CALCULUS URETERIC | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| UTEROVAGINAL PROLAPSE | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
| |
| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| PULMONARY FIBROSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| CORONARY ARTERY BYPASS | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
| |
| FINGER AMPUTATION | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
| |
| HIP ARTHROPLASTY | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
| |
| KNEE ARTHROPLASTY | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
| |
| LIVER TRANSPLANT | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
| |
| SHOULDER ARTHROPLASTY | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
| |
| SURGERY | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
| |
| VALVULOPLASTY CARDIAC | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
| |
| AORTIC ANEURYSM | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| PERIPHERAL ARTERY THROMBOSIS | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
Not provided
Principal Investigator (PI) agrees to provide to the sponsor 30 days prior to submission for publication or presentation, review results communications. Sponsor shall have editorial rights with respect to results communications and the right to review and comment on the data analysis and presentation with regard to proprietary information, the accuracy of the information contained in the publication, and to ensure that the presentation is fairly balanced and in compliance with FDA regulations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| 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 |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C512204 | N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide |
| C552043 | narlaprevir |
| C417083 | peginterferon alfa-2b |
| D012254 | Ribavirin |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| ≥65 years |
|
| Male |
|
| OG002 | Previous SVR on PR Only | Participants who previously received PR only in boceprevir or narlaprevir treatment studies and achieved SVR. No treatment was administered in the current follow-up study |
|
|
| OG001 | Participants From Narlaprevir Studies With TE-RAVs | Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study. |
|
|
Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study. |
|
|
|
|