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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004695-11 | EudraCT Number |
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The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Peginterferon Lambda-1a + RBV + TVR | Experimental |
| |
| Part B (Arm 1): Peginterferon Lambda-1a + RBV + TVR | Experimental |
| |
| Part B (Arm 2): Peginterferon Lambda-2a + RBV + TVR | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon Lambda-1a | Biological | Syringes, subcutaneous (SC), 180μg, Once weekly, 24 or 48 weeks depending on response |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A | eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL). | Assessed at Week 4 and Week 12, week 12 reported |
| Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B | SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL). | Follow-up Week 12 |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal product. An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or caused prolongation of existing hospitalization. | Day 1 of treatment up to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A | SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ =25 IU/mL; limit of detection ~ 10 IU/mL). | Follow-up Week 12 |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Gastroenterology Associates, P.C. | Birmingham | Alabama | 35209 | United States | ||
| The Kirklin Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23743475 | Derived | Heim MH. 25 years of interferon-based treatment of chronic hepatitis C: an epoch coming to an end. Nat Rev Immunol. 2013 Jul;13(7):535-42. doi: 10.1038/nri3463. Epub 2013 Jun 7. |
| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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Out of 881 participants who were enrolled, 648 were randomized and only 644 were treated. 27 participants were treated in Part A and 617 participants were treated in Part B of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Participants with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
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| Peginterferon Alfa-2a | Biological | Syringes, SC, 180μg, Once weekly, 24 or 48 weeks depending on response |
|
|
| Ribavirin | Drug | Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 24 or 48 weeks depending on response |
|
| Telaprevir | Drug | Tablets, Oral, 750 mg, three times a day, 12 weeks only |
|
|
| Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A | SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection ~ 10 IU/mL). The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants. | Follow up week 24 |
| Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B | SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL). | Follow-up Week 12 |
| Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B | Cytopenic abnormalities included anemia defined as hemoglobin <10 grams/decilitre; neutropenia defined as Absolute neutrophil count (ANC) <750 cubic millimetre (mm^3); thrombocytopenia defined as platelets <50,000 mm^3. | After Day 1 of treatment up to Week 48 |
| Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B | eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL). | Week 4 and Week 12 |
| Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B | Flu-like symptoms included pyrexia, chills, and pain. Musculoskeletal symptoms included arthralgia, myalgia, and back pain. | After Day 1 of treatment up to Week 48 |
| Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B | SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection ~ 10 IU/mL). | Follow-up Week 24 |
| Percentage of Participants With Rash | All skin reactions involving rash or rash-like events that occurred on treatment were reported. | After Day 1 of treatment up to Week 48 |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| The University Of Alabama Of Birmingham | Birmingham | Alabama | 35294 | United States |
| Anaheim Clinical Trials Llc | Anaheim | California | 92801 | United States |
| Sc Clinical Research, Inc. | Garden Grove | California | 92844 | United States |
| Va Long Beach Healthcare System | Long Beach | California | 90822 | United States |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Va Greater Los Angeles Healthcare System | Los Angeles | California | 90073 | United States |
| University Of California, San Francisco/Sf General Hospital | San Francisco | California | 94110 | United States |
| South Bay Ge Medical Group | Torrance | California | 90505 | United States |
| Orlando Va Medical Center | Orlando | Florida | 32803 | United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| Infectious Disease Research Institute, Inc. | Tampa | Florida | 33614 | United States |
| Gastrointestinal Specialists Of Georgia Pc | Marietta | Georgia | 30060 | United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| Saint Luke'S Transplant Specialists | Kansas City | Missouri | 64111 | United States |
| Saint Louis University | St Louis | Missouri | 63104 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28204 | United States |
| Options Health Research, Llc | Tulsa | Oklahoma | 74104 | United States |
| Healthcare Research Consultants | Tulsa | Oklahoma | 74135 | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| Texas Clinical Research Institute | Arlington | Texas | 76012 | United States |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Clinical Research Centers Of America | Murray | Utah | 84123 | United States |
| Metropolitan Research | Annandale | Virginia | 22003 | United States |
| Bon Secours St. Mary'S Hospital Of Richmond, Inc. | Newport News | Virginia | 23602 | United States |
| Digestive And Liver Disease Specialists | Norfolk | Virginia | 23502 | United States |
| Local Institution | Graz | 8036 | Austria |
| Local Institution | Linz | 4010 | Austria |
| Local Institution | Brussels | 1200 | Belgium |
| Local Institution | Edegem | 2650 | Belgium |
| Local Institution | Leuven | 3000 | Belgium |
| Local Institution | Liège | 4000 | Belgium |
| Local Institution | Salvador | Estado de Bahia | 40110-160 | Brazil |
| Local Institution | Salvador | Estado de Bahia | 40110 | Brazil |
| Local Institution | Curitiba | Paraná | 80240-280 | Brazil |
| Local Institution | Curitiba | Paraná | 80240 | Brazil |
| Local Institution | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Local Institution | Porto Alegre | Rio Grande do Sul | 90035 | Brazil |
| Local Institution | Botucatu | São Paulo | 18618-000 | Brazil |
| Local Institution | Botucatu | São Paulo | 18618 | Brazil |
| Local Institution | Rio de Janeiro | 21040-000 | Brazil |
| Local Institution | Rio de Janeiro | 21040 | Brazil |
| Local Institution | São Paulo | 04035-970 | Brazil |
| Local Institution | São Paulo | 04035 | Brazil |
| University Of Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
| Liver And Intestinal Research Centre (Lair) | Vancouver | British Columbia | V5Z 1H2 | Canada |
| Gastrointestinal Research Institute (G.I.R.I.) | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Percuro Clinical Research Ltd | Victoria | British Columbia | V8V 3P9 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2N2 | Canada |
| Hopital Maisonneuve-Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| Local Institution | Hradec Králové | 500 05 | Czechia |
| Local Institution | Prague | 120 00 | Czechia |
| Local Institution | Prague | 140 21 | Czechia |
| Local Institution | Orléans | 45067 | France |
| Local Institution | Poitiers | 86021 | France |
| Local Institution | Rennes | 35033 | France |
| Local Institution | Rouen | 76031 | France |
| Local Institution | Toulouse | 31059 | France |
| Local Institution | Villejuif | 94804 | France |
| Local Institution | Berlin | 10969 | Germany |
| Local Institution | Essen | 45122 | Germany |
| Local Institution | Frankfurt | 60590 | Germany |
| Local Institution | Hamburg | 20246 | Germany |
| Local Institution | Hanover | 30625 | Germany |
| Local Institution | Münster | 48149 | Germany |
| Local Institution | Ulm | 89081 | Germany |
| Local Institution | Haifa | 31096 | Israel |
| Local Institution | Haifa | 34362 | Israel |
| Local Institution | Jerusalem | 91031 | Israel |
| Local Institution | Nazareth | 16100 | Israel |
| Local Institution | Ramat Gan | 52621 | Israel |
| Local Institution | Bergamo | 24127 | Italy |
| Local Institution | Cisanello (pisa) | 56124 | Italy |
| Local Institution | Milan | 20121 | Italy |
| Local Institution | Roma | 00149 | Italy |
| Local Institution | Torino | 10126 | Italy |
| Local Institution | Bialystok | 15-540 | Poland |
| Local Institution | Kielce | 25-726 | Poland |
| Local Institution | Mysłowice | 41-400 | Poland |
| Local Institution | Racibórz | 47-400 | Poland |
| Local Institution | Wroclaw | 50-220 | Poland |
| Local Institution | Łańcut | 37-100 | Poland |
| Local Institution | Kazan' | Tatarstan Republic | 420012 | Russia |
| Local Institution | Moscow | 105275 | Russia |
| Local Institution | Moscow | 107996 | Russia |
| Local Institution | Moscow | 111123 | Russia |
| Local Institution | Moscow | 115446 | Russia |
| Local Institution | Moscow | 117198 | Russia |
| Local Institution | Moscow | 117593 | Russia |
| Local Institution | Moscow | 127015 | Russia |
| Local Institution | Saint Petersburg | 194100 | Russia |
| Local Institution | Saint Petersburg | 198103 | Russia |
| Local Institution | Stavropol | 355017 | Russia |
| Local Institution | A Coruña | 15006 | Spain |
| Local Institution | Alicante | 03010 | Spain |
| Local Institution | Donostia / San Sebastian | 20014 | Spain |
| Local Institution | Santiago de Compostela | 15706 | Spain |
| Local Institution | Seville | 41013 | Spain |
| Local Institution | Seville | 41014 | Spain |
| Local Institution | Basel | 4031 | Switzerland |
| Local Institution | Zurich | 8091 | Switzerland |
| Local Institution | Birmingham | WEST Midlands | B15 2TH | United Kingdom |
| FG001 | Part B: Peginterferon Lambda-1a + RBV + TVR | Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. |
| FG002 | Part B: Peginterferon Alfa-2a + RBV + TVR | Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-up Period |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Participants with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. |
| BG001 | Part B: Peginterferon Lambda-1a + RBV + TVR | Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. |
| BG002 | Part B: Peginterferon Alfa-2a + RBV + TVR | Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. |
| BG003 | 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 | Count of Participants | 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 | Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A | eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL). | The analysis was performed using Modified Intent-to-Treat method, defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Assessed at Week 4 and Week 12, week 12 reported |
|
|
| |||||||||||||||||||||||||
| Primary | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B | SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL). | The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Follow-up Week 12 |
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal product. An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or caused prolongation of existing hospitalization. | Safety analysis included all treated participants. | Posted | Count of Participants | Participants | Day 1 of treatment up to Week 48 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A | SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ =25 IU/mL; limit of detection ~ 10 IU/mL). | The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Follow-up Week 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A | SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection ~ 10 IU/mL). The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants. | Analysis was performed using Observed value method, defined as proportions of participants meeting response criteria in numerator and denominator - all treated participants with HCV RNA measured at follow-up Week 24. Analysis was performed in all treated participants with HCV RNA measured at follow-up Week 24 due to early study termination. | Posted | Number | 95% Confidence Interval | Percentage of participants | Follow up week 24 |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B | SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL). | The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treatment-naive treated participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Follow-up Week 12 |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B | Cytopenic abnormalities included anemia defined as hemoglobin <10 grams/decilitre; neutropenia defined as Absolute neutrophil count (ANC) <750 cubic millimetre (mm^3); thrombocytopenia defined as platelets <50,000 mm^3. | The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | After Day 1 of treatment up to Week 48 |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B | eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL). | The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 4 and Week 12 |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B | Flu-like symptoms included pyrexia, chills, and pain. Musculoskeletal symptoms included arthralgia, myalgia, and back pain. | The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | After Day 1 of treatment up to Week 48 |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B | SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection ~ 10 IU/mL). | Analysis was performed using Observed value method, defined as proportions of participants meeting response criteria in numerator and denominator - all treated participants with HCV RNA measured at follow-up Week 24. Analysis was performed in all treated participants with HCV RNA measured at follow-up Week 24 due to early study termination. | Posted | Number | 95% Confidence Interval | Percentage of participants | Follow-up Week 24 |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Rash | All skin reactions involving rash or rash-like events that occurred on treatment were reported. | The analysis was performed in all treated participants. | Posted | Number | Percentage of participants | After Day 1 of treatment up to Week 48 |
|
Day 1 of treatment up to Week 48
Not provided
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 | Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Participants with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. | 0 | 27 | 6 | 27 | 26 | 27 |
| EG001 | Part B: Peginterferon Lambda-1a + RBV + TVR | Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. | 1 | 411 | 43 | 411 | 369 | 411 |
| EG002 | Part B: Peginterferon Alfa-2a + RBV + TVR | Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. | 1 | 206 | 20 | 206 | 197 | 206 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Systematic Assessment |
| |
| Strangulated hernia | General disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Substance-induced psychotic disorder | Psychiatric disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA version 17.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 17.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 17.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 17.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA version 17.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA version 17.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA version 17.1 | Systematic Assessment |
| |
| Pancreatic enzymes increased | Investigations | MedDRA version 17.1 | Systematic Assessment |
| |
| Carotid bruit | Investigations | MedDRA version 17.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Demyelination | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Ocular icterus | Eye disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Peptic ulcer haemorrhage | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Gastrointestinal vascular malformation | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Drug reaction with eosinophilia and systemic symptoms | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Amylase increased | Investigations | MedDRA version 17.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA version 17.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 17.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 17.1 | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA version 17.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Anal pruritus | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Anorectal discomfort | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 17.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 17.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | clinical.trials@bms.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000600496 | peginterferon lambda-1a |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| C486464 | telaprevir |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Not reported |
|
| Withdrawal by Subject |
|
| Other reasons |
|
| Lost to Follow-up |
|
| 21 - <65 years |
|
| >=65 years |
|
| Male |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
|
|
| OG002 | Part B: Peginterferon Alfa-2a + RBV + TVR | Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. |
|
|