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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002356-27 | EudraCT Number |
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This is a randomized, multi-site, placebo-controlled trial of a fixed dose combination (FDC) of grazoprevir (MK-5172) 100 mg + elbasvir (MK-8742) 50 mg in participants with chronic Hepatitis C Virus (HCV) genotype (GT) 1, GT4 or GT6 with inherited blood disorders. The primary hypothesis is that the proportion of participants treated with grazoprevir+elbasvir achieving Sustained Virologic Response (SVR) 12 weeks after the end of all study therapy (SVR12) will be greater than the reference rate of 40%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Treatment | Experimental | Participants will take grazoprevir 100 mg + elbasvir 50 mg once daily during the 12-week treatment period and then will be monitored for safety during a 24-week follow-up period. |
|
| Deferred Treatment | Placebo Comparator | Participants will take placebo tablets once daily during the 12-week treatment period and will then be monitored for safety during a 4-week follow-up period. Participants will then begin open-label treatment with grazoprevir 100 mg + elbasvir 50 mg for a 12-week treatment period and will then be monitored for safety during a 24-week follow-up period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grazoprevir + Elbasvir | Drug | FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken once daily by mouth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) | The percentage of participants in the both arms achieving SVR12 (i.e., HCV riboncleic acid [RNA] level below the lower limit of quantification [LLoQ] 12 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBASâ„¢ Taqmanâ„¢ HCV Test v2.0 (High Pure System), which has a LLoQ of <15 IU/mL. | 12 weeks after completing study therapy (Week 24) |
| Percentage of Participants Experiencing an Adverse Event (AE) | An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment. | Up to Week 14 |
| Percentage of Participants Discontinuing From Study Treatment Due to an AE(s) | An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment. | Up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24) | The percentage of participants in both arms achieving SVR24 (i.e., HCV RNA level below the LLoQ 24 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBASâ„¢ Taqmanâ„¢ HCV Test v2.0 (High Pure System), which has a LLoQ of <15 IU/mL. | 24 weeks after completing study therapy (Week 36) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28256747 | Result | Hezode C, Colombo M, Bourliere M, Spengler U, Ben-Ari Z, Strasser SI, Lee WM, Morgan L, Qiu J, Hwang P, Robertson M, Nguyen BY, Barr E, Wahl J, Haber B, Chase R, Talwani R, Marco VD; C-EDGE IBLD Study Investigators. Elbasvir/Grazoprevir for Patients With Hepatitis C Virus Infection and Inherited Blood Disorders: A Phase III Study. Hepatology. 2017 Sep;66(3):736-745. doi: 10.1002/hep.29139. Epub 2017 Jul 20. | |
| 29461687 |
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Adult participants with hepatitis C virus (HCV) genotypes (GT)1, GT4, and GT6 with inherited blood disorders and with or without human immunodeficiency virus (HIV) co-infection were recruited at study centers around the world.
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Treatment | Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period. |
| FG001 | Deferred Treatment | Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Treatment | Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period. |
| BG001 | Deferred Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) | The percentage of participants in the both arms achieving SVR12 (i.e., HCV riboncleic acid [RNA] level below the lower limit of quantification [LLoQ] 12 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBASâ„¢ Taqmanâ„¢ HCV Test v2.0 (High Pure System), which has a LLoQ of <15 IU/mL. | The Full Analysis Set (FAS) consists of all treated participants in both arms other than those who discontinued with reasons unrelated to the treatment regimen or HCV response. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 weeks after completing study therapy (Week 24) |
|
Up to 52 weeks
An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment. AEs were reported for all participants receiving ≥ 1 dose of study treatment.
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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 | Immediate Treatment | Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v. 19.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA v. 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Glocal Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C000611265 | elbasvir-grazoprevir drug combination |
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| Placebo | Drug | Placebo tablets matching grazoprevir + elbasvir FDC tablets taken once daily by mouth. |
|
| Derived |
| Asselah T, Reesink H, Gerstoft J, de Ledinghen V, Pockros PJ, Robertson M, Hwang P, Asante-Appiah E, Wahl J, Nguyen BY, Barr E, Talwani R, Serfaty L. Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis. Liver Int. 2018 Sep;38(9):1583-1591. doi: 10.1111/liv.13727. Epub 2018 Mar 31. |
| Withdrawal by Subject |
|
Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Deferred Treatment | Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period. |
|
|
| Primary | Percentage of Participants Experiencing an Adverse Event (AE) | An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment. | The All-Participants-as-Treated (APaT) population includes all participants receiving ≥1 dose(s) of study drug. For the Deferred Treatment arm, data indicate results obtained during the initial 12-week placebo treatment period. | Posted | Number | Percentage of Participants | Up to Week 14 |
|
|
|
|
| Primary | Percentage of Participants Discontinuing From Study Treatment Due to an AE(s) | An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment. | The APaT population includes all participants receiving ≥1 dose(s) of study drug. For the Deferred Treatment arm, data indicate results obtained during the initial 12-week placebo treatment period. | Posted | Number | Percentage of Participants | Up to Week 12 |
|
|
|
|
| Secondary | Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24) | The percentage of participants in both arms achieving SVR24 (i.e., HCV RNA level below the LLoQ 24 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBASâ„¢ Taqmanâ„¢ HCV Test v2.0 (High Pure System), which has a LLoQ of <15 IU/mL. | The FAS consists of all treated participants in both arms other than those who discontinued with reasons unrelated to the treatment regimen or HCV response. | Posted | Number | 95% Confidence Interval | Percentage of participants | 24 weeks after completing study therapy (Week 36) |
|
|
|
| 6 |
| 107 |
| 78 |
| 107 |
| EG001 | Deferred Treatment: Placebo Phase | Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period. | 6 | 52 | 34 | 52 |
| Sickle cell anaemia with crisis | Blood and lymphatic system disorders | MedDRA v. 19.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA v. 19.0 | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | MedDRA v. 19.0 | Systematic Assessment |
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| Gastritis erosive | Gastrointestinal disorders | MedDRA v. 19.0 | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v. 19.0 | Systematic Assessment |
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| Hepatitis acute | Hepatobiliary disorders | MedDRA v. 19.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA v. 19.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA v. 19.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA v. 19.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA v. 19.0 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v. 19.0 | Systematic Assessment |
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| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA v. 19.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v. 19.0 | Systematic Assessment |
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| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA v. 19.0 | Systematic Assessment |
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| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v. 19.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA v. 19.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v. 19.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v. 19.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA v. 19.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA v. 19.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA v. 19.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA v. 19.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v. 19.0 | Systematic Assessment |
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| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA v. 19.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v. 19.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v. 19.0 | Systematic Assessment |
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The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |